xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002464</url>
    </required_header>
    <id_info>
      <org_study_id>VMEC ANEST 16</org_study_id>
      <nct_id>NCT06002464</nct_id>
    </id_info>
    <brief_title>Benefit of Acupuncture Combined to Regional Analgesia for Post Operative Pain Relief After Hysterectomy</brief_title>
    <acronym>RAACU</acronym>
    <official_title>Benefit of Acupuncture Combined to Regional Analgesia for Post Operative Pain Relief After Hysterectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vinmec Healthcare System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vinmec Healthcare System</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Since the 90's, the quality of the post operative pain relief is a main concern in most of&#xD;
        the healthcare systems in the world. An efficient pain relief improves the quality of&#xD;
        recovery after surgery [Level 1A], reduces the risk of persistent pain [level 1A] and makes&#xD;
        the patients satisfied.&#xD;
  &#xD;
        Continuous regional anesthesia/analgesia promotes a level 1A in quality of postoperative pain&#xD;
        relief, reduction in opioids consumption in opioid sparing/free analgesia programs, time to&#xD;
        recover and the reduction of hospital stay. However in the postoperative period, breakthrough&#xD;
        pain episodes due to mobilization or activity are not well covered by regional analgesia.&#xD;
        Furthermore, after removal of the catheter of regional anesthesia, patients may face an&#xD;
        unpleasant rebound pain effect.&#xD;
  &#xD;
        At VinMec, the technique of regional anesthesia chosen to provide regional analgesia after&#xD;
        hysterectomy is a bilateral erector spinae plane block .&#xD;
  &#xD;
        Traditional Medicine relieves pain by non-pharmacological methods, especially by acupuncture&#xD;
        which bring positive results. Acupuncture has been proven to provide pain relief according to&#xD;
        the mechanism of traditional and modern medicine, safe for patients and with few side&#xD;
        effects. The acupunture point formula is used by VinMec Sao Phuong Dong Traditional Medicine&#xD;
        Center in conjunction with the department of Anesthesiology and Pain management in VinMec&#xD;
        Times City International General Hospital to relieve pain after hysterectomy including: Three&#xD;
        Yin Intersection (SP-6), Leg Three Miles (ST-36), Taichong (LR-3), Xuehai (SP-10).&#xD;
  &#xD;
        The study is to observe the effect of combining acupuncture with regional anesthesia on pain&#xD;
        relief and postoperative recovery in patients undergoing hysterectomy.&#xD;
  &#xD;
        There is no published study regarding the effects of combining the 2 techniques above as&#xD;
        multimodal approach for post operative analgesia after hysterectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Design A single center, open label, prospective randomized controlled trial to study the&#xD;
        benefits of combining acupuncture with bilateral continuous ESPB compared to bilateral ESPB&#xD;
        alone in patients scheduled for an hysterectomy .&#xD;
  &#xD;
        Patient selection At the pre-anesthetic consultation or performed at least 24h before the&#xD;
        surgery.&#xD;
  &#xD;
        Enrollment and allocation During the pre-anesthetic consultation, if the patient accepts the&#xD;
        proven benefits to have surgery performed under combined general anesthesia and regional&#xD;
        anesthesia, the anesthesiologist will offer her to participate in the study comparing these&#xD;
        two bundles of care using regional anesthesia.&#xD;
  &#xD;
        Patients will be assigned via a random number generator into one of two study groups (1 Or 2)&#xD;
        by the physician/nurse who obtained consent which is prescribed in the nurse preparation&#xD;
        file.&#xD;
  &#xD;
        Surgical technique Elective hysterectomy by laparoscopic or Pfannenstiel incision&#xD;
  &#xD;
        GROUP 1: ESPB&#xD;
  &#xD;
        The ESPB will be performed after the induction of general anesthesia (Décris ton régime&#xD;
        d'anesthésie générale). (Kit epidural for adult Tuohy needle 19 G Catheter 20G, Name&#xD;
        company). Once hemodynamically stable, the patient will be placed on right lateral decubitus.&#xD;
        Right and left side level of puncture is on transverse process of T8 in cephalo-caudal&#xD;
        direction. The tip of the catheter should be on the transverse process of T9.&#xD;
  &#xD;
        During the ultrasound-guided procedure, the ESP space was located by injecting dextrose 5% to&#xD;
        lift up the fascia of the erector spinae muscles off the transverse process. There should be&#xD;
        a visible spread of fluid in both cephalad and caudal directions and demonstration of a&#xD;
        breathing sign. The catheter 20G will be inserted into this space under US guidance,&#xD;
        visualizing the tip of the catheter on the top of the next transverse process, as described&#xD;
        above. The catheter placement will be tested by injecting dextrose 5% and demonstrating a&#xD;
        cephalo-caudal spread of the liquid in the inter-fascial plane anterior to the ESP muscle.&#xD;
        Induction of ESP block will be done 30 min before incision with ropivacaine 0.5% with loading&#xD;
        dose as follows:&#xD;
  &#xD;
        Patient height (cm) Volume of LA (mL) LEFT RIGHT 140-149 8 6 150-159 10 8 160-169 12 10&#xD;
        170-180 14 12 &gt;180 16 14&#xD;
  &#xD;
        Group 2: ESPB combined to Acupuncture Patient will have ESP bilateral catheter as per group 1&#xD;
  &#xD;
        Three hours after the surgery, acupuncture will be performed as per the following protocol:&#xD;
  &#xD;
        Acupuncture point formula&#xD;
  &#xD;
          1. Three Yin Intersection (SP-6): 3 cun above the the highest point of the ankle bone, one&#xD;
             finger's breatdth from the posterior border of the tibia&#xD;
  &#xD;
          2. Leg Three Miles (ST-36): 3 cun below the knee crease, and approximately one finger's&#xD;
             breadth lateral to the tibial crest. It is located near the anterior shin bone muscle,&#xD;
             and in a depression between the the fibula and tibia..&#xD;
  &#xD;
          3. Taichong (LR-3): put the foot flat on the floor, on the dorsum of the foot, find the&#xD;
             point in a depression distal to the junctions of the 1st and 2nd metatarsal bones.&#xD;
  &#xD;
          4. Xuehai (SP-10): on the medial border of the patella, in the middle of vastus medialis&#xD;
             and sartorius muscle.&#xD;
  &#xD;
        Material Acupuncture needle, diameter = 0.25mm, 4cm long, needle material: SUS 304;&#xD;
        manufactured by Van Long Medical Equipment Co., Ltd, Wujiang City, China.&#xD;
  &#xD;
        Sessions of Acupuncture The patient lies in supine position, with two legs exposed.&#xD;
        Acupuncture for 30 minutes,&#xD;
  &#xD;
          -  At Day 0 The first session will be 3 hours after arrival time in post operative care&#xD;
             unit&#xD;
  &#xD;
          -  At day 1 2 and 3, 2 sessions per day, at 8 am and 3 pm (acupuncture done before the&#xD;
             patient starts to do exercises).&#xD;
  &#xD;
        Acupuncture performed on both legs. Order of acupuncture points: Three Yin Intersection&#xD;
        (SP-6), Leg Three Miles (ST-36), Taichong (LR-3), Xuehai (SP-10)&#xD;
  &#xD;
        Acupuncture performed in 2 steps:&#xD;
  &#xD;
          -  Step 1: needles puncture through the skin at the acupuncture points quickly and&#xD;
             decisively.&#xD;
  &#xD;
          -  Step 2: When needle depth is about 0.5-1cm, manipulate the needle every 10 minutes&#xD;
             counterclockwise. At Taichong (LR-3), manipulate the needle every 10 minutes&#xD;
             counter-clockwise&#xD;
  &#xD;
        Statistical consideration Statistical analysis The study is a superior comparative trial.&#xD;
        Patients scheduled for hysterectomy will be randomized into 2 groups: a group receiving&#xD;
        standard of care ESPB and a group receiving ESPB + acupuncture. Comparison between groups&#xD;
        done for primary and secondary outcomes.&#xD;
  &#xD;
        Sample size Assuming the difference in VAS score between two group is 1, variance of VAS&#xD;
        score is 2 and equal between two groups, for 95% CI and power of 80%, 32 participants are&#xD;
        needed for each group. Assuming loss of follow-up is 10%, a total of 72 participants (36 for&#xD;
        each group) is needed.&#xD;
  &#xD;
        Analysis plan For primary outcome (VAS score), t-test will be used for the comparison between&#xD;
        group. For secondary outcomes, Mann-Whitney test will be used for continuous outcomes and&#xD;
        Fisher's exact test will be used for categorical outcomes. All statistical tests are 2 sided&#xD;
        with significant level of 0.05.&#xD;
  &#xD;
        All analysis will be done with latest version of R statistical software.&#xD;
  &#xD;
        Data collection For the first 3 postoperative days, data will be recorded during routine&#xD;
        patient rounds done by the anesthesia team in the ICU and surgical ward. Another set of data&#xD;
        will be recorded after one month, during routine patient follow-up.&#xD;
  &#xD;
        All data will be retrieved from the patient records except for opioid consumption which will&#xD;
        be obtained from the PCA pumps. Opioid consumption will be recalculated to morphine milligram&#xD;
        equivalents (MMEs).&#xD;
  &#xD;
        For pain evaluation, VAS score will be assessed every 2 hours after extubation for 3&#xD;
        consecutive times, and every 8 hours thereafter. Please see table below.&#xD;
  &#xD;
        A dedicated anesthesia nurse trained for data collection will follow the patient and collect&#xD;
        the data&#xD;
  &#xD;
        V. ETHICS Independent Ethics Committee or Institutional Review Board Approval will be&#xD;
        obtained from VinMec ethical committee (IRB) and signed by the IRB/IEC chairman or designee&#xD;
        before human participants participate in research studies. Before study onset, the protocol,&#xD;
        informed consent, advertisements to be used for the recruitment of study participants, and&#xD;
        any other written information regarding this study to be provided to the participant or the&#xD;
        participant's legal guardian must be approved by the IRB/IEC. Good Clinical Practice (GCP)&#xD;
        will be maintained and will be available for review by the Sponsor or its designee.&#xD;
  &#xD;
        The investigator is responsible for providing written summaries of the progress and status of&#xD;
        the study and written reports on any changes significantly affecting the conduct of the study&#xD;
        or increasing the risk to participants.&#xD;
  &#xD;
        The study will be performed in accordance with the ethical principles that originated from&#xD;
        the Declaration of Helsinki, ICH GCP, and all applicable regulations.&#xD;
  &#xD;
        Participant Information and Consent A written informed consent shall be obtained from each&#xD;
        participant before entering the study or performing any unusual or nonroutine procedure that&#xD;
        involves risk to the participant.&#xD;
  &#xD;
        Before recruitment and enrollment, each prospective participant or his or her legal guardian&#xD;
        will be given a full explanation of the study, allowed to read the approved ICF, and allowed&#xD;
        to have any questions answered. Once the investigator is assured that the participant/legal&#xD;
        guardian understands the implications of participating in the study, the participant/legal&#xD;
        guardian will be asked to give consent to participate in the study by signing the ICF. The&#xD;
        authorized person obtaining the informed consent will also sign the ICF.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A single center, open label, prospective randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>quality of pain relief</measure>
      <time_frame>from end of surgery to 3rd day after the surgery</time_frame>
      <description>the area under the curves the Visual analgesia Scores for pain at rest and pain at mobilization</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Opioid consumption</measure>
      <time_frame>from end of surgery to 3rd day after the surgery</time_frame>
      <description>the total morphine consumption used to reach the desired level of pain control</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of recovery</measure>
      <time_frame>measured on 4th day after surgery</time_frame>
      <description>By using a published score of quality of recovery after anesthesia for surgery, the QOR 15</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Pain, Postoperative</condition>
    <arm_group>
      <arm_group_label>ESP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Post operative analgesia with bilateral continuous erector spinae plane block catheter</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ESP ACU</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Post operative analgesia with bilateral continuous erector spinae plane block catheter combined with daily session of acupuncture</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Acupuncture</intervention_name>
      <description>Patient will have session of 30 minutes of acupuncture every day during 3 days</description>
      <arm_group_label>ESP ACU</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bilateral ESP catheter</intervention_name>
      <description>Analgesia by Bilateral Continuous erector spine plane block catheter at T9 level for 2 days</description>
      <arm_group_label>ESP</arm_group_label>
      <arm_group_label>ESP ACU</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  female&#xD;
  &#xD;
            -  elective hysterectomy&#xD;
  &#xD;
            -  accept ton participate&#xD;
  &#xD;
            -  signed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patient refusal&#xD;
  &#xD;
            -  allergy to local anesthetics&#xD;
  &#xD;
            -  complex congenital malformation&#xD;
  &#xD;
            -  mental deficit&#xD;
  &#xD;
            -  substance abuse(alcohol, drugs, opioids)&#xD;
  &#xD;
            -  renal insufficiency&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Patients listed for hysterectomy</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Philippe Macaire, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vinmec Healthcare System</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Huyen Vu</last_name>
      <phone>(024)39750028</phone>
      <phone_ext>6280</phone_ext>
      <email>v.huyenvx@vinmec.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Vinmec international hospital</name>
        <address>
          <city>Hanoi</city>
          <zip>10000</zip>
          <country>Vietnam</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Philippe Macaire</last_name>
        <email>ph.macaire@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Vietnam</country>
    </location_countries>
    <results_reference>
      <citation>Andreae MH, Andreae DA. Local anaesthetics and regional anaesthesia for preventing chronic pain after surgery. Cochrane Database Syst Rev. 2012 Oct 17;10:CD007105. doi: 10.1002/14651858.CD007105.pub2.</citation>
      <PMID>23076930</PMID>
    </results_reference>
    <results_reference>
      <citation>Weinstein EJ, Levene JL, Cohen MS, Andreae DA, Chao JY, Johnson M, Hall CB, Andreae MH. Local anaesthetics and regional anaesthesia versus conventional analgesia for preventing persistent postoperative pain in adults and children. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD007105. doi: 10.1002/14651858.CD007105.pub3.</citation>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002464
  org study id: VMEC ANEST 16
  nct id: NCT06002464
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Since the 90's, the quality of the post operative pain relief is a main concern in most of
        the healthcare systems in the world. An efficient pain relief improves the quality of
        recovery after surgery [Level 1A], reduces the risk of persistent pain [level 1A] and makes
        the patients satisfied.
  
        Continuous regional anesthesia/analgesia promotes a level 1A in quality of postoperative pain
        relief, reduction in opioids consumption in opioid sparing/free analgesia programs, time to
        recover and the reduction of hospital stay. However in the postoperative period, breakthrough
        pain episodes due to mobilization or activity are not well covered by regional analgesia.
        Furthermore, after removal of the catheter of regional anesthesia, patients may face an
        unpleasant rebound pain effect.
  
        At VinMec, the technique of regional anesthesia chosen to provide regional analgesia after
        hysterectomy is a bilateral erector spinae plane block .
  
        Traditional Medicine relieves pain by non-pharmacological methods, especially by acupuncture
        which bring positive results. Acupuncture has been proven to provide pain relief according to
        the mechanism of traditional and modern medicine, safe for patients and with few side
        effects. The acupunture point formula is used by VinMec Sao Phuong Dong Traditional Medicine
        Center in conjunction with the department of Anesthesiology and Pain management in VinMec
        Times City International General Hospital to relieve pain after hysterectomy including: Three
        Yin Intersection (SP-6), Leg Three Miles (ST-36), Taichong (LR-3), Xuehai (SP-10).
  
        The study is to observe the effect of combining acupuncture with regional anesthesia on pain
        relief and postoperative recovery in patients undergoing hysterectomy.
  
        There is no published study regarding the effects of combining the 2 techniques above as
        multimodal approach for post operative analgesia after hysterectomy.
  Design A single center, open label, prospective randomized controlled trial to study the
        benefits of combining acupuncture with bilateral continuous ESPB compared to bilateral ESPB
        alone in patients scheduled for an hysterectomy .
  
        Patient selection At the pre-anesthetic consultation or performed at least 24h before the
        surgery.
  
        Enrollment and allocation During the pre-anesthetic consultation, if the patient accepts the
        proven benefits to have surgery performed under combined general anesthesia and regional
        anesthesia, the anesthesiologist will offer her to participate in the study comparing these
        two bundles of care using regional anesthesia.
  
        Patients will be assigned via a random number generator into one of two study groups (1 Or 2)
        by the physician/nurse who obtained consent which is prescribed in the nurse preparation
        file.
  
        Surgical technique Elective hysterectomy by laparoscopic or Pfannenstiel incision
  
        GROUP 1: ESPB
  
        The ESPB will be performed after the induction of general anesthesia (Décris ton régime
        d'anesthésie générale). (Kit epidural for adult Tuohy needle 19 G Catheter 20G, Name
        company). Once hemodynamically stable, the patient will be placed on right lateral decubitus.
        Right and left side level of puncture is on transverse process of T8 in cephalo-caudal
        direction. The tip of the catheter should be on the transverse process of T9.
  
        During the ultrasound-guided procedure, the ESP space was located by injecting dextrose 5% to
        lift up the fascia of the erector spinae muscles off the transverse process. There should be
        a visible spread of fluid in both cephalad and caudal directions and demonstration of a
        breathing sign. The catheter 20G will be inserted into this space under US guidance,
        visualizing the tip of the catheter on the top of the next transverse process, as described
        above. The catheter placement will be tested by injecting dextrose 5% and demonstrating a
        cephalo-caudal spread of the liquid in the inter-fascial plane anterior to the ESP muscle.
        Induction of ESP block will be done 30 min before incision with ropivacaine 0.5% with loading
        dose as follows:
  
        Patient height (cm) Volume of LA (mL) LEFT RIGHT 140-149 8 6 150-159 10 8 160-169 12 10
        170-180 14 12 >180 16 14
  
        Group 2: ESPB combined to Acupuncture Patient will have ESP bilateral catheter as per group 1
  
        Three hours after the surgery, acupuncture will be performed as per the following protocol:
  
        Acupuncture point formula
  
          1. Three Yin Intersection (SP-6): 3 cun above the the highest point of the ankle bone, one
             finger's breatdth from the posterior border of the tibia
  
          2. Leg Three Miles (ST-36): 3 cun below the knee crease, and approximately one finger's
             breadth lateral to the tibial crest. It is located near the anterior shin bone muscle,
             and in a depression between the the fibula and tibia..
  
          3. Taichong (LR-3): put the foot flat on the floor, on the dorsum of the foot, find the
             point in a depression distal to the junctions of the 1st and 2nd metatarsal bones.
  
          4. Xuehai (SP-10): on the medial border of the patella, in the middle of vastus medialis
             and sartorius muscle.
  
        Material Acupuncture needle, diameter = 0.25mm, 4cm long, needle material: SUS 304;
        manufactured by Van Long Medical Equipment Co., Ltd, Wujiang City, China.
  
        Sessions of Acupuncture The patient lies in supine position, with two legs exposed.
        Acupuncture for 30 minutes,
  
          -  At Day 0 The first session will be 3 hours after arrival time in post operative care
             unit
  
          -  At day 1 2 and 3, 2 sessions per day, at 8 am and 3 pm (acupuncture done before the
             patient starts to do exercises).
  
        Acupuncture performed on both legs. Order of acupuncture points: Three Yin Intersection
        (SP-6), Leg Three Miles (ST-36), Taichong (LR-3), Xuehai (SP-10)
  
        Acupuncture performed in 2 steps:
  
          -  Step 1: needles puncture through the skin at the acupuncture points quickly and
             decisively.
  
          -  Step 2: When needle depth is about 0.5-1cm, manipulate the needle every 10 minutes
             counterclockwise. At Taichong (LR-3), manipulate the needle every 10 minutes
             counter-clockwise
  
        Statistical consideration Statistical analysis The study is a superior comparative trial.
        Patients scheduled for hysterectomy will be randomized into 2 groups: a group receiving
        standard of care ESPB and a group receiving ESPB + acupuncture. Comparison between groups
        done for primary and secondary outcomes.
  
        Sample size Assuming the difference in VAS score between two group is 1, variance of VAS
        score is 2 and equal between two groups, for 95% CI and power of 80%, 32 participants are
        needed for each group. Assuming loss of follow-up is 10%, a total of 72 participants (36 for
        each group) is needed.
  
        Analysis plan For primary outcome (VAS score), t-test will be used for the comparison between
        group. For secondary outcomes, Mann-Whitney test will be used for continuous outcomes and
        Fisher's exact test will be used for categorical outcomes. All statistical tests are 2 sided
        with significant level of 0.05.
  
        All analysis will be done with latest version of R statistical software.
  
        Data collection For the first 3 postoperative days, data will be recorded during routine
        patient rounds done by the anesthesia team in the ICU and surgical ward. Another set of data
        will be recorded after one month, during routine patient follow-up.
  
        All data will be retrieved from the patient records except for opioid consumption which will
        be obtained from the PCA pumps. Opioid consumption will be recalculated to morphine milligram
        equivalents (MMEs).
  
        For pain evaluation, VAS score will be assessed every 2 hours after extubation for 3
        consecutive times, and every 8 hours thereafter. Please see table below.
  
        A dedicated anesthesia nurse trained for data collection will follow the patient and collect
        the data
  
        V. ETHICS Independent Ethics Committee or Institutional Review Board Approval will be
        obtained from VinMec ethical committee (IRB) and signed by the IRB/IEC chairman or designee
        before human participants participate in research studies. Before study onset, the protocol,
        informed consent, advertisements to be used for the recruitment of study participants, and
        any other written information regarding this study to be provided to the participant or the
        participant's legal guardian must be approved by the IRB/IEC. Good Clinical Practice (GCP)
        will be maintained and will be available for review by the Sponsor or its designee.
  
        The investigator is responsible for providing written summaries of the progress and status of
        the study and written reports on any changes significantly affecting the conduct of the study
        or increasing the risk to participants.
  
        The study will be performed in accordance with the ethical principles that originated from
        the Declaration of Helsinki, ICH GCP, and all applicable regulations.
  
        Participant Information and Consent A written informed consent shall be obtained from each
        participant before entering the study or performing any unusual or nonroutine procedure that
        involves risk to the participant.
  
        Before recruitment and enrollment, each prospective participant or his or her legal guardian
        will be given a full explanation of the study, allowed to read the approved ICF, and allowed
        to have any questions answered. Once the investigator is assured that the participant/legal
        guardian understands the implications of participating in the study, the participant/legal
        guardian will be asked to give consent to participate in the study by signing the ICF. The
        authorized person obtaining the informed consent will also sign the ICF.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A single center, open label, prospective randomized controlled trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: quality of pain relief
  time frame: from end of surgery to 3rd day after the surgery
  description: the area under the curves the Visual analgesia Scores for pain at rest and pain at mobilization
  measure: Opioid consumption
  time frame: from end of surgery to 3rd day after the surgery
  description: the total morphine consumption used to reach the desired level of pain control
  measure: Quality of recovery
  time frame: measured on 4th day after surgery
  description: By using a published score of quality of recovery after anesthesia for surgery, the QOR 15
  arm group label: ESP
  arm group type: Active Comparator
  description: Post operative analgesia with bilateral continuous erector spinae plane block catheter
  arm group label: ESP ACU
  arm group type: Experimental
  description: Post operative analgesia with bilateral continuous erector spinae plane block catheter combined with daily session of acupuncture
  intervention type: Procedure
  intervention name: Acupuncture
  description: Patient will have session of 30 minutes of acupuncture every day during 3 days
  arm group label: ESP ACU
  intervention type: Procedure
  intervention name: Bilateral ESP catheter
  description: Analgesia by Bilateral Continuous erector spine plane block catheter at T9 level for 2 days
  arm group label: ESP
  arm group label: ESP ACU
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Patients listed for hysterectomy
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Philippe Macaire, MD
  role: Principal Investigator
  affiliation: Vinmec Healthcare System
  last name: Huyen Vu
  phone: (024)39750028
  phone ext: 6280
  email: v.huyenvx@vinmec.com
  facility: 
  status: Recruiting
  contact: 
  country: Vietnam
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  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  sharing ipd: No