<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/NCT02984865</url>
  </required_header>
  <id_info>
    <org_study_id>PJ-2016-09-05</org_study_id>
    <nct_id>NCT02984865</nct_id>
  </id_info>
  <brief_title>The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Clinical Anesthesia</brief_title>
  <official_title>The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Peritoneal Dialysis Catheter Placement and Analgesia Based on Transversus Abdominis Plane Block Combined With κ Receptor Agonist and NSAID(Non-steroidal Anti-inflammatory Drug ) Following Open Gastrointestinal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Anhui Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Peritoneal dialysis (PD) catheter placement surgery for patients with end-stage renal disease&#xD;
      (ESRD) can be performed under peripheral nerve block. This study assessed the ability of&#xD;
      ultrasound guided left lateral transversus abdominis plane (TAP) block combined with rectus&#xD;
      sheath (RS) block in PD catheter placement surgery. Also, surgeries are common surgeries&#xD;
      performed in elderly patients throughout the world. Although there is an increasing trend&#xD;
      towards laparoscopic surgeries, open procedures continue to remain common therapeutic&#xD;
      modalities especially in the developing countries. Pain is reported more commonly in patients&#xD;
      undergoing open procedures than laparoscopic procedures. Postoperative pain and tissue injury&#xD;
      associated with surgery initiated a systemic stress response which has neuroendocrine,&#xD;
      immunological, and haematological responses. Opioids are an important modality of&#xD;
      postoperative pain management. They blunt the neuroendocrine stress response to pain.&#xD;
      However, they are associated with several adverse effects like respiratory depression,&#xD;
      nausea, vomiting , pruritus, constipation, urinary retension, bradycardia and hypotension.&#xD;
      Transversus abdominis plane block（TAPB）is a relative novel procedure in which local&#xD;
      anesthetic agents are injected into the anatomic plane between the internal oblique and the&#xD;
      transversus abdominis muscle. It allows a significantly prolonged duration of analgesia&#xD;
      during the early postoperative stage in abdominal surgery. This regional anesthesia technique&#xD;
      provides analgesia to the skin, muscles of the anterior abdominal wall and parietal&#xD;
      peritoneum in order to decrease the incision-related pain. Thus, it reduces postoperative&#xD;
      opiate requirements and opioids-related side effects (nausea, vomiting, delayed resumption of&#xD;
      intestinal transit, drowsiness, respiratory depression, urine retention). Nalbuphine, being&#xD;
      mu antagonist an kappa agonist, has a ceiling effect in its respiratory depression. Many&#xD;
      studies have reported that incidence of adverse effects like pruritus and PONV is lower with&#xD;
      nalbuphine in comparison with morphine. The purpose of this study is to compare the analgesic&#xD;
      efficacy and side effect profile of sulfentanyl with nalbuphine in elderly patients&#xD;
      undergoing open gastrointestinal surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted in the department of Anesthesiology of the first affiliated&#xD;
      hospital of Anhui Medical University, Hefei city, Anhui province, China. In our part 1, we&#xD;
      are plan to observe 30 patients with ESRD who underwent PD catheter placement using left&#xD;
      lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block from&#xD;
      our center. The TAP and RS blocks will be respectively conducted with 15 ml of 0.5%&#xD;
      ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity will be evaluated by verbal rating&#xD;
      scale (VRS), and the degree of patient and surgeon satisfaction will be qualified by a&#xD;
      categorical scale. In part 2, the sample size was calculated based on the previous data in&#xD;
      our hospital using sulfentanyl and flurbiprofen axetil as the opioid analgesic. The rate of&#xD;
      postoperative nausea and vomiting(PONV) after surgery was 35%. Keeping the power of the study&#xD;
      as 80% and 5% alpha error with the number of pairwise comparisons as 6, a total sample size&#xD;
      of 124 was needed to identify a difference of 0.25 in the rate of PONV. Each group would&#xD;
      require at least 31 patients. To allow for dropouts, the investigator decided to include 40&#xD;
      patients in each group. Elderly patients who were over 65 years old, undergoing open&#xD;
      gastrointestinal surgeries were included in the study. Patients were divided into four&#xD;
      groups, that is group S, group N1, group N2 and group N3, based on the drawing of an opaque&#xD;
      sealed envelop.The anesthesiologists managing the intraoperative and postoperative courses as&#xD;
      well as patients were blinded to the group which they belonged.The drug solution to be used&#xD;
      intraoperatively and postoperatively as PCA (patient-controlled analgesia) was prepared by an&#xD;
      assistant. Patients were interviewed before surgery and informed written consent was taken&#xD;
      form each patient. Patients were shown a VAS (visual analogue score) of 0-10 for pain with 0&#xD;
      being no pain and 10 being worst pain ever felt, and instructed upon the use of PCA&#xD;
      (patient-controlled analgesia) before surgery. Patients were subjected to monitoring of ECG,&#xD;
      pulse oximetry and invasive blood pressure. 20ml combination of 0.5% ropivacaine and 10mg&#xD;
      dexamethasone was injected bilaterally between the internal oblique and transverse abdominis&#xD;
      muscles using sonography. All groups received standard general anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 20, 2016</start_date>
  <completion_date type="Anticipated">May 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 8, 2018</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>The first group was designed to observe the advantage of transversus abdominis plane (TAP) block combined with rectus sheath (RS) block in PD catheter placement surgery, which is independent from other 4 groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative nausea and vomiting</measure>
    <time_frame>48 hours after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>verbal rating scale</measure>
    <time_frame>during surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative visual analogue scale of pain</measure>
    <time_frame>48 hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative Ramsay of sedation</measure>
    <time_frame>48 hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>first time for out of bed activity after surgery</measure>
    <time_frame>7days after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Postoperative Nausea and Vomiting</condition>
  <condition>Surgery</condition>
  <condition>Anesthesia</condition>
  <condition>Peritoneal Dialysis</condition>
  <condition>Rectus Sheath Block</condition>
  <arm_group>
    <arm_group_label>group S</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were attach with PCA containing 100ml combination of sulfentanyl 2.5ug/kg and flubiprofen axetil 100mg after receiving the loading dose of sulfentanyl 5 ug and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group N1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were attach with PCA containing 100ml combination of nalbuphine 1.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group N2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were attach with PCA containing 100ml combination of nalbuphine 2mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group N3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were attach with PCA containing 100ml combination of nalbuphine 2.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group ESRD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>30 patients with ESRD who underwent PD catheter placement using left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block from our center. The TAP and RS blocks were respectively conducted with 15 ml of 0.5% ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity was evaluated by verbal rating scale (VRS), and the degree of patient and surgeon satisfaction was qualified by a categorical scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sulfentanyl</intervention_name>
    <arm_group_label>group S</arm_group_label>
    <other_name>sulfentanil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalbuphine</intervention_name>
    <arm_group_label>group N1</arm_group_label>
    <arm_group_label>group N2</arm_group_label>
    <arm_group_label>group N3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>flubiprofen axetil</intervention_name>
    <arm_group_label>group N1</arm_group_label>
    <arm_group_label>group N2</arm_group_label>
    <arm_group_label>group N3</arm_group_label>
    <arm_group_label>group S</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>rectus sheath block</intervention_name>
    <description>Transversus abdominis plane (TAP) block combined with rectus sheath (RS) block will be applied in Group ESRD</description>
    <arm_group_label>Group ESRD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ESRD scheduled for PD catheter placement belonging to American Society&#xD;
             of Anesthesiologists (ASA) Grade 2 to 4 were included in the study.&#xD;
&#xD;
          -  Elderly patients who were over 65 years old ,undergoing open gastrointestinal&#xD;
             surgeries were included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria included patients refusal, history of abdominal surgery,&#xD;
             coagulation disorders, allergy to local anesthetic and localized infection on the&#xD;
             injection site.&#xD;
&#xD;
          -  The exclusion criteria were patient refusal, respiratory insufficiency,cardiac&#xD;
             insufficiency,liver or kidney dysfunction，history of brain disease,local anesthetic&#xD;
             allergy, dysfunction of blood coagulation，hemodynamic instability, history of any&#xD;
             chronic pain, and history of chronic opioid use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xuesheng Liu, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>The First Affiliated Hospital of Anhui Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yu Mao, postgraduate</last_name>
    <phone>+86 18019951656</phone>
    <email>maoyu163flying@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Erwei Gu, bachelor</last_name>
    <phone>+8613966663478</phone>
    <email>ay_guew_mz@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yu mao</last_name>
      <phone>+86 18019951656</phone>
      <email>maoyu163flying@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.</citation>
    <PMID>24993433</PMID>
  </reference>
  <reference>
    <citation>Zeng Z, Lu J, Shu C, Chen Y, Guo T, Wu QP, Yao SL, Yin P. A comparision of nalbuphine with morphine for analgesic effects and safety : meta-analysis of randomized controlled trials. Sci Rep. 2015 Jun 3;5:10927. doi: 10.1038/srep10927.</citation>
    <PMID>26039709</PMID>
  </reference>
  <reference>
    <citation>Kartalov A, Jankulovski N, Kuzmanovska B, Zdravkovska M, Shosholcheva M, Spirovska T, Petrusheva AP, Tolevska M, Srceva M, Durnev V, Jota G, Selmani R, Sivevski A. Effect of Adding Dexamethasone as a Ropivacaine Adjuvant in Ultrasound-Guided Transversus Abdominis Plane Block for Inguinal Hernia Repair. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):35-41. doi: 10.1515/prilozi-2015-0076.</citation>
    <PMID>27442394</PMID>
  </reference>
  <reference>
    <citation>Huang D, Ma X, Zhou D. [Effects of postoperative analgesia of ultrasound-guided transversus abdominis plane block in hemicolectomy patients]. Zhonghua Yi Xue Za Zhi. 2014 Jun 3;94(21):1623-6. Chinese.</citation>
    <PMID>25152283</PMID>
  </reference>
  <reference>
    <citation>Akshat S, Ramachandran R, Rewari V, Chandralekha, Trikha A, Sinha R. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial. Pain Res Treat. 2014;2014:727952. doi: 10.1155/2014/727952. Epub 2014 Apr 14.</citation>
    <PMID>24834352</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>February 19, 2018</last_update_submitted>
  <last_update_submitted_qc>February 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transversus plane block</keyword>
  <keyword>opioid</keyword>
  <keyword>nalbuphine</keyword>
  <keyword>gastrointestinal surgery</keyword>
  <keyword>elderly patient</keyword>
  <keyword>rectus sheath block</keyword>
  <keyword>Peritoneal dialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flurbiprofen</mesh_term>
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Nalbuphine</mesh_term>
    <mesh_term>Dsuvia</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02984865
org study id: PJ-2016-09-05
nct id: NCT02984865
lead sponsor: 
has dmc: Yes
Peritoneal dialysis (PD) catheter placement surgery for patients with end-stage renal disease
      (ESRD) can be performed under peripheral nerve block. This study assessed the ability of
      ultrasound guided left lateral transversus abdominis plane (TAP) block combined with rectus
      sheath (RS) block in PD catheter placement surgery. Also, surgeries are common surgeries
      performed in elderly patients throughout the world. Although there is an increasing trend
      towards laparoscopic surgeries, open procedures continue to remain common therapeutic
      modalities especially in the developing countries. Pain is reported more commonly in patients
      undergoing open procedures than laparoscopic procedures. Postoperative pain and tissue injury
      associated with surgery initiated a systemic stress response which has neuroendocrine,
      immunological, and haematological responses. Opioids are an important modality of
      postoperative pain management. They blunt the neuroendocrine stress response to pain.
      However, they are associated with several adverse effects like respiratory depression,
      nausea, vomiting , pruritus, constipation, urinary retension, bradycardia and hypotension.
      Transversus abdominis plane block（TAPB）is a relative novel procedure in which local
      anesthetic agents are injected into the anatomic plane between the internal oblique and the
      transversus abdominis muscle. It allows a significantly prolonged duration of analgesia
      during the early postoperative stage in abdominal surgery. This regional anesthesia technique
      provides analgesia to the skin, muscles of the anterior abdominal wall and parietal
      peritoneum in order to decrease the incision-related pain. Thus, it reduces postoperative
      opiate requirements and opioids-related side effects (nausea, vomiting, delayed resumption of
      intestinal transit, drowsiness, respiratory depression, urine retention). Nalbuphine, being
      mu antagonist an kappa agonist, has a ceiling effect in its respiratory depression. Many
      studies have reported that incidence of adverse effects like pruritus and PONV is lower with
      nalbuphine in comparison with morphine. The purpose of this study is to compare the analgesic
      efficacy and side effect profile of sulfentanyl with nalbuphine in elderly patients
      undergoing open gastrointestinal surgeries.
This study will be conducted in the department of Anesthesiology of the first affiliated
      hospital of Anhui Medical University, Hefei city, Anhui province, China. In our part 1, we
      are plan to observe 30 patients with ESRD who underwent PD catheter placement using left
      lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block from
      our center. The TAP and RS blocks will be respectively conducted with 15 ml of 0.5%
      ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity will be evaluated by verbal rating
      scale (VRS), and the degree of patient and surgeon satisfaction will be qualified by a
      categorical scale. In part 2, the sample size was calculated based on the previous data in
      our hospital using sulfentanyl and flurbiprofen axetil as the opioid analgesic. The rate of
      postoperative nausea and vomiting(PONV) after surgery was 35%. Keeping the power of the study
      as 80% and 5% alpha error with the number of pairwise comparisons as 6, a total sample size
      of 124 was needed to identify a difference of 0.25 in the rate of PONV. Each group would
      require at least 31 patients. To allow for dropouts, the investigator decided to include 40
      patients in each group. Elderly patients who were over 65 years old, undergoing open
      gastrointestinal surgeries were included in the study. Patients were divided into four
      groups, that is group S, group N1, group N2 and group N3, based on the drawing of an opaque
      sealed envelop.The anesthesiologists managing the intraoperative and postoperative courses as
      well as patients were blinded to the group which they belonged.The drug solution to be used
      intraoperatively and postoperatively as PCA (patient-controlled analgesia) was prepared by an
      assistant. Patients were interviewed before surgery and informed written consent was taken
      form each patient. Patients were shown a VAS (visual analogue score) of 0-10 for pain with 0
      being no pain and 10 being worst pain ever felt, and instructed upon the use of PCA
      (patient-controlled analgesia) before surgery. Patients were subjected to monitoring of ECG,
      pulse oximetry and invasive blood pressure. 20ml combination of 0.5% ropivacaine and 10mg
      dexamethasone was injected bilaterally between the internal oblique and transverse abdominis
      muscles using sonography. All groups received standard general anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The first group was designed to observe the advantage of transversus abdominis plane (TAP) block combined with rectus sheath (RS) block in PD catheter placement surgery, which is independent from other 4 groups.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: postoperative nausea and vomiting
time frame: 48 hours after surgery
measure: verbal rating scale
time frame: during surgery
measure: postoperative visual analogue scale of pain
time frame: 48 hours after surgery
measure: postoperative Ramsay of sedation
time frame: 48 hours after surgery
measure: first time for out of bed activity after surgery
time frame: 7days after surgery
arm group label: group S
arm group type: Active Comparator
description: Patients were attach with PCA containing 100ml combination of sulfentanyl 2.5ug/kg and flubiprofen axetil 100mg after receiving the loading dose of sulfentanyl 5 ug and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .
arm group label: group N1
arm group type: Experimental
description: Patients were attach with PCA containing 100ml combination of nalbuphine 1.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .
arm group label: group N2
arm group type: Experimental
description: Patients were attach with PCA containing 100ml combination of nalbuphine 2mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .
arm group label: group N3
arm group type: Experimental
description: Patients were attach with PCA containing 100ml combination of nalbuphine 2.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .
arm group label: Group ESRD
arm group type: Other
description: 30 patients with ESRD who underwent PD catheter placement using left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block from our center. The TAP and RS blocks were respectively conducted with 15 ml of 0.5% ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity was evaluated by verbal rating scale (VRS), and the degree of patient and surgeon satisfaction was qualified by a categorical scale.
intervention type: Drug
intervention name: Sulfentanyl
arm group label: group S
other name: sulfentanil
intervention type: Drug
intervention name: Nalbuphine
arm group label: group N1
arm group label: group N2
arm group label: group N3
intervention type: Drug
intervention name: flubiprofen axetil
arm group label: group N1
arm group label: group N2
arm group label: group N3
arm group label: group S
intervention type: Procedure
intervention name: rectus sheath block
description: Transversus abdominis plane (TAP) block combined with rectus sheath (RS) block will be applied in Group ESRD
arm group label: Group ESRD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xuesheng Liu, Doctor
role: Study Director
affiliation: The First Affiliated Hospital of Anhui Medical University
last name: Yu Mao, postgraduate
phone: +86 18019951656
email: maoyu163flying@163.com
last name: Erwei Gu, bachelor
phone: +8613966663478
email: ay_guew_mz@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.
PMID: 24993433
citation: Zeng Z, Lu J, Shu C, Chen Y, Guo T, Wu QP, Yao SL, Yin P. A comparision of nalbuphine with morphine for analgesic effects and safety : meta-analysis of randomized controlled trials. Sci Rep. 2015 Jun 3;5:10927. doi: 10.1038/srep10927.
PMID: 26039709
citation: Kartalov A, Jankulovski N, Kuzmanovska B, Zdravkovska M, Shosholcheva M, Spirovska T, Petrusheva AP, Tolevska M, Srceva M, Durnev V, Jota G, Selmani R, Sivevski A. Effect of Adding Dexamethasone as a Ropivacaine Adjuvant in Ultrasound-Guided Transversus Abdominis Plane Block for Inguinal Hernia Repair. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):35-41. doi: 10.1515/prilozi-2015-0076.
PMID: 27442394
citation: Huang D, Ma X, Zhou D. [Effects of postoperative analgesia of ultrasound-guided transversus abdominis plane block in hemicolectomy patients]. Zhonghua Yi Xue Za Zhi. 2014 Jun 3;94(21):1623-6. Chinese.
PMID: 25152283
citation: Akshat S, Ramachandran R, Rewari V, Chandralekha, Trikha A, Sinha R. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial. Pain Res Treat. 2014;2014:727952. doi: 10.1155/2014/727952. Epub 2014 Apr 14.
PMID: 24834352
responsible party type: Sponsor
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Flurbiprofen
mesh term: Sufentanil
mesh term: Nalbuphine
mesh term: Dsuvia
sharing ipd: No