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/NCT06028100</url>
    </required_header>
    <id_info>
      <org_study_id>2023/06</org_study_id>
      <nct_id>NCT06028100</nct_id>
    </id_info>
    <brief_title>Sacral Erector Spinae Plane Block(ESPB) in Lumbar Discectomy</brief_title>
    <acronym>ESPB</acronym>
    <official_title>The Effect of an Ultrasound-guided Sacral Erector Spinae Plane Block on the Post-operative Pain of Lumbar Discectomy Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bilge Olgun Keles</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Giresun University</source>
    <oversight_info>
      <has_dmc>No</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>
        Several studies have shown that sacral espb blocks the dorsal ramus of spinal nerves. In&#xD;
        lumbar discectomy operations, innervation of all tissues where pain occurs is provided by the&#xD;
        dorsal ramus of the nerves. Based on this information, it was thought that sacral espb would&#xD;
        be effective in lumbar discectomies. The investigators wanted to look at the effects of&#xD;
        sacral erector spinae plane block on postoperative pain and opioid consumption in lumbar&#xD;
        discectomy operations. There is no randomised controlled study on sacral espb in the&#xD;
        literature. The researchers think that the results of the study are promising. Sacral espb is&#xD;
        an easy-to-administer block with a low risk of complications and can be used effectively in&#xD;
        lumbar discectomy analgesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This prospective, randomised, controlled, double-blind, single-centre study was approved by&#xD;
        our Ethics Committee (KAEK2023/06). The investigators followed the Consolidated Reporting&#xD;
        Trials Standards (CONSORT). It was conducted in patients undergoing elective lumbar&#xD;
        discectomy, and informed consent was obtained from the patients. They were randomised using a&#xD;
        closed envelope technique, opened by the physician performing the block. 54 patients were&#xD;
        included in the study, divided into two groups of 27 patients as esp block (group 1) and&#xD;
        control group (group 2), both groups underwent standard general anaesthesia. The blocks were&#xD;
        performed in the operating theatre at the end of the operation, before the patient woke up.&#xD;
        The patients were unaware that the block was being performed on them. A patient-controlled&#xD;
        analgesia (PCA) device was given to both groups by another doctor blinded to the group, and&#xD;
        Visual Analogue Scale (VAS) scores assessed for 24 hours.&#xD;
  &#xD;
        Standard monitoring (peripheral oxygen saturation, electrocardiogram, non-invasive arterial&#xD;
        blood pressure monitoring) was performed. Anaesthesia induction was achieved with 1 mcg/kg&#xD;
        fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium, and anaesthesia maintenance with 2%&#xD;
        sevoflurane, 4 lt/min 50%/50% oxygen/nitrogen mixture. Both groups received 1 g IV&#xD;
        paracetamol towards the end of surgery. The patients were extubated after 2 mg/kg of&#xD;
        sugammadex and were transferred to the recovery room.&#xD;
  &#xD;
        The first group underwent sacral espb at the end of surgery. The lumbosacral region was&#xD;
        sterilised with povidine iodine and then draped with the patient in prone position. The&#xD;
        linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar&#xD;
        vertebra after the sterile covering had been applied. After observation of the sacrum, the&#xD;
        level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm&#xD;
        laterally and the 2nd intermediate crest and the erector spinae muscle between the two were&#xD;
        observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest&#xD;
        using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25%&#xD;
        bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially&#xD;
        separating the erector spinae muscle from the sacral crest, the same procedure was performed&#xD;
        on the opposite side.&#xD;
  &#xD;
        All patient demographics, age, weight, and duration of surgery, post-operative VAS scores,&#xD;
        blood pressure, heart rate and oxygen saturation values at 30 min, 1, 6, 12 and 24 hours,&#xD;
        total tramadol consumption, rescue analgesic use, time of first rescue analgesic requirement,&#xD;
        patient satisfaction and side effects were recorded.&#xD;
  &#xD;
        The Shapiro-Wilk test was used to examine the normality of quantitative data. Comparison of&#xD;
        normally distributed data was performed by independent samples t-test, and comparison of&#xD;
        non-normally distributed data was performed by Mann-Whitney U test. Comparison of qualitative&#xD;
        data was performed using the Pearson chi-squared test. Data were presented as mean ± standard&#xD;
        deviation, median (minimum - maximum) and n (%). Statistical significance was accepted as&#xD;
        p&lt;0.05. In a previous study (9), the power analysis performed to detect a difference of 15.4&#xD;
        mg between the 48-hour opioid consumption values of the two groups (p&lt;0.05) was calculated&#xD;
        with 90% power and an effect size of 0.96, and the required sample size was determined to be&#xD;
        24 for each group. If 10-15% of patients were excluded from the study, 27 patients were&#xD;
        included for each group and 54 patients in total.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Actual">August 30, 2023</completion_date>
    <primary_completion_date type="Actual">July 30, 2023</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>54 patients were included in the study, divided into two groups of 27 patients as esp block (group 1) and control group (group 2), both groups underwent standard general anaesthesia. The blocks were performed in the operating theatre at the end of the operation, before the patient woke up.A patient-controlled analgesia (PCA) device was given to both groups by another doctor blinded to the group, and Visual Analogue Scale (VAS) scores assessed for 24 hours.And total consumption of analgesic and rescue analgesics were recorded.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The patient did not know what was done to him/her because the block was performed before the patient woke up.&#xD;
  The investigator who questioned postoperative pain and opioid consumption did not know to whom the block was performed.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Patient pain scores</measure>
      <time_frame>24 hours</time_frame>
      <description>Visual Analog Scala (0:No pain 10: Worst pain possible)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient total opioid consumption</measure>
      <time_frame>24 hours</time_frame>
      <description>The number of patient controlled analgesia device boluses doses</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nausea-vomiting</measure>
      <time_frame>24 hours</time_frame>
      <description>The incidence of side effects described yes or no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>24. hours</time_frame>
      <description>Patient satisfaction (0:Not satisfied 10:Very satisfied)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">54</enrollment>
    <condition>Pain Management</condition>
    <arm_group>
      <arm_group_label>espb group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The first group underwent sacral espb at the end of surgery. The lumbosacral region was sterilised with povidine iodine and then draped with the patient in prone position. The linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar vertebra after the sterile covering had been applied. After observation of the sacrum, the level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm laterally and the 2nd intermediate crest and the erector spinae muscle between the two were observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25% bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially separating the erector spinae muscle from the sacral crest, the same procedure was performed on the opposite side</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The second group had no any block</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>sacral erector spinae plane block</intervention_name>
      <description>espb from bilateral sacral level 2 with 20 ml %0,25 bupivacaine</description>
      <arm_group_label>espb group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients over 18 years of age,&#xD;
  &#xD;
            -  American Society of Anesthesiology(ASA) status 1-3 group&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who refused to participate in the study&#xD;
  &#xD;
            -  Patients with known neuromuscular and haematological diseases&#xD;
  &#xD;
            -  Allergy to local anaesthetics&#xD;
  &#xD;
            -  Contraindications to regional anaesthesia&#xD;
  &#xD;
            -  Anatomical changes in the lumbo-sacral region&#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>Bilge Olgun Keleş, M.D.</last_name>
      <role>Study Director</role>
      <affiliation>Giresun University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Giresun Research and Training Hospital</name>
        <address>
          <city>Merkez</city>
          <state>Giresun</state>
          <zip>28100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.</citation>
      <PMID>30853517</PMID>
    </results_reference>
    <results_reference>
      <citation>Bajwa SJ, Haldar R. Pain management following spinal surgeries: An appraisal of the available options. J Craniovertebr Junction Spine. 2015 Jul-Sep;6(3):105-10. doi: 10.4103/0974-8237.161589.</citation>
      <PMID>26288544</PMID>
    </results_reference>
    <results_reference>
      <citation>Kilicaslan A, Aydin A, Kekec AF, Ahiskalioglu A. Sacral erector spinae plane block provides effective postoperative analgesia for pelvic and sacral fracture surgery. J Clin Anesth. 2020 May;61:109674. doi: 10.1016/j.jclinane.2019.109674. Epub 2019 Dec 4. No abstract available.</citation>
      <PMID>31812367</PMID>
    </results_reference>
    <results_reference>
      <citation>Chakraborty A, Chakraborty S, Sen S, Bhatacharya T, Khemka R. Modification of the sacral erector spinae plane block using an ultrasound-guided sacral foramen injection: dermatomal distribution and radiocontrast study. Anaesthesia. 2021 Nov;76(11):1538-1539. doi: 10.1111/anae.15549. Epub 2021 Jul 26. No abstract available.</citation>
      <PMID>34309009</PMID>
    </results_reference>
    <results_reference>
      <citation>Mistry T, Sonawane K, Balasubramanian S, Balavenkatasubramanian J, Goel VK. Ultrasound-guided sacral multifidus plane block for sacral spine surgery: A case report. Saudi J Anaesth. 2022 Apr-Jun;16(2):236-239. doi: 10.4103/sja.sja_723_21. Epub 2022 Mar 17.</citation>
      <PMID>35431750</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Giresun University</investigator_affiliation>
      <investigator_full_name>Bilge Olgun Keles</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <keyword>regional block</keyword>
    <keyword>erector spinae plane block</keyword>
    <keyword>pain management</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Since it is the first study on this subject in the literature</ipd_description>
    </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/NCT06028100
  org study id: 2023/06
  nct id: NCT06028100
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Several studies have shown that sacral espb blocks the dorsal ramus of spinal nerves. In
        lumbar discectomy operations, innervation of all tissues where pain occurs is provided by the
        dorsal ramus of the nerves. Based on this information, it was thought that sacral espb would
        be effective in lumbar discectomies. The investigators wanted to look at the effects of
        sacral erector spinae plane block on postoperative pain and opioid consumption in lumbar
        discectomy operations. There is no randomised controlled study on sacral espb in the
        literature. The researchers think that the results of the study are promising. Sacral espb is
        an easy-to-administer block with a low risk of complications and can be used effectively in
        lumbar discectomy analgesia.
  This prospective, randomised, controlled, double-blind, single-centre study was approved by
        our Ethics Committee (KAEK2023/06). The investigators followed the Consolidated Reporting
        Trials Standards (CONSORT). It was conducted in patients undergoing elective lumbar
        discectomy, and informed consent was obtained from the patients. They were randomised using a
        closed envelope technique, opened by the physician performing the block. 54 patients were
        included in the study, divided into two groups of 27 patients as esp block (group 1) and
        control group (group 2), both groups underwent standard general anaesthesia. The blocks were
        performed in the operating theatre at the end of the operation, before the patient woke up.
        The patients were unaware that the block was being performed on them. A patient-controlled
        analgesia (PCA) device was given to both groups by another doctor blinded to the group, and
        Visual Analogue Scale (VAS) scores assessed for 24 hours.
  
        Standard monitoring (peripheral oxygen saturation, electrocardiogram, non-invasive arterial
        blood pressure monitoring) was performed. Anaesthesia induction was achieved with 1 mcg/kg
        fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium, and anaesthesia maintenance with 2%
        sevoflurane, 4 lt/min 50%/50% oxygen/nitrogen mixture. Both groups received 1 g IV
        paracetamol towards the end of surgery. The patients were extubated after 2 mg/kg of
        sugammadex and were transferred to the recovery room.
  
        The first group underwent sacral espb at the end of surgery. The lumbosacral region was
        sterilised with povidine iodine and then draped with the patient in prone position. The
        linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar
        vertebra after the sterile covering had been applied. After observation of the sacrum, the
        level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm
        laterally and the 2nd intermediate crest and the erector spinae muscle between the two were
        observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest
        using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25%
        bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially
        separating the erector spinae muscle from the sacral crest, the same procedure was performed
        on the opposite side.
  
        All patient demographics, age, weight, and duration of surgery, post-operative VAS scores,
        blood pressure, heart rate and oxygen saturation values at 30 min, 1, 6, 12 and 24 hours,
        total tramadol consumption, rescue analgesic use, time of first rescue analgesic requirement,
        patient satisfaction and side effects were recorded.
  
        The Shapiro-Wilk test was used to examine the normality of quantitative data. Comparison of
        normally distributed data was performed by independent samples t-test, and comparison of
        non-normally distributed data was performed by Mann-Whitney U test. Comparison of qualitative
        data was performed using the Pearson chi-squared test. Data were presented as mean ± standard
        deviation, median (minimum - maximum) and n (%). Statistical significance was accepted as
        p<0.05. In a previous study (9), the power analysis performed to detect a difference of 15.4
        mg between the 48-hour opioid consumption values of the two groups (p<0.05) was calculated
        with 90% power and an effect size of 0.96, and the required sample size was determined to be
        24 for each group. If 10-15% of patients were excluded from the study, 27 patients were
        included for each group and 54 patients in total.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 54 patients were included in the study, divided into two groups of 27 patients as esp block (group 1) and control group (group 2), both groups underwent standard general anaesthesia. The blocks were performed in the operating theatre at the end of the operation, before the patient woke up.A patient-controlled analgesia (PCA) device was given to both groups by another doctor blinded to the group, and Visual Analogue Scale (VAS) scores assessed for 24 hours.And total consumption of analgesic and rescue analgesics were recorded.
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  masking description: The patient did not know what was done to him/her because the block was performed before the patient woke up.
  The investigator who questioned postoperative pain and opioid consumption did not know to whom the block was performed.
  measure: Patient pain scores
  time frame: 24 hours
  description: Visual Analog Scala (0:No pain 10: Worst pain possible)
  measure: Patient total opioid consumption
  time frame: 24 hours
  description: The number of patient controlled analgesia device boluses doses
  measure: Nausea-vomiting
  time frame: 24 hours
  description: The incidence of side effects described yes or no
  measure: Patient satisfaction
  time frame: 24. hours
  description: Patient satisfaction (0:Not satisfied 10:Very satisfied)
  arm group label: espb group
  arm group type: Active Comparator
  description: The first group underwent sacral espb at the end of surgery. The lumbosacral region was sterilised with povidine iodine and then draped with the patient in prone position. The linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar vertebra after the sterile covering had been applied. After observation of the sacrum, the level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm laterally and the 2nd intermediate crest and the erector spinae muscle between the two were observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25% bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially separating the erector spinae muscle from the sacral crest, the same procedure was performed on the opposite side
  arm group label: control group
  arm group type: No Intervention
  description: The second group had no any block
  intervention type: Procedure
  intervention name: sacral erector spinae plane block
  description: espb from bilateral sacral level 2 with 20 ml %0,25 bupivacaine
  arm group label: espb group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bilge Olgun Keleş, M.D.
  role: Study Director
  affiliation: Giresun University
  facility: 
  country: Turkey
  citation: Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.
  PMID: 30853517
  citation: Bajwa SJ, Haldar R. Pain management following spinal surgeries: An appraisal of the available options. J Craniovertebr Junction Spine. 2015 Jul-Sep;6(3):105-10. doi: 10.4103/0974-8237.161589.
  PMID: 26288544
  citation: Kilicaslan A, Aydin A, Kekec AF, Ahiskalioglu A. Sacral erector spinae plane block provides effective postoperative analgesia for pelvic and sacral fracture surgery. J Clin Anesth. 2020 May;61:109674. doi: 10.1016/j.jclinane.2019.109674. Epub 2019 Dec 4. No abstract available.
  PMID: 31812367
  citation: Chakraborty A, Chakraborty S, Sen S, Bhatacharya T, Khemka R. Modification of the sacral erector spinae plane block using an ultrasound-guided sacral foramen injection: dermatomal distribution and radiocontrast study. Anaesthesia. 2021 Nov;76(11):1538-1539. doi: 10.1111/anae.15549. Epub 2021 Jul 26. No abstract available.
  PMID: 34309009
  citation: Mistry T, Sonawane K, Balasubramanian S, Balavenkatasubramanian J, Goel VK. Ultrasound-guided sacral multifidus plane block for sacral spine surgery: A case report. Saudi J Anaesth. 2022 Apr-Jun;16(2):236-239. doi: 10.4103/sja.sja_723_21. Epub 2022 Mar 17.
  PMID: 35431750
  responsible party type: Sponsor-Investigator
  investigator affiliation: Giresun University
  investigator full name: Bilge Olgun Keles
  investigator title: Assistant professor
  sharing ipd: No
  ipd description: Since it is the first study on this subject in the literature