Comparison of Analgesia Efficacy of Transversus Abdominis Plane Block and Posterior Approach Quadratus Lumborum Block

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Completed
CT.gov ID
NCT06075498
Collaborator
(none)
28
1
2
16.5
1.7

Study Details

Study Description

Brief Summary

Prostate cancer is the second most common cancer and the fifth in cancer-related deaths. Open radical retropubic prostatectomy is the most common surgical treatment for localized prostate cancer. Open radical retropubic prostatectomy is associated with moderate pain. Severe pain in the postoperative period affects the length of hospital stay and morbidity. Multimodal analgesia applications for the management of postoperative pain are the main component of post-surgical recovery. Different analgesia modalities, including systemic opioid use and neuraxial analgesia, have been used for pain control after retropubic radical prostatectomy. Side effects of systemic and intrathecal opioids limit the potential benefits of these agents. Transversus abdominis plane block and quadratus lumborum block are blocks that can be used for postoperative analgesia in the abdominal and pelvic regions. There is no study in the literature comparing the efficacy of these two blocks for postoperative analgesia in open radical retropubic prostatectomy and their effects on narcotic consumption.

Condition or Disease Intervention/Treatment Phase
  • Procedure: transversus abdominis plane block,
N/A

Detailed Description

Scope: Open radical retropubic prostatectomy operation is associated with moderate postoperative pain and affects hospital stay and morbidity. Nerve blocks used for postoperative analgesia are one of the components of multimodal analgesia.

Transversus abdominis plane block (TAP) is a regional block (T7-L1) that blocks the sensory afferents of the anterior abdominal wall. It was first introduced as an anatomical landmark-based technique through Petit's lumbar triangle. Since then, the ultrasound-guided block technique has been defined and the effectiveness of this block in postoperative pain control in abdominal and gynecological surgeries has been demonstrated. The sensory distribution of TAP block includes the incisional pain of open prostatectomy. TAP block technique has been shown to be a safe and effective method of postoperative analgesia in various general surgery, urological surgery, plastic surgery and pediatric surgery operations. In addition, postoperative pain management after lower abdominal surgeries has been recommended as part of ERAS protocols.

Quadratus lumborum block (QL) is used as one of the postoperative pain methods after abdominal surgery in all age groups. It has been reported that QL block with a posterior approach extends more easily into the thoracic paravertebral space or the thoracolumbar plane and can create analgesia from T 7 to L 1. The use of posterior QL (QL-2) blocks for postoperative analgesia after open retropubic prostatectomy operations has not been studied before and it is not known which one is superior.

The primary aim of this study was to compare the analgesic efficacy of transversus abdominis plane block and posterior approach quadratus lumborum block and opioid consumption within 24 hours postoperatively. The secondary aim is to determine whether there is a difference in terms of time to first analgesic consumption, duration of sensory block, opioid-related side effects (postoperative nausea and vomiting, itching, sedation), patient satisfaction, and complications related to the block.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
patients who underwent open retropubic prostatectomypatients who underwent open retropubic prostatectomy
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Postoperative follow-up was evaluated by a research assistant blind to the procedure. groups 1 and 2 were presented to the Outcome Assessor.
Primary Purpose:
Prevention
Official Title:
Comparison of Analgesia Efficacy of Transversus Abdominis Plane Block and Posterior Approach Quadratus Lumborum Block After Open Radical Retropubic Prostatectomy Operation
Actual Study Start Date :
Feb 5, 2022
Actual Primary Completion Date :
May 21, 2023
Actual Study Completion Date :
Jun 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: transversus abdominis plane block

The group that underwent bilateral transversus abdominis plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations

Procedure: transversus abdominis plane block,
2 different plan blocks; 1. transversus plane block 2. quadratus lumborum plane block
Other Names:
  • quadratus lumborum plane block
  • Active Comparator: quadratus lumborum plane block

    The group that underwent bilateral quadratus lumborum plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations

    Procedure: transversus abdominis plane block,
    2 different plan blocks; 1. transversus plane block 2. quadratus lumborum plane block
    Other Names:
  • quadratus lumborum plane block
  • Outcome Measures

    Primary Outcome Measures

    1. To compare the two groups analgesic efficacy and opioid consumption within 24 hours postoperatively. [24 hours postoperatively]

      To compare the analgesic efficacy of transversus abdominis plane block and posterior approach quadratus lumborum block and opioid consumption within 24 hours postoperatively.

    Secondary Outcome Measures

    1. Duration of sensory block, opioid-related side effects (postoperative nausea and vomiting, itching, sedation), patient satisfaction and complications related to the block. [24 hours postoperatively]

      To determine whether there is a difference in terms of time until the first analgesic consumption, duration of sensory block, opioid-related side effects (postoperative nausea and vomiting, itching, sedation), patient satisfaction and complications related to the block.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ASA I-II-II patients who can adapt to the pain assessment scale will be included in the study.
    Exclusion Criteria:
    • Patients under 18 years of age

    • ASA IV patients

    • patients with known allergy to analgesic drugs

    • patients with any contraindications for the regional technique (patients with coagulation disorders, injection site infection, patients allergic to local anesthetics)

    • patients with chronic analgesic use

    • body mass patients with an index over 35 kg/m2

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mugla Sitki Kocman University Mugla Turkey 48000

    Sponsors and Collaborators

    • Muğla Sıtkı Koçman University

    Investigators

    • Study Chair: basak altiparmak, Mugla Sitki Kocman University Department of Anesthesia
    • Study Chair: ahmet pinarbasi, Mugla Sitki Kocman University Department of Anesthesia
    • Study Chair: ilker akarken, Mugla sitki kocman department of urology
    • Study Chair: bakiye ugur, Mugla Sitki Kocman Universty of Anaesthesia
    • Principal Investigator: eylem yasar, Mugla Sitkı Kocman Training and research hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eylem Yaşar, Specialist, Muğla Sıtkı Koçman University
    ClinicalTrials.gov Identifier:
    NCT06075498
    Other Study ID Numbers:
    • 22/III
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eylem Yaşar, Specialist, Muğla Sıtkı Koçman University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 10, 2023