CClinicalTrials.gg
CompletedNCT06075498Updated Apr 26, 2024

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

An interventional study of transversus abdominis plane block, in Acute Post-operative Pain, Nerve Block and Prostate Cancer, sponsored by Muğla Sıtkı Koçman University. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Muğla Sıtkı Koçman University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Post-operative Pain
  • Nerve Block
  • Prostate Cancer

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Keywords

  • quadratus lumborum block, transversus abdominis plane block
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 66 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Muğla Sıtkı Koçman University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • 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,

  • 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,

Interventions

  • Proceduretransversus abdominis plane block,

    2 different plan blocks; 1. transversus plane block 2. quadratus lumborum plane block

    Also known as: quadratus lumborum plane block

06

What researchers measure

Primary outcomes

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

    Comparing the analgesic effectiveness of the transversus abdominis plane block and posterior approach quadratus lumborum block and opioid intake and patient pain within 24 hours after surgery

    Time frame: 24 hours postoperatively

Secondary outcomes

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

    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.

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Mugla Sitki Kocman Training and Research Hospital
    Mugla, 48000, Turkey
08

References and documents

Individual participant data

Plan to share: No — Only the IPD (after the unidentification of the patients) will be available by correspondence author e-mail.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06075498
Lead sponsor
Muğla Sıtkı Koçman University
Responsible party
Eylem Yaşar (Specialist, Muğla Sıtkı Koçman University) — Principal investigator
First posted
Oct 10, 2023
Start date
Feb 5, 2022
Primary completion
May 21, 2023
Completion
Jun 21, 2023
Last update
Apr 26, 2024

Study contacts

basak altiparmak
study chair · Mugla Sitki Kocman University Department of Anesthesia
ahmet pinarbasi
study chair · Mugla Sitki Kocman University Department of Anesthesia
ilker akarken
study chair · Mugla sitki kocman department of urology
bakiye ugur
study chair · Mugla Sitki Kocman Universty of Anaesthesia
eylem yasar
principal investigator · Mugla Sitkı Kocman Training and research hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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