- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06075498
Comparison of Analgesia Efficacy of Transversus Abdominis Plane Block and Posterior Approach Quadratus Lumborum Block
Comparison of Analgesia Efficacy of Transversus Abdominis Plane Block and Posterior Approach Quadratus Lumborum Block After Open Radical Retropubic Prostatectomy Operation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Mugla, Turkey, 48000
- Mugla Sitki Kocman Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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
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2 different plan blocks; 1. transversus plane block 2. quadratus lumborum plane block
Other Names:
|
|
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
|
2 different plan blocks; 1. transversus plane block 2. quadratus lumborum plane block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the two groups analgesic efficacy and opioid consumption within 24 hours postoperatively.
Time Frame: 24 hours postoperatively
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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
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
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24 hours postoperatively
|
Collaborators and Investigators
Sponsor
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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22/III
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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