Comparison of Analgesia Efficacy of Transversus Abdominis Plane Block and Posterior Approach Quadratus Lumborum Block
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2022
CompletedStudy Start
First participant enrolled
February 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedApril 26, 2024
April 1, 2024
1.3 years
January 24, 2022
April 24, 2024
Conditions
Keywords
Outcome Measures
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
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.
24 hours postoperatively
Study Arms (2)
transversus abdominis plane block
ACTIVE COMPARATORThe group that underwent bilateral transversus abdominis plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations
quadratus lumborum plane block
ACTIVE COMPARATORThe group that underwent bilateral quadratus lumborum plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations
Interventions
2 different plan blocks; 1. transversus plane block 2. quadratus lumborum plane block
Eligibility Criteria
You may qualify if:
- ASA I-II-II patients who can adapt to the pain assessment scale will be included in the study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mugla Sitki Kocman Training and Research Hospital
Muğla, 48000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Postoperative follow-up was evaluated by a research assistant blind to the procedure. groups 1 and 2 were presented to the Outcome Assessor.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist
Study Record Dates
First Submitted
January 24, 2022
First Posted
October 10, 2023
Study Start
February 5, 2022
Primary Completion
May 21, 2023
Study Completion
June 21, 2023
Last Updated
April 26, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
Only the IPD (after the unidentification of the patients) will be available by correspondence author e-mail.