- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07604259
Comparison of QLB and TFP Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia
Comparison of the Effects of Ultrasound-Guided Lateral Quadratus Lumborum Block and Transversalis Fascia Plane Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Laparoscopic inguinal hernia repair is a standard, minimally invasive procedure. However, moderate pain is common in the first 24 hours postoperatively, originating from somatic pain at trocar sites and visceral pain from peritoneal irritation and mesh placement. Multimodal analgesia, including fascial plane blocks, is recommended to reduce opioid consumption and improve pain control.
In this prospective, randomized, controlled, single-center trial, 90 patients (ASA I-III, aged 18-65) scheduled for elective laparoscopic inguinal hernia repair under general anesthesia will be allocated into three parallel arms (n=30 each) via computer-based randomization.
Group QLB: Will receive bilateral ultrasound-guided lateral Quadratus Lumborum Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group TFP: Will receive bilateral ultrasound-guided Transversalis Fascia Plane Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group Control: Will receive only port site infiltration (total 20 mL 0.25% bupivacaine).
All procedures will be performed aseptically by the same surgical and anesthesia team. Postoperatively, all patients will receive 1 g intravenous paracetamol every 8 hours. Postoperative pain will be assessed using the Numeric Rating Scale (NRS) by an anesthesiologist blinded to the group allocation. Intravenous tramadol (100 mg) will be administered as rescue analgesia if the NRS score is ≥ 4. Total 24-hour tramadol consumption, along with block-related complications and opioid-related side effects (nausea, vomiting, sedation), will be recorded.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Scheduled for elective laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Age between 18 and 65 years.
- Provided written informed consent.
Exclusion Criteria:
- History of allergy to local anesthetics.
- Presence of coagulopathy.
- Signs of infection at the intended block application site.
- Body Mass Index (BMI) ≥ 35 kg/m².
- History of chronic opioid use.
- Presence of neurological disease.
- Refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group QLB
Patients will receive bilateral lateral Quadratus Lumborum Block (QLB) and port site infiltration at the end of the surgery.
|
Bilateral ultrasound-guided lateral QLB with 20 mL of 0.25% bupivacaine per side (total 40 mL).
Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
|
|
Experimental: Group TFP
Patients will receive bilateral Transversalis Fascia Plane (TFP) block and port site infiltration at the end of the surgery.
|
Bilateral ultrasound-guided TFP block with 20 mL of 0.25% bupivacaine per side (total 40 mL).
Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
|
|
Active Comparator: Group Control
Patients will receive only port site infiltration at the end of the surgery.
|
Local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Score
Time Frame: At 0, 3, 6, 12, 18, and 24 hours postoperatively.
|
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS).
The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain".
Higher scores represent worse pain outcomes.
|
At 0, 3, 6, 12, 18, and 24 hours postoperatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Tramadol Consumption
Time Frame: During the first 24 hours postoperatively.
|
The cumulative dose of intravenous tramadol (in milligrams) administered as rescue analgesia.
|
During the first 24 hours postoperatively.
|
|
Need for Rescue Analgesia
Time Frame: During the first 24 hours postoperatively
|
The number of patients requiring rescue analgesia (tramadol 100 mg IV) when the NRS score is ≥ 4.
|
During the first 24 hours postoperatively
|
|
Incidence of Opioid-Related Side Effects
Time Frame: During the first 24 hours postoperatively.
|
The number of patients experiencing postoperative nausea, vomiting, or sedation.
|
During the first 24 hours postoperatively.
|
|
Incidence of Block-Related Complications
Time Frame: During the first 24 hours postoperatively.
|
The number of patients experiencing complications related to the regional block application, such as hematoma, infection, or local anesthetic systemic toxicity (LAST).
|
During the first 24 hours postoperatively.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- İnguinal QLB vs TFP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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