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Not yet recruiting NCT07604259

Comparison of QLB and TFP Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia

No phase Interventional İnguinal Hernia Post Operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lateral Quadratus Lumborum Block, Transversalis Fascia Plane Block, Port Site Infiltration.
Who it may be relevant to
Registry conditions: İnguinal Hernia, Post Operative Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

This randomized controlled trial aims to compare the effects of ultrasound-guided lateral Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP) block on postoperative analgesia in patients undergoing laparoscopic inguinal hernia repair. Ninety patients will be randomly assigned to one of three groups: Group QLB, Group TFP, or Group Control. The primary objective is to compare postoperative pain scores (NRS) at various time points within the first 24 hours. Secondary objectives include evaluating the need for rescue analgesia, total tramadol consumption, and the incidence of opioid-related side effects.

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.

Interventions

  • Procedure Lateral Quadratus Lumborum Block
    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.
  • Procedure Transversalis Fascia Plane Block
    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.
  • Procedure Port Site Infiltration
    Local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites.

Primary outcome measures

  • Numeric Rating Scale (NRS) Pain Score [Time frame: At 0, 3, 6, 12, 18, and 24 hours postoperatively.]
Secondary outcome measures (4)
  • Total Tramadol Consumption [Time frame: During the first 24 hours postoperatively.]
  • Need for Rescue Analgesia [Time frame: During the first 24 hours postoperatively]
  • Incidence of Opioid-Related Side Effects [Time frame: During the first 24 hours postoperatively.]
  • Incidence of Block-Related Complications [Time frame: During the first 24 hours postoperatively.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Medipol University — Istanbul

Identifiers

NCT: NCT07604259 · İnguinal QLB vs TFP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗