NCT07604259

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

June 10, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

Laparoscopic inguinal hernia, Quadratus Lumborum Block, Transversalis Fascia Plane Block, Postoperative analgesia, Regional anesthesia.

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale (NRS) Pain Score

    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 Outcomes (4)

  • Total Tramadol Consumption

    During the first 24 hours postoperatively.

  • Need for Rescue Analgesia

    During the first 24 hours postoperatively

  • Incidence of Opioid-Related Side Effects

    During the first 24 hours postoperatively.

  • Incidence of Block-Related Complications

    During the first 24 hours postoperatively.

Study Arms (3)

Group QLB

EXPERIMENTAL

Patients will receive bilateral lateral Quadratus Lumborum Block (QLB) and port site infiltration at the end of the surgery.

Procedure: Lateral Quadratus Lumborum Block

Group TFP

EXPERIMENTAL

Patients will receive bilateral Transversalis Fascia Plane (TFP) block and port site infiltration at the end of the surgery.

Procedure: Transversalis Fascia Plane Block

Group Control

ACTIVE COMPARATOR

Patients will receive only port site infiltration at the end of the surgery.

Procedure: Port Site Infiltration

Interventions

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.

Group QLB

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.

Group TFP

Local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites.

Group Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, InguinalPain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assist. prof.

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start (Estimated)

June 10, 2026

Primary Completion (Estimated)

April 10, 2027

Study Completion (Estimated)

May 10, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations