NCT06997536

Brief Summary

Inguinal hernia is a common condition, particularly among male patients, and represents one of the most frequent indications for lower abdominal surgeries. Postoperative acute pain and, more importantly, the progression of acute pain into chronic pain, remain significant challenges in the postoperative period. Effective postoperative pain management is therefore crucial in inguinal hernia repair. In addition to systemic analgesia, various regional anesthesia techniques are employed in this setting. In recent years, peripheral nerve blocks such as the ilioinguinal-iliohypogastric (IL/IH) block, transversus abdominis plane (TAP) block, and quadratus lumborum block (QLB) have gained popularity for postoperative analgesia. These techniques offer several advantages, including reduced opioid consumption and decreased need for additional analgesics, while also minimizing hemodynamic instability and facilitating early mobilization. The IL/IH block is performed by injecting a local anesthetic into the fascial plane between the transversus abdominis and internal oblique muscles, targeting the ilioinguinal and iliohypogastric nerves, which are branches of the L1 spinal nerve. The TAP block, first described by Rafi in 2001, involves injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles within the Petit triangle, where the T6-T11 spinal nerve branches responsible for abdominal wall innervation are located. The quadratus lumborum block (QLB) was initially described by Blanco. The first version, known as QLB1, involves posterior injection of local anesthetic lateral to the quadratus lumborum muscle. In 2013, Jens Børglum introduced the transmuscular variant (QLB3), where the local anesthetic is administered between the quadratus lumborum and psoas muscles. In this study, we aimed to compare postoperative outcomes in patients undergoing inguinal hernia repair under spinal anesthesia, with and without additional peripheral nerve blocks (IL/IH block, TAP block, and QLB). Specifically, we evaluated pain levels using the Visual Analog Scale (VAS) at the 30th minute, 2nd, 6th, 12th, and 24th hours postoperatively. We also assessed opioid-related side effects such as nausea and vomiting associated with patient-controlled analgesia (PCA) using tramadol, the total bolus and infusion doses of tramadol administered, and the amount of additional analgesia in the form of paracetamol. These outcomes were compared among the different block groups and with a control group that received only spinal anesthesia without any additional block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 28, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 21, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

Inguinal herniaIlioinguinal-iliohypogastric blockTransversus abdominis plane blockQuadratus lumborum block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Score

    Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (the worst imaginable pain). Pain scores will be recorded at predefined time points during rest and movement.

    Postoperative 30th minute, 2nd, 6th, 12th and 24th hours

Secondary Outcomes (1)

  • Total Opioid Consumption at 24 Hours.

    At the end of the 24th hour

Other Outcomes (2)

  • Total nausea and vomiting count over 24 hours

    At the end of the 24th hour

  • Need for additional analgesia

    At the end of the 24th hour

Study Arms (4)

Ilioinguinal/Iliohypogastric Block

EXPERIMENTAL

After spinal anesthesia was applied, a preoperative ilioinguinal/iliohypogastric block was administered to the side to be operated on.

Procedure: Ilioinguinal/iliohypogastric Nerve Block

Transversus abdominis plane (TAP) block

EXPERIMENTAL

After spinal anesthesia was applied, a preoperative transversus abdominis plane (TAP) block was administered to the side to be operated on.

Procedure: Transversus abdominis plane (TAP) block

Quadratus Lumborum Block

EXPERIMENTAL

After spinal anesthesia was applied, a preoperative quadratus lumborum block (QLB) was administered to the side to be operated on.

Procedure: Quadratus Lumborum Block (QLB)

Control

NO INTERVENTION

No block was applied after spinal anesthesia.

Interventions

The aim of this study is to compare the analgesic efficacy of IL/IH block, TAP block, and QLB applied in inguinal hernia cases operated under spinal anesthesia, with each other and with a control group that did not receive any additional block to spinal anesthesia.

Ilioinguinal/Iliohypogastric Block

The aim of this study is to compare the analgesic efficacy of IL/IH block, TAP block, and QLB applied in inguinal hernia cases operated under spinal anesthesia, with each other and with a control group that did not receive any additional block to spinal anesthesia.

Transversus abdominis plane (TAP) block

The aim of this study is to compare the analgesic efficacy of IL/IH block, TAP block, and QLB applied in inguinal hernia cases operated under spinal anesthesia, with each other and with a control group that did not receive any additional block to spinal anesthesia.

Quadratus Lumborum Block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients classified as ASA I and II
  • Patients aged 18 to 75 years
  • Patients undergoing unilateral inguinal hernia surgery under spinal anesthesia

You may not qualify if:

  • Patients with preoperative neurological sequelae
  • Patients with a BMI \>30
  • Patients who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namik Kemal University

Tekirdağ, 59020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, InguinalBites and Stings

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

June 28, 2022

Primary Completion

June 28, 2023

Study Completion

May 1, 2024

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations