NCT06812741

Brief Summary

Comparing Postop Analgesia after Inguinal Hernia Surgery treated with TAP Block Vs Ilioinguinal/ Iliohypogastric Nerve Block

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2024

Shorter than P25 for phase_3

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

February 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 28, 2025

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

February 2, 2025

Last Update Submit

February 25, 2025

Conditions

Keywords

postop analgesiapostoperative analgesiaTAP blocktransversus abdominis plane blockilioinguinal/ iliohypogastric nerve blockilioinguinal/iliohypogastric nerve blockinguinal hernia surgeryabdominal nerve blocknerve blocknerve blocksbupivacaineultrasound guided nerve blockultrasound guided nerve blocks0.25% bupivacaine0.25 percent bupivacainehernioplastyinternal obliquetransversus abdominisIINIHNIIN/ IHNII/ IH nerve blocktransversus abdominis muscleilioinguinal muscleiliohypogastric muscle

Outcome Measures

Primary Outcomes (1)

  • Mean duration of Postoperative Analgesia

    The study was conducted to compare the mean duration of postoperative analgesia in patients undergoing inguinal hernia repair surgery treated with transversus abdominis plane block versus the mean duration of postoperative analgesia in patients undergoing inguinal hernia repair surgery treated with ilioinguinal and iliohypogastric nerve block.

    6 months

Study Arms (2)

Inguinal Hernia Surgery (Group T)

EXPERIMENTAL

Half of the study participants named Group T were administered Ultrasound Guided Transversus Abdominis Plane Nerve Block and the other half named Group I were administered Ilioinguinal \& Iliohypogastric Nerve Block before the Inguinal Hernia Surgery.

Drug: Transversus abdominis plane (TAP) block with 0.25 % bupivacaine

Inguinal Hernia Surgery (Group I)

EXPERIMENTAL

Half of the study participants named Group T were administered Ultrasound Guided Transversus Abdominis Plane Nerve Block and the other half named Group I were administered Ilioinguinal \& Iliohypogastric Nerve Block before the Inguinal Hernia Surgery.

Drug: Ilioinguinal/iliohypogastric Nerve Block with 0.25 % bupivacaine

Interventions

The probe was placed in a plane transverse to the lateral abdominal wall in the mid-axillary line immediately cephalad to the iliac crest. The needle was advanced immediately anterior to the probe using the in-plane needle-probe orientation and advanced posteriorly until the needle was observed to penetrate the interface between the internal oblique and transversus abdominis muscles. Thereafter, a local anesthetic (0.2 mL/kg of 0.25 % bupivacaine) was injected incrementally, and the spread was observed within the plane.

Inguinal Hernia Surgery (Group T)

The ultrasound probe was placed immediately medial and slightly cephalad to the upper aspect of the anterior superior iliac spine to obtain a short-axis view of the nerves situated between the two abdominal muscles (internal oblique and transversus abdominis), A 22 G needle tip \~1 cm caudal to the probe surface was introduced and was advanced until a characteristic 'tenting' of the interface between the two muscles was seen and was then further advanced deep to this interface until a pop was felt and then the injectate (0.2 mL/kg of 0.25 % bupivacaine) was observed spreading between these two layers.

Inguinal Hernia Surgery (Group I)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients giving written informed consent
  • Patients undergoing Inguinal Hernia surgery
  • patients with ages 18-60 years
  • ASA 1 and 2 patients

You may not qualify if:

  • INR \> 1.0 (patients with bleeding tendency)
  • EF \< 45 % (patients with cardiac dysfunction)
  • FEV1 \< 80 % of normal (patients with pulmonary dysfunction)
  • patients with renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Military Hospital Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Dental OcclusionBupivacaine

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FCPS Registrar in Anaesthesia

Study Record Dates

First Submitted

February 2, 2025

First Posted

February 6, 2025

Study Start

February 9, 2024

Primary Completion

July 28, 2024

Study Completion

July 28, 2024

Last Updated

February 28, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations