NCT05565365

Brief Summary

Uncontrolled postoperative pain after inguinal hernia repair increases the incidence of postoperative complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

First Submitted

Initial submission to the registry

September 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

September 30, 2022

Last Update Submit

March 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The intensity of postoperative pain

    Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)

    24 hours after surgery

Study Arms (2)

Transversalis fascia plane (TFP) block

PLACEBO COMPARATOR

Patients will receive unilateral US-TFP block with bupivacaine 15 minutes before skin incision

Procedure: Transversalis fascia plane (TFP) block

Erector Spinae Plane (ESP) Block

ACTIVE COMPARATOR

Patients will receive unilateral US-ESP block with bupivacaine 15 minutes before skin incision

Procedure: Erector Spinae Plane (ESP) Block

Interventions

Patients will receive unilateral US-ESP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision

Also known as: ESP Block
Erector Spinae Plane (ESP) Block

Patients will receive unilateral US-TFP block with 0.3 mL/kg bupivacaine 0.25% 15 minutes before skin incision

Also known as: TFP block
Transversalis fascia plane (TFP) block

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients undergoing elective open unilateral inguinal hernia repair under general anesthesia, ASA status I-II, aged from 20 to 65 years old

You may not qualify if:

  • Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
  • Altered cognitive function
  • Body mass index (BMI \> 35 kg/m2)
  • Patients who have difficulty understanding the study protocol
  • Patients who have any known allergy to study medications
  • Advanced hepatic or renal failure
  • Chronic opioid consumption
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental OcclusionParapsychology

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaBehavioral SciencesBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 4, 2022

Study Start

December 1, 2022

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations