CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
US guided five step field block +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03193723
NCT03193723N/ACompleted

Efficacy of Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) as a Sole Anesthetic for Open Inguinal Hernia Repair Versus Spinal Anesthesia: A Randomized Controlled Study.

Eslam Ayman Mohamed Shawki·interventional·Posted Jun 21, 2017·Updated Oct 4, 2018

In Brief

A clinical study evaluating US guided five step field block and Spinal anesthesia for Inguinal Hernia. Completed, enrolled 96 participants across 1 site.

Detailed Summary

The aim of this study is to evaluate success, efficacy, feasibility and safety of a simple five step ultrasound guided local anesthetic infiltration technique for unilateral open inguinal hernia repair and to determine the non-inferiority of the block to spinal anesthesia by comparing intraoperative and postoperative complications, pain control and patient and surgeon satisfaction of the block with spinal anesthesia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInguinal Hernia
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 21, 2017
Enrollment StartOct 1, 2016
Primary CompletionJul 1, 2018
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.0 years ago

Interventions

US guided five step field blockprocedure

Ultrasound will guide needle insertion in the following layers (except intradermic injection): * Subdermic infiltration. Approximately 8 milliliters * Intradermic injection (making of the skin wheal). of approximately 6 milliliters. * Deep subcutaneous injection. 8 milliliters of the mixture will be injected deep into the subcutaneous adipose * Subfascial infiltration. Approximately eight milliliters of the anesthetic mixture will be injected immediately underneath the aponeurosis of the external oblique. * Pubic tubercle and hernia sac injection. Occasionally, infiltration of ten milliliters of the mixture at the level of the pubic tubercle, around the neck and inside the indirect hernia sac

Spinal anesthesiaprocedure

Spinal anesthesia will be administered in sitting position, with 25 gauge Quincke spinal needle in L3-L4 intervertebral space, under all aseptic precautions and local infiltration, with 3.0 ml of 0.5% bupivacaine (heavy) after ensuring free, clear and adequate flow of cerebrospinal fluid. After giving spinal anesthesia, patient will be made to lie supine.