Comparison Between Ultra Sound Guided Rectus Sheath Block and Field Block for Midline Hernia Repair

NCT03225313 | Completed Results

• 1 other identifier: 722014
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized double blinded controlled clinical trial will be done with a total number of 75 patients will be divided into 3 groups. To compare between Ultra-sound guided rectus sheath block VS Field block infiltration in providing a good analgesia for patients undergoing midline hernia repair to detect which one is superior.

Conditions

Ultrasound Guided Rectus Sheath Block; Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

• Immediate Postoperative Pain

  Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

  evaluation of postoperative pain in patients immediately after the procedure.

• Postoperative Pain at 2 Hours After Procedure.

  Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

  evaluation of postoperative pain in patients at 2 hours after procedure.

• Postoperative Pain at 6 Hours After Procedure.

  Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

  Evaluation of postoperative pain in patients at 6 hours after procedure.

Secondary Outcomes (6)

• Change in the Level of Serum Cortisol.

  Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.

• Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique.

  1 hour after the start of the surgery using ELISA technique.

• Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.

  1 hour after the start of the surgery

• Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique.

  30 minutes before the start of the surgery

• Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique.

  30 minutes before the start of the surgery

Study Arms (3)

control group

PLACEBO COMPARATOR

normal saline will be injected in the rectus sheath

Drug: Normal Saline Flush, 0.9% Injectable Solution_#5

Rectus block group

ACTIVE COMPARATOR

bupivicaine will be injected in the rectus sheath

Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4

Field block group

EXPERIMENTAL

bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia

Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4

Interventions

Bupivacaine Hydrochloride 0.5% Injection Solution_#4 DRUG

ultra sound guided injection into the rectus sheath

Rectus block group

Normal Saline Flush, 0.9% Injectable Solution_#5 DRUG

injected into rectus sheath using ultrasound \& locally surrounding the hernia

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective midline hernia repair surgery.
• Age: adult patients between 18 - 60 years old.
• Gender: Both male and female.
• ASA Class: I \& II.

You may not qualify if:

• Refusal of patient.
• Pregnancy and lactation.
• Fever or sepsis.
• Patients ASA III or IV.
• Addicts and drug abusers.
• Patients taking corticosteroids or any cardio - active drugs.
• Local infection at site of the injection.
• Allergy to any of the study medications.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr Muhammed Hussein
• Organization: Theodor Bilharz Research Institute

muhamed.hussein@gmail.com

00201001434459

Study Officials

• mohammed ma hussein, lecturer

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Surgical intensive care

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: July 21, 2017
• Study Start: August 10, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: March 9, 2021
• Results First Posted: July 11, 2019

Record last verified: 2021-03

Locations

EG (1)