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

NCT ID: NCT03225313

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-10
• Study Completion Date: 2017-12-30

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.

Detailed Description

75 patients undergoing midline hernia repair under general anesthesia will be recruited and will be randomly allocated using closed envelope technique as follows: Control group, Local infilteration (Field block infilteration) group, Ultra sound Guided Rectus sheath block group.

General anesthesia will be standardized for all patients with :

2 µg kg-1 fentanyl and 2 mg kg-1 propofol. Neuromuscular blockade will be achieved with 0.5 mg kg-1 atracurium followed by tracheal intubation.

Muscle relaxation will be maintained by 0.1mg / kg / 30 minute of Atracrurium. Anesthesia will be maintained by sevoflurane. Mechanical ventilation will be adjusted with fresh gas flow oxygen in air 30-50% at a rate of 1 L min-1to maintain end-tidal carbon dioxide of 35-40 mm Hg and Spo2 greater than 94%.

BIS values will be maintained between 40 and 60. All surgical procedures will be done in the range between 10 am and 1 pm and by the same surgical team.

1. Control group : will receive field block using 0.3 ml/kg of normal saline at site of the hernia plus ultra- sound guided rectus sheath injection using 0.3 ml / kg of normal saline.

2. Field block group: will receive 0.3 ml / kg of 0.5% bupivicaine subcutaneously surrounding the site of the hernia following the induction of anesthesia and ultra-sound guided rectus sheath block with 0.3 ml / kg of normal saline.

3. Ultrasound guided rectus sheath block : Under sterile conditions a 21/22 G , 50- 100 milli meter length echogenic needle guided by the ultrasound into rectus sheath at the level of the umbilicus , using an - in plane technique. After -ve aspiration 0.3 ml/ kg of 0.5 % bupivicaine will be deposited on each side and the spread of local anesthesia will be observed by ultrasound plus 0.3 ml/kg of normal saline subcutaneously at the site of the hernia.

All solutions used will be prepared by a colleague who will not participate into the study.

Conditions

Ultrasound Guided Rectus Sheath Block; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

control group

normal saline will be injected in the rectus sheath

Group Type: PLACEBO_COMPARATOR

Normal Saline Flush, 0.9% Injectable Solution_#5

Intervention Type: DRUG

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

Rectus block group

bupivicaine will be injected in the rectus sheath

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride 0.5% Injection Solution_#4

Intervention Type: DRUG

ultra sound guided injection into the rectus sheath

Field block group

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

Group Type: EXPERIMENTAL

Bupivacaine Hydrochloride 0.5% Injection Solution_#4

Intervention Type: DRUG

locally surrounding the hernia

Interventions

Bupivacaine Hydrochloride 0.5% Injection Solution_#4

ultra sound guided injection into the rectus sheath

Intervention Type: DRUG

Normal Saline Flush, 0.9% Injectable Solution_#5

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

Intervention Type: DRUG

Bupivacaine Hydrochloride 0.5% Injection Solution_#4

locally surrounding the hernia

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Elective midline hernia repair surgery.

2. Age: adult patients between 18 - 60 years old.

3. Gender: Both male and female.

4. ASA Class: I & II.

Exclusion Criteria

1. Refusal of patient.

2. Pregnancy and lactation.

3. Fever or sepsis.

4. Patients ASA III or IV.

5. Addicts and drug abusers.

6. Patients taking corticosteroids or any cardio - active drugs.

7. Local infection at site of the injection.

8. Allergy to any of the study medications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Theodor Bilharz Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Hussein

Lecturer of Anesthesia and Surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mohammed ma hussein, lecturer

Role: PRINCIPAL_INVESTIGATOR

Theodor Bilharz Research Institute

Locations

Theodor Bilharz Research Institute

Giza, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

722014

Identifier Type: -

Identifier Source: org_study_id