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

Ultra Sound Guided Rectus Sheath Block or Field Block for Midline Hernia Repair: A Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Ultrasound Guided Rectus Sheath Block
• Intervention / Treatment: Drug: Normal Saline Flush, 0.9% Injectable Solution_#5; Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4; Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Theodor Bilharz Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; normal saline will be injected in the rectus sheath	Drug: Normal Saline Flush, 0.9% Injectable Solution_#5; injected into rectus sheath using ultrasound & locally surrounding the hernia
Active Comparator: Rectus block group; bupivicaine will be injected in the rectus sheath	Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4; ultra sound guided injection into the rectus sheath; Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4; locally surrounding the hernia
Experimental: Field block group; bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia	Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4; ultra sound guided injection into the rectus sheath; Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4; locally surrounding the hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.	1 hour after the start of the surgery using ELISA technique.
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.	Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.	1 hour after the start of the surgery
Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique.	Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery	30 minutes before the start of the surgery
Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique.	Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.	30 minutes before the start of the surgery
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.	Measurement of serum noradrenaline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.	30 minutes before the start of the surgery.

Collaborators and Investigators

• Sponsor: Theodor Bilharz Research Institute
• Investigators: Principal Investigator: mohammed ma hussein, lecturer, Theodor Bilharz Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: June 10, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Bupivacaine
• Other Study ID Numbers: 722014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No