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

Study Overview
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Brief Summary
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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
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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. 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. 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. 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.

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

Conditions
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Ultrasound Guided Rectus Sheath Block, Pain, Postoperative

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4
* Drug: Normal Saline Flush, 0.9% Injectable Solution_#5
* Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective midline hernia repair surgery. Age: adult patients between 18 - 60 years old. Gender: Both male and female. ASA Class: I & II. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. |