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

Not Applicable

Completed

Conditions: Pain, Postoperative
Ultrasound Guided Rectus Sheath Block

Interventions: Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4
Drug: Normal Saline Flush, 0.9% Injectable Solution_#5

Registration Number: NCT03225313

Lead Sponsor: Theodor Bilharz Research Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectus block group	Bupivacaine Hydrochloride 0.5% Injection Solution_#4	bupivicaine will be injected in the rectus sheath
control group	Normal Saline Flush, 0.9% Injectable Solution_#5	normal saline will be injected in the rectus sheath
Field block group	Bupivacaine Hydrochloride 0.5% Injection Solution_#4	bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia

Primary Outcome Measures

Name	Time	Method
Postoperative Pain at 2 Hours After Procedure.	evaluation of postoperative pain in patients 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.
Postoperative Pain at 6 Hours After Procedure.	Evaluation of postoperative pain in patients 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.
Immediate Postoperative Pain	evaluation of postoperative pain in patients immediately after the 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.

Secondary Outcome Measures

Name	Time	Method
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.	1 hour after the start of the surgery using ELISA technique.	Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.	30 minutes before the start of the surgery.	Measurement of serum noradrenaline levels (ng/ml) using ELISA technique 30 minutes before 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 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	Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.