Clinical trial NCT03225313: Comparison Between Ultra Sound Guided Rectus Sheath Block and Field Block for Midline Hernia Repair
Official title: Ultra Sound Guided Rectus Sheath Block or Field Block for Midline Hernia Repair: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Guided Rectus Sheath Block
Pain, Postoperative
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Immediate Postoperative Pain
timeFrame: evaluation of postoperative pain in patients immediately after the procedure.
measure: Postoperative Pain at 2 Hours After Procedure.
timeFrame: evaluation of postoperative pain in patients at 2 hours after procedure.
measure: Postoperative Pain at 6 Hours After Procedure.
timeFrame: Evaluation of postoperative pain in patients at 6 hours after procedure.
Secondary outcomes:
measure: Change in the Level of Serum Cortisol.
timeFrame: Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.
measure: Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique.
timeFrame: 1 hour after the start of the surgery using ELISA technique.
measure: Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.
timeFrame: 1 hour after the start of the surgery
measure: Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique.
timeFrame: 30 minutes before the start of the surgery
measure: Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique.
timeFrame: 30 minutes before the start of the surgery
measure: Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.
timeFrame: 30 minutes before the start of the surgery.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
affiliation: Theodor Bilharz Research Institute
name: mohammed ma hussein, lecturer
role: PRINCIPAL_INVESTIGATOR
References: