NCT03225313

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Theodor Bilharz Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Bupivacaine Hydrochloride 0.5% Injection Solution_#4	ultra sound guided injection into the rectus sheath
DRUG	Normal Saline Flush, 0.9% Injectable Solution_#5	injected into rectus sheath using ultrasound \& locally surrounding the hernia
DRUG	Bupivacaine Hydrochloride 0.5% Injection Solution_#4	locally surrounding the hernia

Timeline

• Start date: 2017-08-10
• Primary completion: 2017-12-30
• Completion: 2017-12-30
• First posted: 2017-07-21
• Last updated: 2021-03-09
• Results posted: 2019-07-11

Locations

1 site across 1 country: Egypt