NCT03469700

General Anesthesia vs Paravertebral Block With General Anesthesia For Laparoscopic Sleeve Gastrectomy

General Anesthesia vs Paravertebral Block With General Anesthesia For Post-Operative Pain Post Laparoscopic Sleeve Gastrectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Makassed General Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The incidence of obesity is steadily rising. Laparoscopic sleeve gastrectomy (LSG) is an innovative approach to the surgical management of morbid obesity. We will be discussing the effect of adding paravertebral block (PVB) in addition to general anesthesia (GA) vs. GA alone for post operative pain after laparoscopic sleeve gastrectomy.

Detailed description

This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups: Group 1 will be patients who receive general anesthesia with paravertebral block, whereas group 2 will be patients who receive general anesthesia with placebo block.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
OTHER	general anesthesia	Induction of general anesthesia will be performed followed by endotracheal intubation. General anesthesia is induced with 0.5-1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.6 mg/kg/h rocuronium, 60% nitrous oxide and 40% oxygen with Ultiva (Remifentanyl) 0.1-0.2 μg/kg/hr
OTHER	Paravertebral block	Bilateral paravertebral block guided by a nerve stimulator will be performed by injecting local anesthetic mixture from levels T11 to T6. Each 20 ml of the mixture will contain: 6 ml lidocaine 2%; 6 ml lidocaine 2% with adrenaline 5 μg /ml; 5 ml bupivacaine 0.5%; 50μg fentanyl (1 ml); and 2 ml saline 0.9%
OTHER	Placebo PVB	Placebo bilateral paravertebral block guided by a nerve stimulator will be performed by injecting normal saline from levels T11 to T6.

Timeline

• Start date: 2018-03-15
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-03-19
• Last updated: 2019-09-27

Locations

1 site across 1 country: Lebanon