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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03469700
• Other study ID #: 15218
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Makassed General Hospital
• Contact: Saleh Kanawati, MD
• Phone: +9611636000
• Email: s.kanawati[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients with body mass index (BMI) greater than or equal to 30

• American Society of Anesthesiologist (ASA) score greater than or equal to 2

• Undergoing laparoscopic gastric sleeve surgeries

Exclusion Criteria:

• Patients with ASA score less than 2 and greater than 4

• Patients with any type of allergy to local anesthesia

• Patients refusing to be part of the study (refusal to sign consent)

• Any complication during surgery or anesthesia

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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
• 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%
• Placebo PVB
Placebo bilateral paravertebral block guided by a nerve stimulator will be performed by injecting normal saline from levels T11 to T6.

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	The primary aim is to compare the effect of paravertebral block with general anesthesia versus general anesthesia alone on postoperative pain after laparoscopic sleeve gastrectomy surgeries. Pain will be assessed using the Visual Analogue scale (VAS) with a score of 0 denoting no pain and 10 maximum possible pain.	within 1 week postoperatively
Secondary	ambulation	The secondary aim is to assess the time of first movement (early ambulation) between both groups. This will be assessed via a questionnaire	within 1 week postoperatively