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

Makassed General Hospital

Status: Unknown

Conditions: Pain, Postoperative

Treatments: Other: Paravertebral block; Other: general anesthesia; Other: Placebo PVB

Study type: Interventional

Funder types: Other

Identifiers

NCT03469700

15218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

GA+PVB

Experimental group

Description:

Patients will receive general anesthesia with paravertebral block

Treatment:

Other: general anesthesia

Other: Paravertebral block

GA+placebo PVB

Active Comparator group

Description:

Patients will receive general anesthesia with placebo block

Treatment:

Other: Placebo PVB

Other: general anesthesia