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

NCT03469700 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-09-27

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

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.

Sponsors & Collaborators

  • Makassed General Hospital

    lead OTHER

Principal Investigators

  • Saleh Kanawati, MD · Makassed General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03469700 on ClinicalTrials.gov