An interventional study of general anesthesia and Paravertebral block in Pain, Postoperative, sponsored by Makassed General Hospital. Status unknown at 1 site in Lebanon. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by Makassed General Hospital · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
Patients will receive general anesthesia with paravertebral block
Other: general anesthesia · Other: Paravertebral block
Patients will receive general anesthesia with placebo block
Other: general anesthesia · Other: Placebo PVB
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
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 bilateral paravertebral block guided by a nerve stimulator will be performed by injecting normal saline from levels T11 to T6.
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.
Time frame: within 1 week postoperatively
ambulation
The secondary aim is to assess the time of first movement (early ambulation) between both groups. This will be assessed via a questionnaire
Time frame: within 1 week postoperatively
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Makassed General Hospital