Pain, Postoperative
Conditions
Brief 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.
Interventions
OTHERgeneral 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
OTHERParavertebral 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%
OTHERPlacebo PVB
Placebo bilateral paravertebral block guided by a nerve stimulator will be performed by injecting normal saline from levels T11 to T6.
Sponsors
Makassed General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | within 1 week postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ambulation | within 1 week postoperatively | The secondary aim is to assess the time of first movement (early ambulation) between both groups. This will be assessed via a questionnaire |
Countries
Lebanon
Contacts
Primary ContactSaleh Kanawati, MD
Outcome results
None listed