Postoperative Pain
Conditions
Brief summary
* Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting. * Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.
Interventions
DRUGbupivacaine(intraperitoneally) and ketamine (intraperitoneally)
1. 40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 2. 10 ml normal saline 0.9% will be given intravenous.
DRUGbupivacaine(intraperitoneally) and ketamine (intravenously)
1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 2. 10 ml volume of ketamine 0.5 mg/kg intravenously will be given after delivering the gastric sleeve and before start closure of port sites.
DRUGbupivacaine(intraperitoneally)
1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 2. 10 ml normal saline 0.9% will be given intravenous.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* \- Body mass index \> 35 and \< 60 kg/m2 * Either medically free or with well controlled hypertension and/or diabetes.
Exclusion criteria
* \- Patient's refusal to participate in the study * BMI \> 60 kg/m2. * Age less than 21 years. * Patients with severe systemic disease which is not life-threatening. * Patients on antipsychotics, antidepressants and/or corticosteroids. * Patients with history of obstructive sleep apnea. * Allergic reaction to any of the study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first given rescue analgesia(minutes) | 24 hours postoperatively | Time to first given rescue analgesia(minutes) |
Countries
Egypt
Contacts
CONTACTIbrahim Mamdouh Esmat
Outcome results
None listed