Efficacy of Preventive Ketamine on Postoperative Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bupivacaine(intraperitoneally) and ketamine (intraperitoneally), bupivacaine(intraperitoneally) and ketamine (intravenously), bupivacaine(intraperitoneally).
- Who it may be relevant to
- Registry conditions: Postoperative Pain. Basic parameters: 21 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy
Overview
* 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
- Drug bupivacaine(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. - Drug bupivacaine(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. - Drug bupivacaine(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.
Primary outcome measures
- Time to first given rescue analgesia(minutes) [Time frame: 24 hours postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Ain-Shams University Hospitals — Cairo
Identifiers
NCT: NCT04908579 · FMASU MD 87/ 2021