Clinical trial

Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy

Name

FMASU MD 87/ 2021

Description

* 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.

Trial arms

Trial start

2021-06-15

Estimated PCD

2024-09-30

Trial end

2024-09-30

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

- GROUP (I): 30 patients

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.

Arms:

- GROUP (II): 30 patients

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.

Arms:

- GROUP (III) (Control): 30 patients

Size

Primary endpoint

Time to first given rescue analgesia(minutes)

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2024-06-04

1 organization

2 products

1 indication

Organization

Ain Shams University

Product

Bupivacaine + Ketamine

Indication

Postoperative Pain

Product

bupivacaine(intraperitoneally)