Efficacy of Preventive Ketamine on Postoperative Pain

Phase 4

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: bupivacaine(intraperitoneally); Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally); Drug: bupivacaine(intraperitoneally) and ketamine (intravenously)

• Registration Number: NCT04908579
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-01
• Study Start: 2021-06-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-23
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• • Body mass index > 35 and < 60 kg/m2
• Either medically free or with well controlled hypertension and/or diabetes.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
- GROUP (III) (Control): 30 patients	bupivacaine(intraperitoneally)	-
- GROUP (I): 30 patients	bupivacaine(intraperitoneally) and ketamine (intraperitoneally)	-
- GROUP (II): 30 patients	bupivacaine(intraperitoneally) and ketamine (intravenously)	-

Primary Outcome Measures

Name	Time	Method
Time to first given rescue analgesia(minutes)	24 hours postoperatively	Time to first given rescue analgesia(minutes)

Trial Locations

Locations (1)

Ain-Shams University Hospitals; 🇪🇬 Cairo, Egypt