Ketamine for Analgesia After Cesarean Section

Not Applicable

Completed

• Conditions: Cesarean Section; Postoperative Pain
• Interventions: Drug: 0.25 mg/kg of Ketamine; Drug: 20ml of normal saline solution

• Registration Number: NCT04545801
• Lead Sponsor: Mongi Slim Hospital

Brief Summary

In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

Detailed Description

In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

The patients were randomized in two groups:

* Group Ketamine: these patients recieved 0.25 mg/kg of Ketamin intravenously 5 minutes after the spinal anesthesia.

* Group Placebo: recieved 20 ml of normal saline solution intravenously 5 minutes after the spinal puncture.

The investigators recorded intra demographic, intraoperative and post operative data.

The main outcome was the analgesic score: the visual analog scale (VAS). dynamic VAS was also monitored at 24 hours post operatively.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-03-31
• Study Completion: 2019-04-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-11
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• full term pregnant adult patients
• Monofetal pregnancy
• scheduled for urgent or elective cesarean section under spinal anesthesia

Exclusion Criteria

• necessity of general anesthesia during the procedure
• Post partum hemorrage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Group	0.25 mg/kg of Ketamine	Patients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia
Placebo Group	20ml of normal saline solution	-

Primary Outcome Measures

Name	Time	Method
Dynamic Visual Analog Scale	24 hours after cesarean section	Pain score VAS range from 0 to 10, high scores mean worse outcome

Trial Locations

Locations (1)

Mongi Slim University Hospital; 🇹🇳 La Marsa, Tunis, Tunisia