Ketamine for Analgesia After Cesarean Section

NCT ID: NCT04545801

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Cesarean Section Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ketamine Group

Patients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia

Group Type ACTIVE_COMPARATOR

0.25 mg/kg of Ketamine

Intervention Type DRUG

patients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia

Placebo Group

Group Type PLACEBO_COMPARATOR

20ml of normal saline solution

Intervention Type DRUG

20ml of normal saline solution intravenously 5 minutes after spinal anesthesia

Interventions

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0.25 mg/kg of Ketamine

patients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia

Intervention Type DRUG

20ml of normal saline solution

20ml of normal saline solution intravenously 5 minutes after spinal anesthesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mongi Slim Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mhamed Sami Mebazaa

Professor, head of department of anesthesia and critical care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mongi Slim University Hospital

La Marsa, Tunis Governorate, Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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ketamine cesarean

Identifier Type: -

Identifier Source: org_study_id

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