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Completed

NCT Number: NCT04545801

Ketamine for Analgesia After Cesarean Section

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.

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Key information

Conditions

Cesarean Section Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.25 mg/kg of Ketamine

Drug

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

20ml of normal saline solution

Drug

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

Primary outcomes

  1. Dynamic Visual Analog Scale

    Time frame: 24 hours after cesarean section

    Pain score VAS range from 0 to 10, high scores mean worse outcome

Sponsors and collaborators

Lead sponsor

Mongi Slim Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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