IV and Intrathecal Ketamine in Cesarean Section

March 4, 2025 updated by: Youstina Tharwat Sedky, Assiut University

Comparison Between the Analgesic Effects of Intrathecal Versus Intravenous Ketamine After Spinal Anaesthesia for Elective Caesarean Delivery :a Randomised Trial

In the current study, the investigators will compare the effects of low-dose intravenous (i.v.) ketamine versus intrathecal Ketamine added to spinal anesthesia on the time to first request for analgesia and maternal pain scores and overall satisfaction in patients undergoing cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

• Pregnant undergoing elective cesarean section

Exclusion Criteria

  • Significant coexisting diseases (pregnancy-induced hypertension or diabetes)
  • body mass index ≥40kg/m2, height <150cm
  • Current use of pain medication including opioids
  • history of substance abuse or hallucinations, cardiovascular disease, diabetes, multiple gestations
  • chronic pain was excluded.
  • contraindications to spinal anaesthesia,
  • severely compromised fetus requiring general anesthesia and those patients who received labor analgesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intrathecal Ketamine
Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine.
Drug: Intrathecal ketamine
Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine
Active Comparator: Intravenous ketamine
Patients will receive IV Ketamine 0.25mg/kg after spinal anesthesia with bupivacaine and morphine.
Drug: Intravenous ketamine
Patients will receive IV Ketamine 0.25mg/kg after spinal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to the first analgesic request
Time Frame: First Postoperative day
First Postoperative day

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain scores NRS at rest and on movement; (2, 4, 6, 12, and 24 hours) postoperative
Time Frame: first postoperative day
first postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

December 24, 2022

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ketamine in Cesarean section

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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