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NCT05679375 Clinical Trial

IV and Intrathecal Ketamine in Cesarean Section

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05679375
Other study ID # Ketamine in Cesarean section
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 2023
Est. completion date March 2025

Study information
Verified date December 2022
Source Assiut University
Contact Youstina Tharwat Sedky, Resident doctor
Phone 01275877910
Email Youstinatharwat111@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date March 2025
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Intrathecal ketamine
Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine
• Intravenous ketamine
Patients will receive IV Ketamine 0.25mg/kg after spinal

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Abd El-Rahman AM, Mohamed AA, Mohamed SA, Mostafa MAM. Effect of Intrathecally Administered Ketamine, Morphine, and Their Combination Added to Bupivacaine in Patients Undergoing Major Abdominal Cancer Surgery a Randomized, Double-Blind Study. Pain Med. 2018 Mar 1;19(3):561-568. doi: 10.1093/pm/pnx105. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time to the first analgesic request First Postoperative day
Secondary Postoperative pain scores NRS at rest and on movement; (2, 4, 6, 12, and 24 hours) postoperative first postoperative day
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