IV and Intrathecal Ketamine in Cesarean Section
Comparison Between the Analgesic Effects of Intrathecal Versus Intravenous Ketamine After Spinal Anaesthesia for Elective Caesarean Delivery :a Randomised Trial
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedMarch 6, 2025
March 1, 2025
1.7 years
December 12, 2022
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time to the first analgesic request
First Postoperative day
Secondary Outcomes (1)
Postoperative pain scores NRS at rest and on movement; (2, 4, 6, 12, and 24 hours) postoperative
first postoperative day
Study Arms (2)
Intrathecal Ketamine
ACTIVE COMPARATORPatients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine.
Intravenous ketamine
ACTIVE COMPARATORPatients will receive IV Ketamine 0.25mg/kg after spinal anesthesia with bupivacaine and morphine.
Interventions
Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine
Patients will receive IV Ketamine 0.25mg/kg after spinal
Eligibility Criteria
You may qualify if:
- Pregnant undergoing elective cesarean section
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university
Asyut, Egypt
Related 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.
PMID: 28520955BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 12, 2022
First Posted
January 11, 2023
Study Start
February 1, 2023
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
March 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share