Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block in Caesarean Section
1 other identifier
interventional
60
1 country
1
Brief Summary
Transversus Abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries. this study is conducted to analyse the effect of addition of dexmedetomidine to bupivacaine in Transversus Abdominis Plane (TAP) block.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2024
CompletedFirst Submitted
Initial submission to the registry
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedMarch 5, 2024
March 1, 2024
4 months
February 21, 2024
March 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Post operative pain
visual analog score from 0 to 10 where 0 is no pain and 10 worst pain ever
24 hours
Secondary Outcomes (4)
Sedation
24 hours
Heart rate
24 hours
Total analgesic consumption
24 hours
Side effects
24hours
Study Arms (2)
Group Bupivacain Plus dexamethasone
ACTIVE COMPARATORreceiving plain bupivacaine 0.1%, 35 ml with dexmedetomidine 0.5
Group bupivacain
PLACEBO COMPARATORplain bupivacaine 0.25%, 25 ml bilaterally
Interventions
Bupivacain 0.1%, 35 ml with dexmedetomidine 0.5 µG/kg on each side
plain bupivacaine 0.25%, 25 ml bilaterally
Eligibility Criteria
You may qualify if:
- pregnant female elected for cesarean section
- ASAll
You may not qualify if:
- coagulopathy
- BMI\>35
- heart Diseases
- diabets
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Menoufia University
Cairo, Governorate, 32511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
rabab M habeeb
Menoufia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 21, 2024
First Posted
March 5, 2024
Study Start
October 10, 2023
Primary Completion
February 1, 2024
Study Completion
February 20, 2024
Last Updated
March 5, 2024
Record last verified: 2024-03