Dexmedetomine vs Dexamethasone in TAB Block for Abdominal Surgries
A Comparative Study Between the Use of Dexmedetomidine Versus Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Post-operative Pain Relief in Patients Undergoing Lower Open Abdominal Surgeries
1 other identifier
interventional
45
1 country
1
Brief Summary
Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries.
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 Apr 2022
Shorter than P25 for phase_4
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
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2022
CompletedApril 12, 2022
April 1, 2022
3 months
April 5, 2022
April 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
1st time for rescue analgesia
Time to first analgesia requirment(starting from drug injection)
first 24 hours post-operatively
Secondary Outcomes (1)
Pain score- Visual Analogue Score (VAS)
First 24 hours post-operatively.
Study Arms (3)
Group A (n=15): (Dexamethasone group)
ACTIVE COMPARATORPatients will receive 20 ml 0.25% bupivacaine plus 4 mg dexamethasone on each side TAB bock.
Group B (n=15): (Dexmedetomidine group)
ACTIVE COMPARATORPatients will receive 20 ml 0.25% bupivacaine plus 0.5 mcg/kg of dexmedetomidine on each side TAB block.
Group C (n=15): (control group)
SHAM COMPARATORPatients will receive 20 ml 0.25% bupivacaine on each side TAB block.
Interventions
adjuvants to 0.25 bupivacaine in TAB block.
Eligibility Criteria
You may qualify if:
- Adult patients, Age 20-60 years. Elective operation under general anesthesia. Physical Status: ASA I and II Patients. Body mass index 25-35 kg/m2.
You may not qualify if:
- Infection at site of injection.
- Patient refusal.
- Psychiatric or physical illness that lead to inability to cooperate, speak or read.
- Abdominal operations under spinal anesthesia.
- History or evidence of coagulopathy.
- Known allergies to drugs used .
- Preexisting neurological disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University, Faculty of medicine
Cairo, 11591, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yasser Sayed, Master
Ain Shams University, Faculty of medecine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesia specialist
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 12, 2022
Study Start
April 1, 2022
Primary Completion
July 1, 2022
Study Completion
July 5, 2022
Last Updated
April 12, 2022
Record last verified: 2022-04