Comparison of Three Techniques for Analgesia After Abdominoplasty
Maha1
The Efficacy of Three Different Surgically Infiltrated Local Anesthetic Techniques in Abdominoplasty
1 other identifier
interventional
48
1 country
1
Brief Summary
This study was conducted to demonstrate post-abdominoplasty analgesic duration consequent to three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were also recorded.
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 Mar 2017
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
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 3, 2017
CompletedFirst Posted
Study publicly available on registry
March 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2017
CompletedMarch 13, 2017
March 1, 2017
3 months
March 3, 2017
March 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
morphine consumption (mg)
postoperative morphine consumption in milligrams in the 1st 24 hours postoperatively
up to 24 hours
Study Arms (3)
Transevrsus abdominus plane block group
ACTIVE COMPARATORRectus sheath block group
ACTIVE COMPARATORlocal infiltration group
ACTIVE COMPARATORInterventions
a blunt needle was advanced in the midaxillary line to reach the fascial layer between the internal oblique and transverse abdominis muscles detected by facial click sensation. The LA was slowly injected so as to detect any sign of toxicity or incorrect needle tip position (as resistance) requiring needle repositioning then TAPB was repeated on the opposite side.
In RSB group, 2-3 cm from midline, about 3-5 cm above the umbilicus, the needle was advanced at right angle to the skin. The needle reaches the space between the posterior layer of the rectus sheath and rectus abdominis muscle detected by firm resistance of the posterior wall, The LA was slowly injected then the same steps were repeated on the other side.
40 mls of 0.255 bupivacaine will be infiltrated at skin incision
Eligibility Criteria
You may qualify if:
- all patients listed for abdominoplasty
You may not qualify if:
- allergy to bupivacaine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university
Al Mansurah, Dakahlia Governorate, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
March 3, 2017
First Posted
March 13, 2017
Study Start
March 1, 2017
Primary Completion
June 5, 2017
Study Completion
June 15, 2017
Last Updated
March 13, 2017
Record last verified: 2017-03