Study Stopped
slow enrollment, and unusable data
ssTAP vs TAP Catheters in TAH
Comparing the Efficacy of Transversus Abdominis Plane Block, Both Single Injection and Continuous Block Technique, to Wound Infiltration for Total Abdominal Hysterectomy: A Prospective Randomized Study
1 other identifier
interventional
15
1 country
1
Brief Summary
Prospective, randomized study comparing local wound infiltration with local anesthetic (LA) versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths) catheters with LA for treatment of postoperative pain after total abdominal hysterectomy (TAH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 postoperative-pain
Started Sep 2016
Typical duration for phase_3 postoperative-pain
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
August 14, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedStudy Start
First participant enrolled
September 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2018
CompletedJuly 9, 2018
July 1, 2018
1.7 years
August 14, 2015
July 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Total morphine consumption postoperatively for pain management as measured by the Visual Analog Scale (VAS) pain scale.
The total morphine consumption used post operatively to manage pain will be measured utilizing the VAS pain scale with 0 being no pain and 10 being as much pain as can be tolerated.
Up to 48 hours post treatment
Study Arms (3)
Wound Infiltration
PLACEBO COMPARATOR0.5mg/kg of 0.25% bupivacaine will be injected around the incision for wound infiltration
TAP Blocks
EXPERIMENTAL20mL of 0.25% bupivacaine will be injected on each side of the abdomen for ssTAP procedures
TAP Catheters
EXPERIMENTAL20mL of 0.25% bupivacaine will be injection on each side of the abdomen and catheters placed for repeat bolus every 12 hours with 20mL of 0.25% Bupivacine until 48 hours post procedure or hospital discharge.
Interventions
Eligibility Criteria
You may qualify if:
- Scheduled to undergo total abdominal hysterectomy
- Age ≥ 18 years.
- American Society of Anesthesiologists (ASA) physical status ≤ 3
You may not qualify if:
- Known coagulopathy
- Known allergy to Bupivacaine or morphine
- Contraindication to Tylenol usage
- Medical conditions contraindicated to bupivacaine use
- Daily narcotic usage for ≥ 2 weeks of 20mg of oxycodone daily or an equivalent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Tingle, M.D.
University of Arkansas
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2015
First Posted
August 18, 2015
Study Start
September 12, 2016
Primary Completion
June 5, 2018
Study Completion
June 5, 2018
Last Updated
July 9, 2018
Record last verified: 2018-07