Back to resultsssTAP vs TAP Catheters in TAH
Primary Purpose
Postoperative Pain
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Wound Infiltration
TAP Blocks
TAP Catheters
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Scheduled to undergo total abdominal hysterectomy
- Age ≥ 18 years.
- American Society of Anesthesiologists (ASA) physical status ≤ 3
Exclusion Criteria:
- 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.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Wound Infiltration
TAP Blocks
TAP Catheters
Arm Description
0.5mg/kg of 0.25% bupivacaine will be injected around the incision for wound infiltration
20mL of 0.25% bupivacaine will be injected on each side of the abdomen for ssTAP procedures
20mL 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02525900
Brief Title
ssTAP vs TAP Catheters in TAH
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment, and unusable data
Study Start Date
September 12, 2016 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wound Infiltration
Arm Type
Placebo Comparator
Arm Description
0.5mg/kg of 0.25% bupivacaine will be injected around the incision for wound infiltration
Arm Title
TAP Blocks
Arm Type
Experimental
Arm Description
20mL of 0.25% bupivacaine will be injected on each side of the abdomen for ssTAP procedures
Arm Title
TAP Catheters
Arm Type
Experimental
Arm Description
20mL 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.
Intervention Type
Procedure
Intervention Name(s)
Wound Infiltration
Intervention Description
Wound Infiltration with 0.25% Bupivacine
Intervention Type
Procedure
Intervention Name(s)
TAP Blocks
Intervention Description
bilateral TAP block with 0.25% Bupivacaine
Intervention Type
Procedure
Intervention Name(s)
TAP Catheters
Intervention Description
bilateral TAP Catheter with repeat bolus of 0.25% Bupivacaine
Primary Outcome Measure Information:
Title
Total morphine consumption postoperatively for pain management as measured by the Visual Analog Scale (VAS) pain scale.
Description
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.
Time Frame
Up to 48 hours post treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled to undergo total abdominal hysterectomy
Age ≥ 18 years.
American Society of Anesthesiologists (ASA) physical status ≤ 3
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Tingle, M.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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ssTAP vs TAP Catheters in TAH
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