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ssTAP vs TAP Catheters in TAH

Sponsor
University of Arkansas (Other)
Overall Status
Terminated
CT.gov ID
NCT02525900
Collaborator
(none)
15
Enrollment
1
Location
3
Arms
20.7
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Wound Infiltration
  • Procedure: TAP Blocks
  • Procedure: TAP Catheters
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 12, 2016
Actual Primary Completion Date :
Jun 5, 2018
Actual Study Completion Date :
Jun 5, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Wound Infiltration

0.5mg/kg of 0.25% bupivacaine will be injected around the incision for wound infiltration

Procedure: Wound Infiltration
Wound Infiltration with 0.25% Bupivacine
Experimental: TAP Blocks

20mL of 0.25% bupivacaine will be injected on each side of the abdomen for ssTAP procedures

Procedure: TAP Blocks
bilateral TAP block with 0.25% Bupivacaine
Experimental: TAP Catheters

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.

Procedure: TAP Catheters
bilateral TAP Catheter with repeat bolus of 0.25% Bupivacaine

Outcome Measures

Primary Outcome Measures

  1. Total morphine consumption postoperatively for pain management as measured by the Visual Analog Scale (VAS) pain scale. [Up to 48 hours post treatment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205

Sponsors and Collaborators

  • University of Arkansas

Investigators

  • Principal Investigator: Sarah Tingle, M.D., University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT02525900
Other Study ID Numbers:
  • 204411
First Posted:
Aug 18, 2015
Last Update Posted:
Jul 9, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Jul 9, 2018