ssTAP vs TAP Catheters in TAH

Phase 3

Terminated

• Conditions: Postoperative Pain
• Interventions: Procedure: TAP Catheters; Procedure: Wound Infiltration; Procedure: TAP Blocks

• Registration Number: NCT02525900
• Lead Sponsor: University of Arkansas

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Study Start: 2016-09-12
• Primary Completion: 2018-06-05
• Study Completion: 2018-06-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Catheters	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.
Wound Infiltration	Wound Infiltration	0.5mg/kg of 0.25% bupivacaine will be injected around the incision for wound infiltration
TAP Blocks	TAP Blocks	20mL of 0.25% bupivacaine will be injected on each side of the abdomen for ssTAP procedures

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States