ssTAP vs TAP Catheters in TAH

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02525900
• Other study ID #: 204411
• Status: Terminated
• Phase: Phase 3
• Start date: September 12, 2016
• Est. completion date: June 5, 2018

Study information

• Verified date: July 2018
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 5, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Wound Infiltration
Wound Infiltration with 0.25% Bupivacine
• TAP Blocks
bilateral TAP block with 0.25% Bupivacaine
• TAP Catheters
bilateral TAP Catheter with repeat bolus of 0.25% Bupivacaine

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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