ssTAP vs TAP Catheters in TAH

University of Arkansas

Status and phase: Terminated; Phase 3

Conditions: Postoperative Pain

Treatments: Procedure: Wound Infiltration; Procedure: TAP Blocks; Procedure: TAP Catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT02525900

204411

Details and patient eligibility

About

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).

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

15 participants in 3 patient groups, including a placebo group

Wound Infiltration

Placebo Comparator group

Description:

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

Treatment:

Procedure: Wound Infiltration

TAP Blocks

Experimental group

Description:

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

Treatment:

Procedure: TAP Blocks

TAP Catheters

Experimental group

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.

Treatment:

Procedure: TAP Catheters