The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation

NeuroTherapia, Inc.

Status: Terminated

Conditions: Pain

Treatments: Other: Fentanyl IV PCA and placebo TAP catheter; Other: TAP catheter with Ropivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01679106

12-559

Details and patient eligibility

About

Up to 174 patients undergoing renal transplantation will be randomized to one of two groups. Randomization will be based on computer-generated codes using random block sizes ranging from 4 to 8.

Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA

The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic benefit. In addition, the presence of any pain at the incision site will be noted at the 1 month surgical follow-up to determine any evidence of chronic pain.

The investigators hypothesis is that unilateral kidney transplant patients with a continuous TAP catheter will have decreased pain scores and opioid usage compared to those receiving standard analgesic therapy.

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is >18 years of age
• The patient has provided written informed consent and understands the explanation of the protocol.
• The patient is scheduled to have a unilateral renal transplant with a flank incision

Exclusion criteria

• Patients aged <18.
• Patients with a known allergy to amide local anesthetics or para-aminobenzoic acid.
• Patients who are unable to understand the verbal analog pain scale.
• Patients who decline participation.
• Patients with a midline abdominal incision.
• Combined transplants, ie. Kidney-pancreas

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups, including a placebo group

Fentanyl IV PCA and placebo TAP catheter

Placebo Comparator group

Description:

Patients will receive Fentanyl IV PCA and placebo TAP catheter.

Treatment:

Other: Fentanyl IV PCA and placebo TAP catheter

TAP catheter with continuous infusion of Ropivicaine

Active Comparator group

Description:

Patients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery.

Treatment:

Other: TAP catheter with Ropivicaine