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

Not Applicable

Terminated

• Conditions: Pain
• Interventions: Other: Fentanyl IV PCA and placebo TAP catheter; Other: TAP catheter with Ropivicaine

• Registration Number: NCT01679106
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl IV PCA and placebo TAP catheter	Fentanyl IV PCA and placebo TAP catheter	Patients will receive Fentanyl IV PCA and placebo TAP catheter.
TAP catheter with continuous infusion of Ropivicaine	TAP catheter with Ropivicaine	Patients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery.

Primary Outcome Measures

Name	Time	Method
Effect of TAP analgesia and opioid requirements	Day 1	The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Effect of continuous TAP analgesia on pain scores	30 days	The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Effect of TAP analgesia on opioid requirements	Day 30	The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Effect of continuous TAP analgesia and pain scores	day 1	The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
effect of continuous TAP analgesia on pain scores	Day 3	The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States