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

Purpose

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.

Condition	Intervention
Pain	Other: TAP catheter with Ropivicaine Other: Fentanyl IV PCA and placebo TAP catheter


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Fentanyl Fentanyl citrate

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

Effect of continuous TAP analgesia and pain scores [ Time Frame: day 1 ] [ Designated as safety issue: No ]
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 and opioid requirements [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
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).


Estimated Enrollment:	174
Study Start Date:	August 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Fentanyl IV PCA and placebo TAP catheter Patients will receive Fentanyl IV PCA and placebo TAP catheter.	Other: Fentanyl IV PCA and placebo TAP catheter Patients will receive placebo TAP catheter with Fentanyl IV PCA.
Active Comparator: TAP catheter with continuous infusion of Ropivicaine Patients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery.	Other: TAP catheter with Ropivicaine Patients will receive TAP catheter with continuous infusion of Ropivicaine.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679106

Locations


United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators


Principal Investigator:	Ehab Farag, M.D.	The Cleveland Clinic

More Information

No publications provided


Responsible Party:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01679106 History of Changes
Other Study ID Numbers:	12-559
Study First Received:	August 31, 2012
Last Updated:	February 21, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:


renal transplant flank incision

Additional relevant MeSH terms:


Fentanyl Adjuvants, Anesthesia Analgesics Analgesics, Opioid Anesthetics Anesthetics, General Anesthetics, Intravenous Central Nervous System Agents	Central Nervous System Depressants Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015