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

• ClinicalTrials.gov Identifier: NCT01679106
• Recruitment Status: Terminated
• First Posted: September 5, 2012
• Last Update Posted: May 23, 2016
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Other: TAP catheter with Ropivicaine; Other: Fentanyl IV PCA and placebo TAP catheter	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Study Start Date: August 2012
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Effect of continuous TAP analgesia and pain scores [ Time Frame: 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).
2. Effect of TAP analgesia and opioid requirements [ Time Frame: 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).
3. Effect of continuous TAP analgesia on pain scores [ Time Frame: Day 2 ]
   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).
4. effect of continuous TAP analgesia on pain scores [ Time Frame: 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).
5. Effect of continuous TAP analgesia on pain scores [ Time Frame: 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).
6. Effect of TAP analgesia on opioid requirements [ Time Frame: Day 2 ]
   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).
7. Effect of TAP analgesia on opioid requirements [ Time Frame: 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).
8. Effect of TAP analgesia on opioid requirements [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01679106
• Other Study ID Numbers: 12-559
• First Posted: September 5, 2012
• Last Update Posted: May 23, 2016
• Last Verified: May 2016

Keywords provided by The Cleveland Clinic:

renal transplant; flank incision

Additional relevant MeSH terms:

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