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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01679106
First received: August 31, 2012
Last updated: February 21, 2014
Last verified: February 2014
  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:


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

ClinicalTrials.gov processed this record on August 01, 2014