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

This study has been terminated.
(Study closed because of low enrolment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679106
First Posted: September 5, 2012
Last Update Posted: May 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
  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 (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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).


Enrollment: 3
Study Start Date: August 2012
Study Completion Date: May 2014
Primary Completion Date: May 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01679106     History of Changes
Other Study ID Numbers: 12-559
First Submitted: August 31, 2012
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