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

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

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 5, 2012
Last Update Posted Date May 23, 2016
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
  • 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 opiod 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 opiod 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 opiod 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 opiod 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).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pain
Intervention  ICMJE
  • Other: TAP catheter with Ropivicaine
    Patients will receive TAP catheter with continuous infusion of Ropivicaine.
  • Other: Fentanyl IV PCA and placebo TAP catheter
    Patients will receive placebo TAP catheter with Fentanyl IV PCA.
Study Arms  ICMJE
  • Placebo Comparator: Fentanyl IV PCA and placebo TAP catheter
    Patients will receive Fentanyl IV PCA and placebo TAP catheter.
    Intervention: Other: Fentanyl IV PCA and placebo TAP catheter
  • 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.
    Intervention: Other: TAP catheter with Ropivicaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 20, 2016)
3
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2012)
174
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679106
Other Study ID Numbers  ICMJE 12-559
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ehab Farag, M.D. The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP