- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01679106
The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Fentanyl IV PCA and placebo TAP catheter
Patients will receive 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.
|
Patients will receive TAP catheter with continuous infusion of Ropivicaine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
day 1
|
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).
|
Day 1
|
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).
|
Day 2
|
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).
|
Day 3
|
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).
|
30 days
|
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).
|
Day 2
|
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).
|
Day 3
|
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).
|
Day 30
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-559
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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