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
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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 |
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Pain | Other: TAP catheter with Ropivicaine Other: Fentanyl IV PCA and placebo TAP catheter | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Fentanyl IV PCA and placebo TAP catheter
Patients will receive Fentanyl IV PCA and placebo TAP catheter.
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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.
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Other: TAP catheter with Ropivicaine
Patients will receive TAP catheter with continuous infusion of Ropivicaine. |
- 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).

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Ehab Farag, M.D. | The Cleveland Clinic |
Responsible Party: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT01679106 |
Other Study ID Numbers: |
12-559 |
First Posted: | September 5, 2012 Key Record Dates |
Last Update Posted: | May 23, 2016 |
Last Verified: | May 2016 |
renal transplant flank incision |
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 |