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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:
The Cleveland Clinic
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01679106
First received: August 31, 2012
Last updated: May 20, 2016
Last verified: May 2016
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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| 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
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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
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
| 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: | May 20, 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 |
ClinicalTrials.gov processed this record on August 22, 2017