Pain
Conditions
Keywords
renal transplant, flank incision
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.
Interventions
OTHERTAP catheter with Ropivicaine
Patients will receive TAP catheter with continuous infusion of Ropivicaine.
OTHERFentanyl IV PCA and placebo TAP catheter
Patients will receive placebo TAP catheter with Fentanyl IV PCA.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of continuous TAP analgesia and pain scores | 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 | 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 | 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 | 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 | 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). |
Countries
United States
Outcome results
None listed