An interventional study of TAP catheter with Ropivicaine and Fentanyl IV PCA and placebo TAP catheter in Pain, sponsored by The Cleveland Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-23.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Supportive care
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 3 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will receive Fentanyl IV PCA and placebo TAP catheter.
Other: Fentanyl IV PCA and placebo TAP catheter
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.
Patients will receive placebo TAP catheter with Fentanyl IV PCA.
Effect of continuous TAP analgesia and pain scores
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).
Time frame: day 1
Effect of TAP analgesia and opioid requirements
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).
Time frame: Day 1
Effect of continuous TAP analgesia on pain scores
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).
Time frame: Day 2
effect of continuous TAP analgesia on pain scores
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).
Time frame: Day 3
Effect of continuous TAP analgesia on pain scores
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).
Time frame: 30 days
Effect of TAP analgesia on opioid requirements
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).
Time frame: Day 2
Effect of TAP analgesia on opioid requirements
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).
Time frame: Day 3
Effect of TAP analgesia on opioid requirements
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).
Time frame: Day 30
The record gives a start of Aug 2012, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.