The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation

Pain Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01679106
• Other study ID #: 12-559
• Status: Terminated
• Phase: N/A
• First received: August 31, 2012
• Last updated: May 20, 2016
• Start date: August 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• TAP catheter with Ropivicaine
Patients will receive TAP catheter with continuous infusion of Ropivicaine.
• Fentanyl IV PCA and placebo TAP catheter
Patients will receive placebo TAP catheter with Fentanyl IV PCA.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	day 1	No
Primary	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).	Day 1	No
Primary	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).	Day 2	No
Primary	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).	Day 3	No
Primary	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).	30 days	No
Primary	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).	Day 2	No
Primary	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).	Day 3	No
Primary	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).	Day 30	No