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

NCT01679106 | Terminated

• 1 other identifier: 12-559
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

renal transplant; flank incision

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Fentanyl IV PCA and placebo TAP catheter

PLACEBO COMPARATOR

Patients will receive Fentanyl IV PCA and placebo TAP catheter.

Other: Fentanyl IV PCA and placebo TAP catheter

TAP catheter with continuous infusion of Ropivicaine

ACTIVE COMPARATOR

Patients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery.

Other: TAP catheter with Ropivicaine

Interventions

TAP catheter with Ropivicaine OTHER

Patients will receive TAP catheter with continuous infusion of Ropivicaine.

TAP catheter with continuous infusion of Ropivicaine

Fentanyl IV PCA and placebo TAP catheter OTHER

Patients will receive placebo TAP catheter with Fentanyl IV PCA.

Fentanyl IV PCA and placebo TAP catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ehab Farag, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 23, 2016

Record last verified: 2016-05

Locations

US (1)