Pain Management Following TRAM Flap for Breast Reconstruction

This study has been completed.
Sponsor:
Collaborator:
I-Flow
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00500565
First received: July 10, 2007
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

The objective of this pilot study is to examine the efficacy of the ON~Q Pain Relief System plus Intravenous Patient Controlled Analgesia (IVPCA) with Morphine vs IV PCA alone in patients undergoing free transverse rectus abdominis musculocutaneous (TRAM) flap surgery. The primary outcome measure will be postoperative opioid analgesia requirements. Other outcomes will also be assessed, including pain scores, quality of recovery, and resource utilization.


Condition Intervention
Breast Cancer
Drug: Saline
Drug: Bupivicaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Controlled Trial of Two Methods of Postoperative Pain Management Following Free Transverse Rectus Abdominous Musculocutaneous (TRAM) Flap for Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Total Postoperative Opioid Use by Patient [ Time Frame: Measurements performed and recorded every 6 hours while patient is hospitalized. ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: December 2003
Study Completion Date: June 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: On-Q pump with Saline
On-Q Pump with Saline
Drug: Saline
On-Q Pain Pump filled with Saline. The On-Q pump will be connected to the catheter to deliver a constant flow of saline for up to 5 days.
Experimental: On-Q Pump with Bupivicaine
On-Q Pump with bupivicaine
Drug: Bupivicaine
On-Q Pain Pump filled with 0.375% Bupivicaine through two catheters at a total rate of 4 cc/hr over 111 hours. The On-Q pump will be connected to the catheter to deliver a constant flow of Bupivicaine for up to 5 days.

Detailed Description:

Inadequate control of surgical pain after free TRAM procedures may lead to complications and delay recovery time. This could lead to a longer stay in the hospital. The standard care for pain after a free TRAM procedure has been with drugs that are anesthetics. Unfortunately, these anesthetics are not long lasting and usually require the use of opioids (morphine or hydromorphone) to control "break-through" pain. A continuous delivery of local anesthetic to the wound site may provide better control of pain and decrease the need for the use of opioids. This may decrease the length of the hospital stay as well as other side effects associated with the treatment of pain.

Before the study, you will be asked questions about your health, your age, and about any allergies you may have. Women who are able to have children must have a negative blood pregnancy test. You will have already been scheduled to undergo a free TRAM flap procedure.

During free TRAM flap procedure, you will have two "soaker catheters" placed by the surgeon directly into the surgical site. The catheters are flexible tubes which will allow pain medicine (or saline) to be delivered directly to the donor wound site which is the abdominal site from where the tissue for breast reconstruction is taken. A small pump (On-Q pump) will be connected to the catheter to deliver a constant flow of pain medicine (or saline) for up to 5 days. The On-Q pump is completely portable and can be attached to your hospital gown to allow for movement.

You will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in the first group will have the On-Q pump filled with saline. Participants in the other group will have the On-Q pump filled with bupivicaine.

Participants in both groups will receive IVPCA, which is the standard of care for pain relief. The IVPCA will be placed on PRN mode which means you will be able to press a button to deliver pain medication whenever you feel pain.

You will be asked questions about your pain and your recovery process every 6 hours while you are awake for up to 5 days. You will also be asked to fill out a questionnaire about pain once a day during treatment. It should take around 10 minutes to complete the questionnaire.

The catheters will be removed after 5 days of treatment (or your last day in the hospital, whichever is sooner) by one of the surgeons that participated in the surgery

During the study, if you experience any intolerable side effects or your doctor feels it is in your best interest to stop treatment, you will be taken off the study and other treatment options will be discussed with you.

This is an investigational study. The On-Q device, PCA, and bupivicaine are FDA approved and commercially available. Up to 60 participants will take part in this study (30 in each group). All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center (MDACC).

This protocol is partially funded by a research grant from the I-Flow Corporation.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with or undergoing unilateral elective free TRAM flap for breast reconstruction, immediate or delayed, with or without a surgical revision of the contralateral breast for asymmetry.
  • American Society of Anesthesiology Physical Status I - III patients.
  • Patients has given voluntary written informed consent before performance of any study-related procedure.

Exclusion Criteria:

  • Patients undergoing bilateral TRAM flap reconstruction.
  • Patients with a prior allergic reaction to Marcaine (bupivacaine) or other amide local anesthetics.
  • Patients with a prior allergic reaction to Morphine and Hydromorphone.
  • Patients undergoing any other unrelated surgical procedure to the breast reconstruction.
  • Patient refusal to participate.
  • Patient required major abdominal surgery within four weeks prior to enrollment.
  • Patients being treated for chronic pain or using daily intake of opioid analgesics.
  • Patients with a history of abuse of recreational drugs or alcohol.
  • Patients with any laboratory values or underlying disease, which in the investigator's opinion would preclude them from participation in the trial, specifically: (A) significant liver dysfunction (eg. bilirubin, AST and/or ALT >1.5 times the upper limit of normal value (B) cardiac conduction defects noted by history or on the pre-op screening EKG.
  • Pregnant or breast feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT00500565

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
I-Flow
Investigators
Principal Investigator: Charles E. Butler, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500565     History of Changes
Other Study ID Numbers: ID03-0046
Study First Received: July 10, 2007
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
On-Q Pain Relief System
Transverse Rectus Abdominous Myocutaneous
Breast Reconstruction
TRAM flap
Bupivicaine
Pain Management

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014