Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Gedge Rosson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01494259
First received: December 13, 2011
Last updated: December 15, 2011
Last verified: December 2011
  Purpose

This double-blind, randomized, controlled clinical trial comparing patient-reported pain and pain medication/narcotic use between patients randomized to treatment (bupivacaine) or placebo (saline) delivered via pain pump to the mastectomy site. Candidates will have chosen to have a mastectomy on one side immediately followed with tissue expander placement breast reconstruction.

Patients will be randomized 1:1 to bupivacaine- (treatment) or saline-(placebo) filled percutaneously-placed pain pumps; neither the participants nor the study staff will know participants' treatment. Data on patient-perceived pain and pain medication use will be collected before surgery, during surgery, and after surgery on Days 1, 2, 3, 7, and 90, and at Years 2 and 4 by phone.

The investigators hypothesize that patients randomized to the treatment (bupivacaine) group will have significantly lower pain scores and use less pain medicine than patients who receive placebo during the first 90 days following their surgery. The Year 2 and Year 4 follow-ups are included as tertiary endpoints to capture differences in chronic pain, and patients will be asked to complete the same questionnaires as at the Day 90 follow up.


Condition Intervention Phase
Pain
Drug: Bupivacaine
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Use of Percutaneously-Placed Continuous Flow Bupivacaine Pain Pumps to Decrease Post-operative Pain Following Mastectomy With Immediate Reconstruction: A Prospective, Randomized, Double-Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Differences in post-operative static and moving pain scores between patients randomized either to bupivacaine- (treatment) or saline- (placebo) filled, percutaneously-placed pain pump analgesic administration for post-operative pain control. [ Time Frame: Day of Surgery through Day 7 ] [ Designated as safety issue: No ]
    Post-operative pain, pain medication/narcotic use, and assessment for adverse events (AEs)/serious adverse events (SAEs) will be assessed the Day of surgery through post-operative Day 7. A clinic visit occurs on Day 7 when the pain pump will be removed and additional data collected (updated medical history, pain medication/narcotic use, AEs/SAEs, and study questionnaires).


Secondary Outcome Measures:
  • Document long-term changes in QOL scores between patients randomized either to bupivacaine- (treatment) or saline- (placebo) filled, percutaneously-placed pain pump analgesic administration for post-operative pain control. [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Document long-term changes in Quality of Life (QOL) scores [the RAND-36 Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and Breast-Q scores] between women undergoing unilateral mastectomy followed by unilateral immediate tissue expander breast reconstruction randomized either to bupivacaine- (treatment) or saline- (placebo) filled, percutaneously-placed pain pump analgesic administration for post-operative pain control.

  • Document long-term changes in QOL scores between patients randomized either to bupivacaine- (treatment) or saline- (placebo) filled, percutaneously-placed pain pump analgesic administration for post-operative pain control. [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
    Document long-term changes in Quality of Life (QOL) scores [the RAND-36 Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and Breast-Q scores] between women undergoing unilateral mastectomy followed by unilateral immediate tissue expander breast reconstruction randomized either to bupivacaine- (treatment) or saline- (placebo) filled, percutaneously-placed pain pump analgesic administration for post-operative pain control.

  • Document long-term changes in QOL scores between patients randomized either to bupivacaine- (treatment) or saline- (placebo) filled, percutaneously-placed pain pump analgesic administration for post-operative pain control. [ Time Frame: Year 4 ] [ Designated as safety issue: No ]
    Document long-term changes in Quality of Life (QOL) scores [the RAND-36 Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and Breast-Q scores] between women undergoing unilateral mastectomy followed by unilateral immediate tissue expander breast reconstruction randomized either to bupivacaine- (treatment) or saline- (placebo) filled, percutaneously-placed pain pump analgesic administration for post-operative pain control.


Estimated Enrollment: 70
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivacaine (Treatment) Group
The Symbios GOPump is the Food and Drug Administration-approved delivery device used to infuse the bupivacaine. The pump is attached to catheters placed in the patient's breast reconstruction site. A 10cm long 16-guage needle is provided to aid insertion of the catheter into the patient. The entire catheter will pass through the bore of the introducer needle. A 60cc syringe is used to fill the Symbios GOPump through the fill port. After filling the 60cc syringe with up to 300cc of 0.5% bupivacaine, the syringe is attached to the port and the medication injected into the infusion pump. The steady-flow pressure regulator maintains a constant 6 psi pressure in the outflow chamber ensuring a uniform flow of medication through each catheter inserted into the Symbios GOPump.
Drug: Bupivacaine
Up to 300cc of 0.5% bupivacaine administered to the mastectomy site via 2 catheters connected to the Symbios GOPump at a rate of 2 cc per hour per catheter over 3 days.
Other Name: Marcaine with epinephrine
Placebo Comparator: Saline (Placebo) Group
The Symbios GOPump is the Food and Drug Administration-approved delivery device used to infuse the saline. The pump is attached to catheters placed in the patient's breast reconstruction site. A 10cm long 16-guage needle is provided to aid insertion of the catheter into the patient. The entire catheter will pass through the bore of the introducer needle. A 60cc syringe is used to fill the Symbios GOPump through the fill port. After filling the 60cc syringe with up to 300cc of normal saline, the syringe is attached to the port and the medication injected into the infusion pump. The steady-flow pressure regulator maintains a constant 6 psi pressure in the outflow chamber ensuring a uniform flow of medication through each catheter inserted into the Symbios GOPump.
Drug: Saline
Up to 300cc of normal saline administered to the mastectomy site via 2 catheters connected to the Symbios GOPump at a rate of 2 cc per hour per catheter over 3 days.
Other Name: Normal Saline

Detailed Description:

Double-blind, randomized, controlled clinical trial comparing patient-reported pain and pain medication/narcotic use between patients randomized to treatment (bupivacaine) or placebo (saline) delivered via pain pump to the mastectomy site. Candidates will have elected to undergo unilateral post-mastectomy immediate tissue expander breast reconstruction. Participants meeting inclusion criteria will be enrolled and baseline data collection completed prior to randomization and surgery.

Patients will be randomized 1:1 to bupivacaine- (treatment) or saline-(placebo) filled percutaneously-placed pain pumps in a double-blinded design. Patient-specific surgical details will be recorded intraoperatively. Following the surgery, post-operative pain, pain medication/narcotic use, and assessment for adverse events (AEs)/serious adverse events (SAEs) will be assessed on Days 1, 2, and 3. A clinic visit occurs on Day 7 when the pain pump will be removed and additional data collected (updated medical history, pain medication/narcotic use, AEs/SAEs, and study questionnaires). A Pain Pump Questionnaire will be completed to obtain the patient's assessment of the usability of the pain pump.

Long-term quality-of-life/health outcomes assessments will be done on post-operative Day 90 (±14 days), Year 2 (±14 days), and Year 4 (±14 days). The Year 2 and Year 4 follow-ups are included as tertiary endpoints to capture differences in chronic pain, and patients will be asked to complete the same questionnaires as at the Day 90 follow up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be Female aged 18-100 years.
  • Choose unilateral mastectomy followed by immediate tissue expander breast reconstruction.
  • Have no inflammatory breast cancers.
  • Be aware of the nature of her malignancy.
  • Understand the study purpose, requirements, and risks.
  • Be able and willing to give informed consent.

Exclusion Criteria:

  • Any concurrent narcotic analgesic use (baseline narcotic use must be 0 to be eligible).
  • Axillary lymph node dissection related to qualifying mastectomy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494259

Locations
United States, Maryland
Dept. of Plastic and Reconstructive Surgery, Johns Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Carisa M Cooney, MPH    443-287-4629    ccooney3@jhmi.edu   
Principal Investigator: Gedge Rosson, MD         
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Gedge Rosson, Associate Professor, Dept. of Plastic and Reconstructive Surgery; Director of Breast Reconstruction, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01494259     History of Changes
Other Study ID Numbers: NA_00010363
Study First Received: December 13, 2011
Last Updated: December 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
immediate breast reconstruction
pain control
post mastectomy pain control
Post mastectomy pain control

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Epinephrine
Bupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 22, 2014