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Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain

Primary Purpose

Pain

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Saline
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring immediate breast reconstruction, pain control, post mastectomy pain control

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Plastic and Reconstructive Surgery, Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bupivacaine (Treatment) Group

Saline (Placebo) Group

Arm Description

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.

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.

Outcomes

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.
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.
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.
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.
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.

Full Information

First Posted
December 13, 2011
Last Updated
October 9, 2015
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01494259
Brief Title
Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
immediate breast reconstruction, pain control, post mastectomy pain control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine (Treatment) Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline (Placebo) Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine with epinephrine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
Day of Surgery through Day 7
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Day 90
Title
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.
Description
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.
Time Frame
Year 2
Title
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.
Description
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.
Time Frame
Year 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Dept. of Plastic and Reconstructive Surgery, Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain

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