Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction

• Status: Terminated
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Primary Objective To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.

Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of surgery while the patient is still hospitalized (post-operative day 0). This will be patient-provided data. Unblinded data analysis will compare scores between treatment and control groups.

Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea, and sleep interference differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.

Pain score, opioids use, nausea, and sleep interference data will be collected via patient self-report. When possible (i.e., while hospitalized) objective data on opioids and other pain medication administered to the patient will be used.

Tertiary Objectives To determine if long-term changes in Quality of Life scores [the RAND-36 Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and Breast-Q scores] differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.

This data will be collected via validated questionnaires through patient interviews at 3-months, 2-years, and 4-years (±14 days) after surgery.

Once enrolled in the study, participants will be encouraged to remain in the study for the 4 years following surgery in order to get final pain scores and quality-of-life/health outcome survey information. Participants who cannot be contacted after several phone attempts and the sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year outcome assessments will be considered lost to follow-up.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Plastic Surgery Educational Foundation; The Plastic Surgery Foundation
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• Be Female aged 18-100 years.

• Choose mastectomy followed by bilateral 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 opioid analgesic use (baseline opioid use must be 0 to be eligible).

• Liver dysfunction and/ or cirrhosis.

• Renal insufficiency, with creatinine greater than 1.5 mg/mL.

• Patients weighing less than 50 Kg.

• Concurrent use of the SSRI antidepressant fluvoxamine (Luvox).