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

Stopped early · Phase 3

Conditions studied: Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life

In brief

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.

Key facts

Study ID: NCT02161705
Run by: Johns Hopkins University
People needed: 18
Starts: 2014-07-01
Expected to finish: 2019-02-01
Last updated by the study team: 2020-04-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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).

Where it is running

Johns Hopkins University School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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