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

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.

Conditions

• Postoperative Pain
• Postoperative Nausea and Vomiting
• Quality of Life

Interventions

DRUG

Ropivacaine

0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block

DRUG

Saline

Up to 0.8 mL/kg of normal saline administered

Sponsors & Collaborators

• The Plastic Surgery Foundation

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Gedge D Rosson, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2018-04-30

Completion

2019-02-28

Countries

• United States

Study Locations