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Research

Photo for PLAN

PLAN

Official Title

Pregabalin and Lidocaine in breast cancer surgery to Alter Neuropathic pain (PLAN): A Pilot Trial

Status

Ongoing

Overview

To assess the impact of an intraoperative intravenous lidocaine infusion and perioperative oral pregabalin to prevent the development of post-mastectomy pain syndrome

Study Design

Randomized controlled, 2X2 factorial, blinded, multicentre trial.

Primary Endpoint

1) Determine among patients undergoing breast cancer surgery: 1. the feasibility of recruiting patients into a larger factorial randomized controlled trial (RCT) of intraoperative intravenous lidocaine infusion (IILI) vs. placebo and perioperative pregabalin vs. placebo for the prevention of post-mastectomy pain syndrome; 2. the time, resources, and management issues related to conducting a larger trial; and 3. Clinical site compliance with trial protocol. 2) Determine the impact of an IILI and perioperative oral pregabalin in breast cancer surgery on: acute postoperative NRS pain scores and 24 hour morphine-equivalent opioid consumption for the first three days after surgery; length of hospital stay; post-mastectomy pain syndrome (PMPS) at 3 months after surgery; and scores on the SF-MPQ-2, BPI, and SF-36 at 3 months after surgery.

Number of Patients

100

Number of Sites

2

Number of Countries

1

Study Period

2014–2015

Principal Investigator

P.J. Devereaux

Program Manager

Shirley Pettit

Research Coordinator

Kayla Pohl