The objective of the PLAN study was to assess the impact of an intraoperative intravenous lidocaine infusion and perioperative oral pregabalin to prevent the development of post-mastectomy pain syndrome.

Primary endpoints:

  • To 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.

  • To determine the impact of an IILI and perioperative oral pregabalin in breast cancer surgery on:

1. Acute postoperative NRS pain scores and 24 hour morphine-equivalent opioid consumption for the first three days after surgery

2. Length of hospital stay

3. Post-mastectomy pain syndrome (PMPS) at three months after surgery, and;

4. Scores on the SF-MPQ-2, BPI, and SF-36 at three months after surgery.

Study Type

Interventional - Drug

Study Design

Blinded 2X2 factorial RCT

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2014 - 2016



Hamilton Academic Health Sciences Organization (HAHSO)

Physicians' Services Incorporated Foundation (PSI)

Back To Top