Study Type
Interventional - Drug
completed
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 Design
Blinded 2X2 factorial RCT
NO. of Countries
1
NO. of Sites
2
NO. of Participants
100
Study Period
2014 - 2016
Sponsor
PHRI
PJ Devereaux
Deputy Director, Senior Scientist
PJ Devereaux
Deputy Director, Senior Scientist
Devereaux is a cardiologist, perioperative care physician, and clinical epidemiologist. He is the Director of the Division of Perioperative Care at McMaster University and a Deputy Director, Senior Scientist, and Scientific Leader of the Anesthesiology, Perioperative Medicine, and Surgical Research Group at PHRI. He is the Nominated Principal Applicant of the Accelerating Clinical Trials (ACT) Consortium, which is the Pan-Canadian Clinical Trials Consortium funded by the Canadian Institutes of Health Research (CIHR). Additionally, he holds a Tier 1 Canadian Research Chair in Perioperative Medicine.
Devereaux is a full Professor at McMaster University and the President of the Society of Perioperative Research and Care. He has published over 450 peer-reviewed papers and more than 85 book chapters, editorials, and commentaries, including 17 in the New England Journal of Medicine, 13 in the Lancet, and 11 in JAMA. He has an h-index of 115 and has given over 1000 lectures and research presentations in 41 countries. His research program focuses on major vascular complications during and after surgery, and he has led many large international randomized trials and prospective cohort studies on this topic.
