Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    1150
  • sponsor
    University Health Network, Toronto
Updated on 12 March 2022
anesthesia
cancer
lidocaine
mastectomy
lumpectomy
mammogram

Summary

Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.

Description

PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,150 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes

Details
Condition Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic
Treatment Placebo, Lidocaine 20mg/ml
Clinical Study IdentifierNCT04874038
SponsorUniversity Health Network, Toronto
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18 years old
Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)

Exclusion Criteria

Previous breast surgery within 6 months of index surgery
Undergoing any autologous flap procedure during index surgery
Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
Documented hypersensitivity or allergy to lidocaine
Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)
History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
Known cirrhotic liver disease
Pregnant
Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
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