Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial

Launched by MONASH UNIVERSITY · Oct 3, 2021

Keywords

ClinConnect Summary

The LOLIPOP Trial is studying the long-term effects of lidocaine infusions on pain management after breast surgery, specifically for women who are having mastectomies or breast-conserving surgeries due to breast cancer. This research aims to determine if lidocaine, a medication used to numb pain, can improve recovery and reduce post-operative pain compared to a placebo (which looks like the treatment but has no active ingredients). The trial is taking place in various locations around the world and includes about 4,300 participants.

To participate in this trial, women aged 18 and older who are undergoing surgery for breast cancer may be eligible, provided they do not have certain medical conditions that could complicate their treatment, such as pre-existing pain in the surgery area or serious heart issues. Participants will receive either lidocaine or a placebo during their procedure and will be monitored for their recovery and pain levels over time. This trial is an important step in finding safer and more effective pain management strategies for women undergoing breast cancer surgeries.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for the primary excision of confirmed or suspected breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants).
• • American Society of Anaesthesiologist (ASA) physical scale 1-3
• Exclusion Criteria:
• • Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm
• • Re-excision procedures where the margins at the index surgery have been deemed insufficient
• • When immediate autologous reconstruction surgery is planned
• • Where delayed autologous reconstruction surgery on the operative breast within one year is planned
• • Planned use of regional analgesia infusions
• • Impaired cognition
• • Pregnant or lactating females
• • Transgender patients
• • Known metastatic disease
• • History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patients with porphyria or methaemoglobinaemia
• • History of epilepsy
• • Baseline heart rate \< 50 bpm or systolic blood pressure \< 100mmHg.
• • Acute coronary event in the last three months
• • Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated
• • Abnormal serum potassium concentration (based upon site laboratory reference ranges)
• • Abnormal serum sodium concentration (based upon site laboratory reference ranges)
• • Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes)
• • Medications within the last 7 days which are known / suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs)
• • Cardiac Failure (any documented heart failure at peroperative assessment or GP records)
• • Severe Renal Failure (Creatinine Clearance of less than 30ml/min or dialysis dependent)
• • Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches