anaesthetic & critical care studies summaries

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Protocol v6.0 24/03/2025
Rotherham Principal Investigator: Professor Anil Hormis
Sub Investigator: Miss Bertha In 'T Hout
Associate PI: Dr Rick Harrold
Research team member: Cheryl Graham

research topic:

Evaluate the effectiveness of IV lidocaine infusions peri-operatively on the incidence of moderate or severe chronic post-surgical pain one year post-op in elective primary surgeries for breast cancer.

trial groups:

IV 2% lidocaine infusion OR placebo

​A bolus of the study drug, 0.125 ml/kg of lean body weight (LBW) of 2% lidocaine (2.5 mg/kg (LBW) OR matched placebo) to be administered after anaesthetic induction, but prior to surgical incision, followed by an intraoperative intravenous infusion, 0.1665 ml/kg (LBW)/h of 2% lidocaine (3.33 mg/kg (LBW)/h or matched placebo).

The IV infusion stops 1 hour post-op, when fit to leave theatre recovery, or when the syringe runs out - whichever is soonest.

​There will be simple un-blinding instructions available.

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 GA (including those with simultaneous in insertion of tissue expanders or implants).
  
• ASA score 1-3

exclusion criteria:

• Pre-existing pain at the site of surgery
• Re-excision procedures or complex reconstructions
• Regional analgesia infusions
• History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents), including patients with known porphyria or methaemoglobinaemia
• Plus more exclusion criteria than can be listed here such as: cardiac conductions abnormalities, cardiac failure, severe renal failure and more.

consent:

Patients will be consented ahead of surgery date and drug collected by research team and given to the list anaesthetist with patient specific weight dosage instructions.

A member of the research team will discuss with you ahead of the list starting.

​Prof Anil Hormis, Miss Bertha In ‘T Hout and Dr Rick Harrold are leading the trial