The goal of this clinical trial is to learn whether an intravenous lidocaine infusion (IVLI) works as well as a thoracic paravertebral block (TPVB) - the current standard nerve-block technique - for improving recovery after breast cancer surgery. It will also learn about the safety of both approaches. The main questions it aims to answer are:
Does IVLI provide a similar quality of recovery (measured by the QoR-15 score at 24 hours) as TPVB? Does IVLI control pain during the first 24 hours after surgery (measured at rest and with arm movement) as well as TPVB?
Participants will:
Undergo their planned breast cancer surgery (mastectomy or breast-conserving surgery with sentinel lymph node biopsy) under general anaesthesia, along with either the TPVB injection or the IVLI infusion, assigned at random Attend a preoperative visit the day before surgery to learn how to use the pain and self-quality-of-recovery questionnaire (QoR-15) Fill out a QoR-15 once a day for the first 48 hours after surgery Participants' pain score in hospital recorded during the first 48 hours after surgery, with rescue pain medication available if needed
Adult ASA I-III patients between the age 18 to 75 years scheduled for primary breast cancer surgery-simple mastectomy and modified radical mastectomy with sentinel lymph node biopsy +/- axillary dissection.
Patient refusal, patients unable to comprehend QoR15 form, total body weight less than 40 Kg, local skin site infection, coagulopathy, history of allergy to local anaesthetics, and patients with hepatic, renal and cardiac dysfunction will be excluded.
Parallel
TPVB
Procedure/SurgerySingle shot thoracic paravertebral block with 0.5% Ropivacaine plus adrenaline 5 mcg/ml (total mixture 25 ml)
IV Lidocaine infusion
DrugPatients receiving IV Lidocaine infusion of 1.5 mg/kg in 10 mins then continue 1.5mg/kg/h (= 0.075ml/kg in 10 mins then 0.075ml/kg/h) intraoperatively
sham subcutaneous infiltration
Procedure/Surgery2% Lidocaine 1-2 ml subcutaneously infiltrate to blind the patients and outcome assessor
IV placebo infusion
Druginfusion of normal saline at a same rate as IV LI (0.075ml/kg in 10 mins then 0.075ml/kg/h)
Quality of recovery 15 (QoR15) score at 24 hours
Patient-reported QoR 15 at 24-hour and 48-hour postoperative
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This trial is not recruiting at the moment. You can still explore other options:
