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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
112
Single shot thoracic paravertebral block with 0.5% Ropivacaine plus adrenaline 5 mcg/ml (total mixture 25 ml)
Patients 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
2% Lidocaine 1-2 ml subcutaneously infiltrate to blind the patients and outcome assessor
infusion of normal saline at a same rate as IV LI (0.075ml/kg in 10 mins then 0.075ml/kg/h)
Mahidol University
Bangkok Noi, Bangkok, Thailand
Quality of recovery 15 (QoR15) score at 24 hours
Patient-reported QoR 15 at 24-hour and 48-hour postoperative
Time frame: From enrollment to 48 hours postoperatively
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