Life sciences · Interventional Study
ClinicalTrials.gov · September 16, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07823244). This is a study registration, not published results. Lead sponsor: Mahidol University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 112 participants (ESTIMATED). Conditions: Pain Management After Major Breast Surgery, Well Being After Major Breast Surgery. Interventions: PROCEDURE: TPVB; DRUG: IV Lidocaine infusion; PROCEDURE: sham subcutaneous infiltration; DRUG: IV placebo infusion. Primary outcome measures: Quality of recovery 15 (QoR15) score at 24 hours , From enrollment to 48 hours postoperatively. Brief summary: 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