Quality of Recovery After Primary Breast Cancer Surgery Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.

NCT07823244 | Not Yet Recruiting

• 1 other identifier: 102/2569(IRB4)
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Pain Management After Major Breast Surgery; Well Being After Major Breast Surgery

Outcome Measures

Primary Outcomes (1)

• Quality of recovery 15 (QoR15) score at 24 hours

  Patient-reported QoR 15 at 24-hour and 48-hour postoperative

  From enrollment to 48 hours postoperatively

Study Arms (2)

TPVB

ACTIVE COMPARATOR

US guided TPVB

Procedure: TPVB; Drug: IV placebo infusion

IV LI

EXPERIMENTAL

IV Lidocaine infusion

Drug: IV Lidocaine infusion; Procedure: sham subcutaneous infiltration

Interventions

TPVB PROCEDURE

Single shot thoracic paravertebral block with 0.5% Ropivacaine plus adrenaline 5 mcg/ml (total mixture 25 ml)

TPVB

IV Lidocaine infusion DRUG

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

IV LI

sham subcutaneous infiltration PROCEDURE

2% Lidocaine 1-2 ml subcutaneously infiltrate to blind the patients and outcome assessor

IV LI

IV placebo infusion DRUG

infusion of normal saline at a same rate as IV LI (0.075ml/kg in 10 mins then 0.075ml/kg/h)

TPVB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Study Officials

• Chayapa Luckanachanthachote, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chayapa Luckanachanthachote

CONTACT

+66 928266963; chayapa.anes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)