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

Quality of Recovery After Primary Breast Cancer Surgery: A Prospective, Multicentre, Randomized, Triple-Blinded Trial Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07823244

Enrollment

112

Registered

2026-09-16

Start date

2026-10-01

Completion date

2029-09-30

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

PROCEDURETPVB

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

DRUGIV Lidocaine infusion

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

PROCEDUREsham subcutaneous infiltration

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

DRUGIV placebo infusion

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Quality of recovery 15 (QoR15) score at 24 hours	From enrollment to 48 hours postoperatively	Patient-reported QoR 15 at 24-hour and 48-hour postoperative

Countries

Thailand

Contacts

CONTACTChayapa Luckanachanthachote

chayapa.anes@gmail.com+66 928266963

PRINCIPAL_INVESTIGATORChayapa Luckanachanthachote, MD

Mahidol University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026