Pain Management After Major Breast SurgeryNCT07823244
Quality of Recovery After Primary Breast Cancer Surgery Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.
A study testing TPVB and IV Lidocaine infusion in people with Pain Management After Major Breast Surgery and Well Being After Major Breast Surgery, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Management After Major Breast Surgery, Well Being After Major Breast Surgery
- What is being tested?
- TPVB and IV Lidocaine infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Mahidol University
Bangkok Noi, Bangkok, 10700
Mahidol University
About this study
Official title: Quality of Recovery After Primary Breast Cancer Surgery: A Prospective, Multicentre, Randomized, Triple-Blinded Trial Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.
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?
Read more
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
- Being tested
- TPVB, IV Lidocaine infusion, sham subcutaneous infiltration, IV placebo infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPVBProcedure or surgery
Single shot thoracic paravertebral block with 0.5% Ropivacaine plus adrenaline 5 mcg/ml (total mixture 25 ml)
IV Lidocaine infusionDrug
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
sham subcutaneous infiltrationProcedure or surgery
2% Lidocaine 1-2 ml subcutaneously infiltrate to blind the patients and outcome assessor
IV placebo infusionDrug
infusion of normal saline at a same rate as IV LI (0.075ml/kg in 10 mins then 0.075ml/kg/h)
| Study group | Role | What they receive |
|---|---|---|
| TPVB | Active comparator | US guided TPVB Receives: Procedure: TPVB; Drug: IV placebo infusion |
| IV LI | Experimental | IV Lidocaine infusion Receives: Drug: IV Lidocaine infusion; Procedure: sham subcutaneous infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery 15 (QoR15) score at 24 hours
Patient-reported QoR 15 at 24-hour and 48-hour postoperative
Measured: From enrollment to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Management After Major Breast SurgeryStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chayapa Luckanachanthachote, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823244
- Sponsor's protocol ID
- 102/2569(IRB4)
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery After Primary Breast Cancer Surgery: A Prospective, Multicentre, Randomized, Triple-Blinded Trial Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.
- ClinicalTrials.gov ID
- NCT07823244
- Acronym / sponsor ID
- 102/2569(IRB4)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPVB | Active comparator | Procedure: TPVB, Drug: IV placebo infusionUS guided TPVB |
| IV LI | Experimental | Drug: IV Lidocaine infusion, Procedure: sham subcutaneous infiltrationIV Lidocaine infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPVBSingle shot thoracic paravertebral block with 0.5% Ropivacaine plus adrenaline 5 mcg/ml (total mixture 25 ml) | Procedure or surgery | TPVB |
| IV Lidocaine infusionPatients 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 | Drug | IV LI |
| sham subcutaneous infiltration2% Lidocaine 1-2 ml subcutaneously infiltrate to blind the patients and outcome assessor | Procedure or surgery | IV LI |
| IV placebo infusioninfusion of normal saline at a same rate as IV LI (0.075ml/kg in 10 mins then 0.075ml/kg/h) | Drug | TPVB |
Primary outcome
Quality of recovery 15 (QoR15) score at 24 hours
Time frame: From enrollment to 48 hours postoperatively
Patient-reported QoR 15 at 24-hour and 48-hour postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chayapa Luckanachanthachote, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPVB and IV Lidocaine infusion in people with Pain Management After Major Breast Surgery and Well Being After Major Breast Surgery, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chayapa Luckanachanthachote (+66 928266963, chayapa.anes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery 15 (QoR15) score at 24 hours (time frame: From enrollment to 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.