Comparing Quality of Recovery Between ESPB and IV Lidocaine After Major Breast Cancer Surgery

NCT06490718 | Completed

• 1 other identifier: CREC 2024.055-T
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

The erector spinae plane block (ESPB) is gaining popularity as a regional anesthetic technique for major breast cancer surgery. Although there is controversy about its mechanism of action, emerging evidence suggests that clinical analgesia observed after ESPB in breast surgery may be due to rapid and sustained local anesthetic absorption from the injection site. Hence intravenous LA infusion (IVLI) during the perioperative period could offer an effective alternative to invasive ESPB.

Conditions

Breast Neoplasms

Keywords

Erector spinae plane block; Intravenous lidocaine infusion; Breast cancer surgery; Quality of recovery

Outcome Measures

Primary Outcomes (2)

• Quality of Recovery

  Quality of Recovery-15: a minimum score of 0 (poor recovery) and a maximum score of 150 (excellent recovery)

  At 24 hours post surgery

• Area under the curve of postoperative pain

  Area under the curve of postoperative pain numerical rating score at rest and movement

  Over the first 24 hours post surgery

Secondary Outcomes (1)

• Postoperative opioid consumption

  At 24 and 48 hour post surgery

Study Arms (2)

Group ESPB

ACTIVE COMPARATOR

For USG ESPB, 25 ml of 0.5% ropivacaine with 1:200,000 adrenaline will be drawn in a 25 ml syringe with a sterile label (available in a sterile package) displaying 'study drug for ESPB'. For IV infusion, 30 ml 0.9% saline will be drawn in a 50 ml syringe with a sterile label displaying 'study drug for IVI'. Both these syringes will be stored under strict aseptic precautions in a sterile tray until administration.

Drug: USG ESPB

Group IVLI

EXPERIMENTAL

For USG ESPB, 25 ml of 0.9% saline will be drawn in a 25 ml syringe with a sterile label (available in a sterile package) displaying 'study drug for ESPB'. For IV infusion, 30 ml 2% lidocaine will be drawn in a 50 ml syringe with a sterile label displaying 'study drug for IVI'. Both these syringes will be stored under strict aseptic precautions in a sterile tray until administration. The 30 ml volume for 2% lidocaine is decided as it can cover for a 70kg patient for a 3-hour surgical period.

Drug: Intravenous Infusion

Interventions

USG ESPB DRUG

After obtaining the appropriate sonographic window, under strict aseptic precautions, the block needle is inserted in the plane of the US beam in a caudad to cranial direction until the tip is in contact with the transverse process (TP) at its lateral aspect. A test bolus of 0.9% saline (1-2 ml) is injected and sonographic evidence of erector spinae muscle displacement (posterior) from the underlying TP is sought to ensure that the tip of the block needle is indeed at the erector spinae muscle plane. The study drug from the 25 ml syringe with the label 'study drug for ESPB' (containing either 25 ml of 0.5% ropivacaine with 1:200,000 adrenaline or 0.9% saline depending on the group allocation) is injected in small aliquots over a minute. The anaesthesiologist performing the block and the patient is blinded to the group allocation. Successful injection reveals a clearly delineated posterior displacement of the erector spinae muscle.

Group ESPB

Intravenous Infusion DRUG

Following ultrasound-guided erector spinae plane block (USG ESPB), patients will be transferred to the operating room. General anesthesia (GA) will be administered according to a standardized protocol. Study Drug Infusion: Immediately after securing the airway, an intravenous infusion from a 50 ml syringe labeled "study drug for IVI" will commence. The study drug contains either 30 ml of 2% lidocaine or 0.9% saline, depending on group allocation. The infusion begins with a bolus rate of 0.1 ml/kg over 10 minutes and continues at 0.1 ml/kg/hr until surgical wound closure.

Group IVLI

Eligibility Criteria

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

You may qualify if:

• ASA I-III patients
• to 75 years of age
• Patients scheduled for primary breast cancer surgery-mastectomy, modified radical mastectomy and breast conservation surgery with sentinel lymph node biopsy +/- axillary dissection will be included in this study.

You may not qualify if:

• Patient refusal,
• Local skin site infection,
• Coagulopathy,
• History of allergy to local anaesthetics, and
• Patients with hepatic, renal and cardiac dysfunction

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

The First Affiliated Hospital

Guangzhou, Guangdong, China

Location

North District Hospital

Sheung Shui, 999077, Hong Kong

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Infusions, Intravenous

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Manoj K Karmakar, MD, FRCA

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, multicenter, randomized, triple-blind trial

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: October 25, 2024
• Primary Completion: July 17, 2025
• Study Completion: July 20, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-04

Locations

HK (1); CN (1)