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

Quality of Recovery After Major Breast Cancer Surgery: a Prospective Multicentre Randomized Triple Blinded Trial Comparing Erector Spinae Plane Block and Intravenous Lidocaine Infusion

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Intravenous Infusion; Drug: USG ESPB

Detailed Description

Major Breast Cancer Surgery (BCS), including mastectomy or modified radical mastectomy (MRM), is a globally prevalent procedure. Unfortunately, it is associated not only with significant acute postoperative pain but also a high incidence of chronic postsurgical pain (30-50%) . To improve outcomes, regional anesthetic techniques have been explored, including thoracic paravertebral block (TPVB) and ultrasound-guided erector spinae plane block (ESPB). While TPVB is considered the gold standard, it carries potential complications such as pleural puncture and pneumothorax. In contrast, ultrasound-guided (USG) ESPB is gaining popularity due to its technical simplicity and safety. However, controversy surrounds its mechanism of action, particularly the variable cutaneous sensory loss over anterior thoracic dermatomes. An emerging theory suggests that ESPB's clinical analgesia results from rapid and sustained local anesthetic (LA) absorption from the injection site. As an alternative, intravenous LA infusion (IVLI) during the perioperative period may offer equivalent analgesia without the invasiveness of ESPB. IV lidocaine, known for its substantial analgesic properties, persists beyond its typical duration of action, likely through mechanisms beyond sodium channel blockade. Although IV lidocaine has been established as part of multimodal analgesia in various perioperative settings, data specific to major BCS remain scarce. In this prospective, multicenter, randomized, triple-blind trial, the investigators aim to compare quality of recovery (assessed using the validated Quality of Recovery 15 [QoR15] score) between USG ESPB and IVLI. The investigator's hypothesis is that the quality of recovery after major breast cancer surgery with IVLI will be comparable to that achieved with USG ESPB.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital
• Hong Kong
  • Sheung Shui, Hong Kong, 999077
    • North District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA I-III patients
• 18 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group IVLI; 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; 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.
Active Comparator: Group ESPB; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid consumption	Total postoperative morphine equivalent consumption	At 24 and 48 hour post surgery

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Manoj K Karmakar, MD, FRCA, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Actual): July 17, 2025
• Study Completion (Actual): July 20, 2025

Study Registration Dates

• First Submitted: June 29, 2024
• First Submitted That Met QC Criteria: June 29, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Erector spinae plane block; Quality of recovery; Breast cancer surgery; Intravenous lidocaine infusion
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Administration, Intravenous; Infusions, Parenteral; Infusions, Intravenous
• Other Study ID Numbers: CREC 2024.055-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No