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

The Chinese University of Hong Kong

Status: Completed

Conditions: Breast Neoplasms

Treatments: Drug: USG ESPB; Drug: Intravenous Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06490718

CREC 2024.055-T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Group ESPB

Active Comparator group

Description:

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.

Treatment:

Drug: USG ESPB

Group IVLI

Experimental group

Description:

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.

Treatment:

Drug: Intravenous Infusion