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NCT Number: NCT06490718

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Quality of Recovery

    Time frame: At 24 hours post surgery

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

  2. Area under the curve of postoperative pain

    Time frame: Over the first 24 hours post surgery

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

Secondary outcomes

  1. Postoperative opioid consumption

    Time frame: At 24 and 48 hour post surgery

    Total postoperative morphine equivalent consumption

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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