Clinical trial NCT06490718: Comparing Quality of Recovery Between ESPB and IV Lidocaine After Major Breast Cancer Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Keywords: Erector spinae plane block
Intravenous lidocaine infusion
Breast cancer surgery
Quality of recovery
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, randomized, triple-blind trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery
timeFrame: At 24 hours post surgery
measure: Area under the curve of postoperative pain
timeFrame: Over the first 24 hours post surgery
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: At 24 and 48 hour post surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital
state: Guangdong
city: Sheung Shui
country: Hong Kong
facility: North District Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Manoj K Karmakar, MD, FRCA
role: PRINCIPAL_INVESTIGATOR
References: