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Trial Title:
Comparing Quality of Recovery Between ESPB and IV Lidocaine After Major Breast Cancer Surgery
NCT ID:
NCT06490718
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Erector spinae plane block
Intravenous lidocaine infusion
Breast cancer surgery
Quality of recovery
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective, multicenter, randomized, triple-blind trial
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Triple blind
Intervention:
Intervention type:
Drug
Intervention name:
USG ESPB
Description:
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%
levobupivacaine 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.
Arm group label:
Group ESPB
Intervention type:
Drug
Intervention name:
Intravenous Infusion
Description:
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.
Arm group label:
Group IVLI
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Xia Feng, Md, PhD
Email:
fengxia@mail.sysu.edu.cn
Facility:
Name:
North District Hospital
Address:
City:
Sheung Shui
Zip:
999077
Country:
Hong Kong
Contact:
Last name:
Manoj K Karmakar, MD, FRCA
Email:
karmakar@cuhk.edu.hk
Start date:
August 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06490718
