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Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block in MRM

Comparison Between Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block on Postoperative Analgesia for Patients Undergoing Modified Radical Mastectomy: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06404918
Enrollment
70
Registered
2024-05-08
Start date
2023-01-22
Completion date
2024-04-03
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Modified Radical Mastectomy

Keywords

Erector Spinae Plane Block, Serratus Anterior Plane Block

Brief summary

Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.

Detailed description

Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period. Inadequate pain management has both psychological and physiological repercussions. Various local or regional nerve blocks like thoracic epidural, interscalene brachial plexus, paravertebral, pectoral nerve blocks, and erector spinae plane blocks are performed in MRM to provide analgesia. Ultrasound-guided Erector spinae plane block (USG-ESPB) is one of the novel and effective regional techniques where local anaesthetic is deposited deep into the erector spinae muscle, blocking the ventral and dorsal rami of multiple spinal nerves, and is technically simple, with fewer hemodynamic side effects and with minimal complications

Interventions

PROCEDUREErector spinae plane group

The patients were placed in lateral decubitus position with the operation site up. The probe was placed vertically 3 cm lateral to the T5 spinous process, and the transverse process was identified as an oval hyperechoic sonographic structure. The needle was introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. 0.5 mL of normal saline was injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. A total of 0.4 mL kg-1 of 0.25% bupivacaine was injected. between the erector spinae muscle and transverse process.

PROCEDURESerratus anterior plane group

Serratus anterior plane block was administered to patient in the supine position with ipsilateral arm abducted to 90°. Under aseptic precautions, linear probe was placed over the midclavicular region in the sagittal plane. Ribs were counted inferiorly and laterally until the fifth rib was identified in midaxillary line. Latissimus dorsi, teres major, and serratus anterior muscles were identified overlying the fifth rib. The intended puncture site was infiltrated with 2 mL of 2% lignocaine, and using ultrasound-guided in-plane approach, the needle was introduced in caudal to cranial direction until the tip was placed between the serratus anterior muscle and external intercostal muscle.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Masking description

The patients and Care Provider in this trial were blinded

Intervention model description

Group I (35 patients): patients received US ESPB and group II (35 patients): patients received USAPB.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* female patients * aged from 18 to 70 years * with a body mass index ≤ 30 kg/ m2 * American Society of Anesthesiologists (ASA) physical status I-II, * who were scheduled for MRM for breast cancer

Exclusion criteria

* history of drug allergy, * psychiatric illness, substance abuse, * severe cardiovascular or respiratory disease, * any pre-existing liver disease, metabolic or neurological syndrome, c

Design outcomes

Primary

MeasureTime frameDescription
time of the first rescue analgesic dose24 hours postoperativelyThe time when the first dose of rescue analgesia was administered at the recovery room,

Secondary

MeasureTime frameDescription
Heart rate changes15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.Heart rate (HR) was recorded immediately before induction of anaesthesia, 1
Mean arterial pressure changes15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.Mean arterial pressure

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026