Erector Spinae Plane Block Versus Local Wound Infiltration After Modified Radical Mastectomy

Not Applicable

Recruiting

• Conditions: Post Operative Pain; Local Infiltration; Erector Spinae Plane Block
• Interventions: Procedure: local wound infiltration; Procedure: Erector spinae plane block

• Registration Number: NCT06533566
• Lead Sponsor: Tanta University

Brief Summary

This randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided Erector Spinae plane block and local wound infiltration (drain block) for patients scheduled for modified radical mastectomy surgery.

Detailed Description

Breast cancer is the most commonly diagnosed cancer worldwide and it represents 1 in 4 cancers diagnosed among women globally. Modified Radical Mastectomy (MRM) is a commonly performed surgery for breast cancer and is associated with moderate-to-severe postoperative pain. Poor postoperative pain management can lead to increased chances of the development of chronic pain. Therefore, adequate postoperative pain management after breast cancer surgery is essential. Regional block for pain management has many advantages in such patients including provision of adequate analgesia, reduced need for opioids, decreased postoperative nausea \& vomiting and postoperative pulmonary complications. It also facilitates early ambulation. Thoracic Epidural (TE), paravertebral block (PVB), pectoral nerve I \& pectoral nerve II blocks, serratus anterior plane block and erector spinae plan block have been used with good results. In particular, the erector spinae has proven to reduce pain severity and opioid consumption in this group of patients. Further, in meta-analysis, the ESP block was shown to effectively alleviate postoperative pain severity and reduce opioid consumption. In ESP block, local anesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerves. The LA diffuses into the paravertebral space and cephalo-caudally and blocks the pain by action on dorsal rami, ventral rami, and lateral cutaneous branches of intercostal nerves. Also, in many situations, a superior postoperative analgesia yet avoiding the detrimental effects of opioids, can be extracted from a simple technique of wound instillation of local anesthetics through surgical drain which provide a satisfactory long opioid free postoperative analgesic period.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Study Start: 2024-08-10
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• American Society of Anesthesiology (ASA) physical status I-II
• scheduled for unilateral Modified radical mastectomy

Read More

Exclusion Criteria

• Patient refusal.
• Patient with neurological deficit.
• Patient with bleeding disorders.
• Uncooperative patient.
• Infection at the block injection site.
• Patients with history of allergy to local anesthetics.
• Advanced hepatic, cardiac or renal failure.
• Chronic opioid consumption.
• Body mass index (BMI)≥ 30 kg m-2
• Chronic use of gabapentin or pregabalin

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drain block	local wound infiltration	Patients of this group will receive local wound infiltration (drain block) with injection of (20 ml) of plain bupivacaine 0.25% (max dose 2mg/kg) injected in each surgical drain (pectoral and axillary drains) thereafter, the drains would then clamped for 20 minutes and declamped later on.
Erector Spinae Block	Erector spinae plane block	Patients of this group will receive ultrasound guided erector spinae block with injection of (20 ml) of plain bupivacaine 0.25% (max dose 2mg/kg) injected beneath the erector spinae muscle sheath at the level of the fourth transvers process (T4).

Primary Outcome Measures

Name	Time	Method
total morphine consumption	first postoperative day after modified radical mastectomy surgery	total morphine amount which will be consumed in the first postoperative day

Trial Locations

Locations (1)

Faculty of medicine, Tanta university; 🇪🇬 Tanta, El Gharbyia, Egypt