Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia

Not Applicable

Completed

• Conditions: MASTECTOMY
• Interventions: Procedure: Deep serratus anterior plane block; Procedure: Erector spina plain block for mastectomy analgesia

• Registration Number: NCT04108715
• Lead Sponsor: King Saud University

Brief Summary

Breast cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Respiratory depression, Ileus, sedation, nausea and vomiting are some of the potential side effect of opioid treatment which prolonged hospital length of stay and increase the coast. Recent advance in ultrasound guided regional anesthesia has led to the development of two novel regional anesthesia techniques specific to chest wall analgesia; Erector spina plain block and Serratus anterior plain block, with its potential to reduce or eliminate the need for opioids to manage post-operative pain.

Detailed Description

Experimental: erector spinae plain block After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, and prepping para-spinous area with antiseptic solution. Ultrasound high frequency linear transducer is positioned in a para-sagittal plane at the level of fifth thoracic vertebra. Scanning of interested structures from superficial to deep planes, Trapezius muscle, Rhomboid major muscle, Erector spina muscle and transverse process of fifth thoracic vertebra.

Comparator: serratus anterior plane block After giving general anesthesia, patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. Under sterile aseptic technique, a linear ultrasound transducer (6-15 MHz) is placed in a sagittal oblique plane over the fourth and fifth ribs at the mid-axillary line. The following muscles are identified overlying the fourth/ fifth rib: the latissimus dorsi (superficial) and serratus anterior muscle (deep) overlying the ribs.

Study Timeline

• Study Start: 2019-07-07
• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Status Verified: 2020-02
• Primary Completion: 2020-02-02
• Study Completion: 2020-02-26
• Last Update Submitted: 2020-02-29
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• ASA I-III patients age 18 to 75 years undergoing unilateral breast surgery

Exclusion Criteria

• Patients refusal
• History of amide local anesthetics allergy
• Alcohol or drug abuse
• Chronic opioid intake
• Language barriers
• Patient with psychiatric disorders
• Contraindications for regional anesthesia
• BMI > 40 Kg/m2
• Obstructive sleep apnea that preclude PCA opioids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAPB group	Deep serratus anterior plane block	Deep Serratus anterior plane block group
ESPB GROUP	Erector spina plain block for mastectomy analgesia	Erector spina plane block group

Primary Outcome Measures

Name	Time	Method
Post-operative pain intensity	pain at 24 hours post operative	pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Cumulative Opioid consumption in the first 24 hours.	24 hours post-operative	Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

Secondary Outcome Measures

Name	Time	Method
Time to patient mobilization	First 24 hours post operative( 0 time is considered time to admission to post anesthesia care unit)	Recording first time patient is able to mobilize without assistance

Trial Locations

Locations (1)

King Saud University; 🇸🇦 Riyadh, Saudi Arabia