Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain

Not Applicable

• Conditions: Pain, Postoperative; Mastectomy; Recovery Period, Anesthesia
• Interventions: Procedure: erector spina plane block; Procedure: serratus anterior plane block

• Registration Number: NCT04296188
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.

Detailed Description

Mastectomy may cause severe postoperative pain. There are several analgesic methods for postoperative pain management. Serratus anterior plane (SAP) block is an interfascial plane block which is performed into the fascial plane of serratus anterior muscle. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. There are several studies about its analgesic efficacy for mastectomy pain. The erector spina plane (ESP) block is another novel plan block which provides analgesia at multi-dermatomal area of the anterior, posterior, and lateral thoracic and abdominal walls. There are some studies about its effectiveness for postoperative mastectomy pain management. However, according to our best knowledge, there is no literature comparing the efficacy of ESP block and SAP block patients undergoing mastectomy.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-05
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12
• Study Start: 2020-03-18
• Primary Completion: 2021-02-27
• Study Completion: 2021-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• American society of score anesthesiologist I-II-III
• Elective modified radical mastectomy
• 18-65 years old

Exclusion Criteria

• neurological disease
• coagulopathy disease or using anticoagulants
• non-cooperative
• allergic to one of the drugs used in the study
• recurrent breast cancer
• body mass index is above 35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erector spina plane block	erector spina plane block	The erector spina plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via PCA device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.
serratus anterior plane block	serratus anterior plane block	The serratus anterior plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via patient controlled analgesia (PCA) device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.

Primary Outcome Measures

Name	Time	Method
Analgesic consumption	From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours	Tramadol dose will be calculated as milligram

Secondary Outcome Measures

Name	Time	Method
Quality of recovery	At postoperative 24th hours	Quality of recovery (QoR-40) questionaire will be recorded. The QoR-40 is a questionaire which measures of five dimensions of health: patient support, comfort, emotions, physical independence, and pain on a five-point likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
Postoperative pain intensity	At 0,2,4,6,12,24th hours after surgery	Numeric rating scale which is 0 to 10 will be recorded.In this scale, 0 is no pain, 10 is the worst pain.
The number of patients with perioperative side effects	From 30 minute before surgery to postoperative 24th hours	The number of patients with perioperative side effects(emesis, nausea, local anesthetic toxicity, pneumothorax, local hematoma) will be recorded