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

Comparison of Erector Spina Plane Block and Serratus Anterior Plane Block in Patients Undergoing Mastectomy

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Recovery Period, Anesthesia; Mastectomy
• Intervention / Treatment: Procedure: serratus anterior plane block; Procedure: erector spina plane block

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: serratus anterior plane block; ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.
Active Comparator: 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.	Procedure: erector spina plane block; ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity	Numeric rating scale which is 0 to 10 will be recorded.In this scale, 0 is no pain, 10 is the worst pain.	At 0,2,4,6,12,24th hours after surgery
Quality of recovery	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)	At postoperative 24th hours
The number of patients with perioperative side effects	The number of patients with perioperative side effects(emesis, nausea, local anesthetic toxicity, pneumothorax, local hematoma) will be recorded	From 30 minute before surgery to postoperative 24th hours

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 18, 2020
• Primary Completion (Anticipated): February 27, 2021
• Study Completion (Anticipated): March 15, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Pain Management; Quality of Healthcare
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 19KAEK253

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No