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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04296188
• Other study ID #: 19KAEK253
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 18, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2020
• Source: Tokat Gaziosmanpasa University
• Contact: mehtap gürler balta, MD
• Phone: +903562129500
• Email: drmehtapgurler[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 15, 2021
• Est. primary completion date: February 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mastectomy
• Pain, Postoperative
• Recovery Period, Anesthesia

Intervention

Procedure:
• serratus anterior plane block
ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.
• erector spina plane block
ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic consumption	Tramadol dose will be calculated as milligram	From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours
Secondary	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
Secondary	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
Secondary	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