Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection

Not Applicable

Completed

• Conditions: Pain, Postoperative; Opioid Consumption; Postoperative Analgesia
• Interventions: Drug: Saline; Drug: Bupivacaine; Device: Ultrasound

• Registration Number: NCT03341234
• Lead Sponsor: Ataturk University

Brief Summary

Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade.

The aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-08-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-09
• Last Update Submitted: 2017-11-09
• Study First Posted: 2017-11-14
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection

Exclusion Criteria

• chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group SPB	Ultrasound	Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine
Group Control	Saline	Ultrasound guided sham block with 2 ml saline subcutaneously
Group Control	Ultrasound	Ultrasound guided sham block with 2 ml saline subcutaneously
Group SPB	Bupivacaine	Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine

Primary Outcome Measures

Name	Time	Method
Opioid Consumption	First 24 hours total opioid consumption	First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

Name	Time	Method
Visual analog pain score	postoperative 24th hour	Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.

Trial Locations

Locations (1)

Regional Training and Research Hospital; 🇹🇷 Erzurum, Turkey