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

Pain, Postoperative Clinical Trial

Official title:

Analgesic Efficiency of Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341234
• Other study ID #: Superficial SPB
• Status: Completed
• Phase: N/A
• First received: November 9, 2017
• Last updated: November 9, 2017
• Start date: November 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: November 2017
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Consumption
• Pain, Postoperative
• Postoperative Analgesia

Intervention

Drug:
• Bupivacaine
30 ml %0,25 bupivacaine
• Saline
2 ml saline subcutaneously

Device:
• Ultrasound
Ultrasound guided block

Locations

Country	Name	City	State
Turkey	Regional Training and Research Hospital	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ahiskalioglu A, Alici HA, Yayik AM, Celik M, Oral Ahiskalioglu E. Ultrasound guided serratus plane block for management of acute thoracic herpes zoster. Anaesth Crit Care Pain Med. 2017 Oct;36(5):323-324. doi: 10.1016/j.accpm.2017.01.008. Epub 2017 Mar 21. — View Citation

Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	First 24 hours total fentanyl consumption with patient controlled analgesia	First 24 hours total opioid consumption
Secondary	Visual analog pain score	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 first hour postoperatively.	postoperative first hour
Secondary	Visual analog pain score	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 second hour postoperatively.	postoperative second hour
Secondary	Visual analog pain score	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 4th hour postoperatively.	postoperative 4th hour
Secondary	Visual analog pain score	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 8th hour postoperatively.	postoperative 8th hour
Secondary	Visual analog pain score	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 12th hour postoperatively.	postoperative 12th hour
Secondary	Visual analog pain score	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.	postoperative 24th hour