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

• Sponsor: Ataturk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03341234
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Analgesia; Pain, Postoperative; Opioid Consumption	Drug: Bupivacaine; Drug: Saline; Device: Ultrasound	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Analgesic Efficiency of Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection: Randomized Controlled Study
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group SPB Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine	Drug: Bupivacaine; 30 ml %0,25 bupivacaine; Device: Ultrasound; Ultrasound guided block
Active Comparator: Group Control Ultrasound guided sham block with 2 ml saline subcutaneously	Drug: Saline; 2 ml saline subcutaneously; Device: Ultrasound; Ultrasound guided block

Outcome Measures

Primary Outcome Measures

1. Opioid Consumption [First 24 hours total opioid consumption]

   First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

1. Visual analog pain score [postoperative first 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 first hour postoperatively.

2. Visual analog pain score [postoperative second 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 second hour postoperatively.

3. Visual analog pain score [postoperative 4th 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 4th hour postoperatively.

4. Visual analog pain score [postoperative 8th 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 8th hour postoperatively.

5. Visual analog pain score [postoperative 12th 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 12th hour postoperatively.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional Training and Research Hospital	Erzurum		Turkey	25070

Sponsors and Collaborators

• Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Ahmet Murat Yayik, Principal Investigator, Ataturk University
• ClinicalTrials.gov Identifier: NCT03341234
• Other Study ID Numbers: Superficial SPB
• First Posted: Nov 14, 2017
• Last Update Posted: Nov 14, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Ahmet Murat Yayik, Principal Investigator, Ataturk University: Superficial Serratus Plane Block; Modified Radical Mastectomy; Axillary Lymph Node Disection; bupivacaine
• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine

Study Results

No Results Posted as of Nov 14, 2017