Serratus Plane Block in Preventing Postoperative Pain of Mastectomy

Breast Cancer Clinical Trial

Official title:

The Effect of Serratus Plane Block in Preventing Postoperative Pain and Chronic Pain After Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615430
• Other study ID #: [2016]124
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2020
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, double-blinded randomized controlled, 1-year follow-up study was designed to compare the analgesic effect of serratus plane block (SPB) after breast cancer surgery. Women undergoing radical mastectomy were dIvided into Control group and SPB group. The postoperative acute pain was evaluated by numerical rating scale (NRS) and the effect of preventing chronic pain was assessed at 3, 6, 12 months after surgery by NRS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• women undergoing radical mastectomy with either sentinel lymph node dissection or axillary lymph node dissection or no axillary lymph node dissection

• between the ages of 18 and 85 yr

• with an American Society of Anesthesiology (ASA) physical status I or II

• without any significant cardiopulmonary, renal and hepatic dysfunction

Exclusion Criteria:

• Patients with any previous cancer other than breast cancer

• occurrence of allergy to local anesthetics

• occurrence of opioid-tolerant subjects

• occurrence of consuming analgesics, sedatives, antidepressants or any history of substance abuse before surgery

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Pain
• Pain, Postoperative
• Serratus Plane Block

Intervention

Procedure:
• serratus plane block with local anesthetic
The high-frequency linear array ultrasound transducer (UST) was placed parallel to the cephalocaudal axis of the body in T4 levels on the side of the mid-axillary line, identifying latissimus dorsi and serratus anterior, through the thoracic artery to help to find the serratus anterior and 15 ml 0.25% ropivacaine was administered.
• serratus plane block with saline
The high-frequency linear array ultrasound transducer (UST) was placed parallel to the cephalocaudal axis of the body in T4 levels on the side of the mid-axillary line, identifying latissimus dorsi and serratus anterior, through the thoracic artery to help to find the serratus anterior and 15 ml saline was administered.

Locations

Country	Name	City	State
China	Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Feng Xia

Country where clinical trial is conducted

China, 

References & Publications (1)

Kamiya Y, Hasegawa M, Yoshida T, Takamatsu M, Koyama Y. Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Mar;35(3):215-223. doi: 10.1097/EJA.0000000000000762. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS) of chronic pain	Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of SPB in preventing chronic pain	3 months after surgery
Secondary	the change trend of Numerical Rating Scale (NRS) after surgery	Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the analgesic effect of SPB	0-24 hours after operation
Secondary	Morphine consumption	extra need of analgesic	0-24 hours after operation