Serratus Plane Block in Preventing Postoperative Pain of Mastectomy

NCT03615430 | Completed

• 1 other identifier: [2016]124
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Serratus Plane Block; Chronic Pain; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the change trend of Numerical Rating Scale (NRS) after surgery

  0-24 hours after operation

• Morphine consumption

  0-24 hours after operation

Study Arms (2)

Control group

PLACEBO COMPARATOR

saline control group, 15 mL of the saline was administered to superficial and deep surface of serratus anterior in Control group via ultrasound before the surgery

Procedure: serratus plane block with saline

SPB group

EXPERIMENTAL

Serratus plane block group, 15ml of 0.25% ropivacaine, a widely used local anesthetic for peripheral nerve block, was administered to superficial and deep surface of serratus anterior in SPB group via ultrasound before the surgery

Procedure: serratus plane block with local anesthetic

Interventions

serratus plane block with local anesthetic PROCEDURE

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.

SPB group

serratus plane block with saline PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: subject undergoing radical mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Feng Xia: lead

Study Sites (1)

Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

Related 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.

  PMID: 29227351 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Breast Neoplasms

Interventions

Anesthetics, Local; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Xia Feng, MD.

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 3, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)