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NCT Number: NCT03615430

Serratus Plane Block in Preventing Postoperative Pain of Mastectomy

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.

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Key information

Conditions

Serratus Plane Block Breast Cancer Breast Diseases Breast Neoplasms Chronic Pain Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Numerical Rating Scale (NRS) of chronic pain

    Time frame: 3 months 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 effect of SPB in preventing chronic pain

Secondary outcomes

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

    Time frame: 0-24 hours after operation

    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

  2. Morphine consumption

    Time frame: 0-24 hours after operation

    extra need of analgesic

Sponsors and collaborators

Lead sponsor

Feng Xia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2018
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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