Serratus Plane Block in Preventing Postoperative Pain of Mastectomy

NCT ID: NCT03615430

Last Updated: 2020-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Serratus Plane Block Chronic Pain Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

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

Group Type PLACEBO_COMPARATOR

serratus plane block with saline

Intervention Type 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.

SPB group

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

Group Type EXPERIMENTAL

serratus plane block with local anesthetic

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Feng Xia

OTHER

Sponsor Role lead

Responsible Party

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Feng Xia

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xia Feng, MD.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 29227351 (View on PubMed)

Other Identifiers

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[2016]124

Identifier Type: -

Identifier Source: org_study_id

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