Pectoral Nerves Blocks for Chronic Pain (PNBCP)

February 15, 2017 updated by: First Affiliated Hospital Xi'an Jiaotong University

Pectoral Nerves Blocks and Their Effect on Chronic Pain After Breast Cancer Surgery

The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduce chronic pain at 3 months after modified radical mastectomy（MRM）surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

One hundred and forty adult female participants scheduled for elective unilateral modified radical mastectomy under general anesthesia are randomly allocated to receive either general anesthesia plus Pecs block(Pecs group, n=70) or general anesthesia alone (control group, n=70).

After arrived in the operating room，the participants in the control group are accepted the general anesthesia.Whereas，after anesthesia induction，the participants in the Pecs group receive an ultrasound-guided Pecs block and a 15 minute observation time prior before the start of the operation.

Pecs block technology： A broadband (5-12 hertz) linear array probe of Sonosite Edge portable ultrasound system (Sonosite Inc,Bethel,Washington) is used, with an imaging depth of 4 to 6 cm. After cleaning the infraclavicular and axillary regions with chlorhexidine, the probe is placed below the lateral third of the clavicle, similar to what is done when performing infraclavicular brachial plexus block. After recognition of the appropriate anatomical structures, the skin puncture point is infiltrated with 2% lignocaine, then the block is performed by using a 20-gauge Tuohy needle. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.35% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib below the serratus anterior muscle with the intent of spreading injectate to the axilla.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hosipital of Xi'an Jiaotong Univercity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Modified radical mastectomy
  • American Society of Anesthesiologists physical status 1-3
  • BMI 18-35 kg/m2

Exclusion Criteria:

  • Declining to give written informed consent；
  • Uncontrolled hypertension；
  • Allergy to local anesthetics；
  • Pregnancy；
  • Alcohol or drug abuse；
  • Prior breast surgery except for diagnostic biopsies；
  • Contraindication to the use of regional anesthesia；
  • History of chronic pain or psychiatric disorder and pregnant patients；
  • Consumption of NSAID, cyclooxygenase-2 inhibitors or paracetamol within 24 hours before the investigation；
  • Infection at the needle site.
  • Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine
Ropivacaine hydrochloride injection； Generic name：Naropin； Dosage form：Liquid、Injectable formulation； Dosage：105mg；30ml； Frequency：Once.
Drug: Ropivacaine
Local injection of local anesthetic into the fascial spaces
Other Names:
  • Naropin
Placebo Comparator: Normal saline
Medical Normal saline Generic name：Normal saline； Dosage form：Liquid、Injectable formulation； Dosage：30ml； Frequency：Once.
Drug: Normal saline
Sodium chloride solution commonly used in clinical which equal to human plasma osmotic pressure.
Other Names:
  • Stroke-physiological saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of chronic postoperative pain for 3 months after modified radical mastectomy surgery
Time Frame: 3 months after modified radical mastectomy surgery
An anesthesiologist interviews the patients by phone to determine the postoperative pain at 3 months after surgery. Chronic pain is defined as pain in the surgical area or the ipsilateral arm, present at least 4 days a week, with an intensity of 3 or more on the verbal rating scale（0=no pain to 10=worst imaginable pain),described as a typical neuropathic pain consisting of burning pain, shooting pain, pain evoked by pressure, and deep blunt pain.
3 months after modified radical mastectomy surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Numerical Rating scale (NRS) score for pain
Time Frame: 0 hour postoperative
Pain scores（0-10）during rest and cough based on measurement at 0 hour postoperative.
0 hour postoperative
Postoperative Numerical Rating scale (NRS) score for pain
Time Frame: 4 hours postoperative
Pain scores（0-10）during rest and cough based on measurement at 4 hours postoperative.
4 hours postoperative
Postoperative Numerical Rating scale (NRS) score for pain
Time Frame: 12 hours postoperative
Pain scores（0-10）during rest and cough based on measurement at 12 hours postoperative.
12 hours postoperative
Postoperative Numerical Rating scale (NRS) score for pain
Time Frame: 24 hours postoperative
Pain scores（0-10）during rest and cough based on measurement at 24 hours postoperative.
24 hours postoperative
Postoperative Numerical Rating scale (NRS) score for pain
Time Frame: 48 hours postoperative
Pain scores（0-10）during rest and cough based on measurement at 48 hours postoperative.
48 hours postoperative
Postoperative Numerical Rating scale (NRS) score for pain
Time Frame: 72 hours postoperative
Pain scores（0-10）during rest and cough based on measurement at 72 hours postoperative.
72 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRS-2016-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on Ropivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe