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Pectoral Nerves Blocks for Chronic Pain (PNBCP)

Primary Purpose

Breast Neoplasms

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Ropivacaine
Normal saline
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast Neoplasms, Nerve block, Anesthesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • First Affiliated Hosipital of Xi'an Jiaotong UnivercityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine

Normal saline

Arm Description

Ropivacaine hydrochloride injection; Generic name:Naropin; Dosage form:Liquid、Injectable formulation; Dosage:105mg;30ml; Frequency:Once.

Medical Normal saline Generic name:Normal saline; Dosage form:Liquid、Injectable formulation; Dosage:30ml; Frequency:Once.

Outcomes

Primary Outcome Measures

The incidence of chronic postoperative pain for 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.

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2016
Last Updated
February 15, 2017
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT02719795
Brief Title
Pectoral Nerves Blocks for Chronic Pain
Acronym
PNBCP
Official Title
Pectoral Nerves Blocks and Their Effect on Chronic Pain After Breast Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Breast Neoplasms, Nerve block, Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
Ropivacaine hydrochloride injection; Generic name:Naropin; Dosage form:Liquid、Injectable formulation; Dosage:105mg;30ml; Frequency:Once.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Medical Normal saline Generic name:Normal saline; Dosage form:Liquid、Injectable formulation; Dosage:30ml; Frequency:Once.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Local injection of local anesthetic into the fascial spaces
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Stroke-physiological saline solution
Intervention Description
Sodium chloride solution commonly used in clinical which equal to human plasma osmotic pressure.
Primary Outcome Measure Information:
Title
The incidence of chronic postoperative pain for 3 months after modified radical mastectomy surgery
Description
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.
Time Frame
3 months after modified radical mastectomy surgery
Secondary Outcome Measure Information:
Title
Postoperative Numerical Rating scale (NRS) score for pain
Description
Pain scores(0-10)during rest and cough based on measurement at 0 hour postoperative.
Time Frame
0 hour postoperative
Title
Postoperative Numerical Rating scale (NRS) score for pain
Description
Pain scores(0-10)during rest and cough based on measurement at 4 hours postoperative.
Time Frame
4 hours postoperative
Title
Postoperative Numerical Rating scale (NRS) score for pain
Description
Pain scores(0-10)during rest and cough based on measurement at 12 hours postoperative.
Time Frame
12 hours postoperative
Title
Postoperative Numerical Rating scale (NRS) score for pain
Description
Pain scores(0-10)during rest and cough based on measurement at 24 hours postoperative.
Time Frame
24 hours postoperative
Title
Postoperative Numerical Rating scale (NRS) score for pain
Description
Pain scores(0-10)during rest and cough based on measurement at 48 hours postoperative.
Time Frame
48 hours postoperative
Title
Postoperative Numerical Rating scale (NRS) score for pain
Description
Pain scores(0-10)during rest and cough based on measurement at 72 hours postoperative.
Time Frame
72 hours postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tan Jing, M.D;PhD
Phone
0086-18302982890
Email
18991232757@189.cn
Facility Information:
Facility Name
First Affiliated Hosipital of Xi'an Jiaotong Univercity
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tan Jing, M.D;PhD
Phone
0086-18302982890
Email
18991232757@189.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26495309
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
25376971
Citation
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16942948
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Pectoral Nerves Blocks for Chronic Pain

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