NCT02719795

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2016

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 17, 2017

Status Verified

April 1, 2016

Enrollment Period

2.7 years

First QC Date

March 15, 2016

Last Update Submit

February 15, 2017

Conditions

Breast Neoplasms

Keywords

Breast NeoplasmsNerve blockAnesthesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months after modified radical mastectomy surgery

Secondary Outcomes (6)

  • Postoperative Numerical Rating scale (NRS) score for pain

    0 hour postoperative

  • Postoperative Numerical Rating scale (NRS) score for pain

    4 hours postoperative

  • Postoperative Numerical Rating scale (NRS) score for pain

    12 hours postoperative

  • Postoperative Numerical Rating scale (NRS) score for pain

    24 hours postoperative

  • Postoperative Numerical Rating scale (NRS) score for pain

    48 hours postoperative

  • +1 more secondary outcomes

Study Arms (2)

Ropivacaine

EXPERIMENTAL

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

Drug: Ropivacaine

Normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

RopivacaineDRUG

Local injection of local anesthetic into the fascial spaces

Also known as: Naropin
Ropivacaine
Normal salineDRUG

Sodium chloride solution commonly used in clinical which equal to human plasma osmotic pressure.

Also known as: Stroke-physiological saline solution
Normal saline

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hosipital of Xi'an Jiaotong Univercity

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (14)

  • Amaya F, Hosokawa T, Okamoto A, Matsuda M, Yamaguchi Y, Yamakita S, Taguchi T, Sawa T. Can acute pain treatment reduce postsurgical comorbidity after breast cancer surgery? A literature review. Biomed Res Int. 2015;2015:641508. doi: 10.1155/2015/641508. Epub 2015 Oct 1.

    PMID: 26495309BACKGROUND

  • Oeffinger KC, Fontham ET, Etzioni R, Herzig A, Michaelson JS, Shih YC, Walter LC, Church TR, Flowers CR, LaMonte SJ, Wolf AM, DeSantis C, Lortet-Tieulent J, Andrews K, Manassaram-Baptiste D, Saslow D, Smith RA, Brawley OW, Wender R; American Cancer Society. Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update From the American Cancer Society. JAMA. 2015 Oct 20;314(15):1599-614. doi: 10.1001/jama.2015.12783.

    PMID: 26501536RESULT

  • Bolin ED, Harvey NR, Wilson SH. Regional anesthesia for breast surgery: Techniques and benefits. Current Anesthesiology Reports 2015;5:217-224.

    RESULT

  • Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

    PMID: 25376971RESULT

  • Poleshuck EL, Katz J, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for chronic pain following breast cancer surgery: a prospective study. J Pain. 2006 Sep;7(9):626-34. doi: 10.1016/j.jpain.2006.02.007.

    PMID: 16942948RESULT

  • Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

    PMID: 19903919RESULT

  • Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.

    PMID: 12855309RESULT

  • Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.

    PMID: 21831090RESULT

  • Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

    PMID: 22939099RESULT

  • Perez MF, Miguel JG, de la Torre PA. A new approach to pectoralis block. Anaesthesia. 2013 Apr;68(4):430. doi: 10.1111/anae.12186. No abstract available.

    PMID: 23488849RESULT

  • Perez MF, Duany O, de la Torre PA. Redefining PECS Blocks for Postmastectomy Analgesia. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):729-30. doi: 10.1097/AAP.0000000000000243. No abstract available.

    PMID: 26488081RESULT

  • Ibarra MM, S-Carralero GC, Vicente GU, Cuartero del Pozo A, Lopez Rincon R, Fajardo del Castillo MJ. [Chronic postoperative pain after general anesthesia with or without a single-dose preincisional paravertebral nerve block in radical breast cancer surgery]. Rev Esp Anestesiol Reanim. 2011 May;58(5):290-4. doi: 10.1016/s0034-9356(11)70064-0. Spanish.

    PMID: 21692253RESULT

  • Karmakar MK, Samy W, Li JW, Lee A, Chan WC, Chen PP, Ho AM. Thoracic paravertebral block and its effects on chronic pain and health-related quality of life after modified radical mastectomy. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):289-98. doi: 10.1097/AAP.0000000000000113.

    PMID: 24956453RESULT

  • Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534.

    PMID: 18682712RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RopivacaineSaline Solution

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Tan Jing, M.D；PhD

CONTACT

0086-1830298289018991232757@189.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 25, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

February 17, 2017

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

Locations

CN(1)