NCT03782896

Brief Summary

Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to study risk factors. A study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain. This study try to find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

December 31, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 31, 2020

Status Verified

December 1, 2018

Enrollment Period

11 months

First QC Date

December 19, 2018

Last Update Submit

January 30, 2020

Conditions

Breast CancerChronic Post-Procedural Pain

Outcome Measures

Primary Outcomes (2)

  • persistent pain

    persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)

    postoperative 2 months

  • acute postoperative pain

    acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)

    postoperative 1 hour

Secondary Outcomes (9)

  • inhalation agent

    intraoperative

  • opioid consumption

    intraoperative

  • surgical anxiety level

    1 day before surgery

  • anticipate pain

    1 day before surgery

  • anticipated pain medication need

    1 day before surgery

  • +4 more secondary outcomes

Study Arms (1)

mastectomy group

All patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)

Other: acute postoperative pain

Interventions

acute postoperative painOTHER

All patients assessed postoperative pain score in the recovery room and postoperative 2 month

mastectomy group

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the 20-70 year old patients who undergoing breast conserving surgery + sentinel lymph node dissection at samsung medical center

You may qualify if:

  • undergoing breast conserving surgery + sentinel lymph node dissection

You may not qualify if:

  • cardiac arrythmia
  • allergic history for drugs
  • renal failure (Cr\> 1.5 mg/dl)
  • performing axillary lymph node dissection or Total mastectomy
  • difficult airway and failed to place laryngeal mask airway properly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

Related Publications (5)

  • Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.

    PMID: 23290256BACKGROUND

  • Cui L, Fan P, Qiu C, Hong Y. Single institution analysis of incidence and risk factors for post-mastectomy pain syndrome. Sci Rep. 2018 Jul 31;8(1):11494. doi: 10.1038/s41598-018-29946-x.

    PMID: 30065342BACKGROUND

  • 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: 19903919BACKGROUND

  • Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.

    PMID: 23485992BACKGROUND

  • Lefebvre-Kuntz D, Duale C, Albi-Feldzer A, Nougarede B, Falewee MN, Ouchchane L, Soule-Sonneville S, Bonneau J, Dubray C, Schoeffler P. General anaesthetic agents do not influence persistent pain after breast cancer surgery: A prospective nationwide cohort study. Eur J Anaesthesiol. 2015 Oct;32(10):697-704. doi: 10.1097/EJA.0000000000000215.

    PMID: 26053994BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 20, 2018

Study Start

December 31, 2018

Primary Completion

December 5, 2019

Study Completion

December 30, 2019

Last Updated

January 31, 2020

Record last verified: 2018-12

Locations

KR(1)