NCT03448913

Brief Summary

This observational study evaluates difference in chronic pain after six months from surgery between patients who received PECS block and general anesthesia versus general anesthesia alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

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

Study Start

First participant enrolled

February 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

February 19, 2018

Last Update Submit

March 10, 2019

Conditions

Chronic Pain Post-Procedural

Keywords

Anesthesia, Regional ;PECS block

Outcome Measures

Primary Outcomes (1)

  • Chronic pain at six months

    Presence of chronic pain at six months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain

    six months

Secondary Outcomes (5)

  • Chronic pain at three months

    three months

  • Chronic pain at nine months

    nine months

  • Chronic pain at twelve months

    twelve months

  • Difference in opioid consumption during surgery

    day of surgery

  • Difference in pain in the first 24 hours after surgery

    first 24 hours after surgery

Study Arms (2)

PECS block+ General anesthesia

Patients undergoing mastectomy, partial mastectomy and/or axillary clearance who received PECS block AND general anesthesia for the surgery.

Procedure: PECS block

General anesthesia

Patients undergoing mastectomy, partial mastectomy and/or axillary clearance who received general anesthesia only for the surgery.

Interventions

PECS blockPROCEDURE

It consists in injection of 20-30 ml of local anesthetic between pectoral minor, pectoral major, and serratus muscles.

PECS block+ General anesthesia

Eligibility Criteria

Age18 Years - 86 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients needing breast surgery (mastectomy, partial mastectomy and/or axillary clearence)

You may qualify if:

  • programmed breast surgery
  • informed consent

You may not qualify if:

  • bilateral breast surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padova

Padua, 35127, Italy

Location

Related Publications (5)

  • Cronin-Fenton DP, Norgaard M, Jacobsen J, Garne JP, Ewertz M, Lash TL, Sorensen HT. Comorbidity and survival of Danish breast cancer patients from 1995 to 2005. Br J Cancer. 2007 May 7;96(9):1462-8. doi: 10.1038/sj.bjc.6603717. Epub 2007 Apr 3.

    PMID: 17406360BACKGROUND

  • Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.

    PMID: 21435953BACKGROUND

  • Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. doi: 10.1038/sj.bjc.6602304.

    PMID: 15655557BACKGROUND

  • 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: 21831090BACKGROUND

  • Wijayasinghe N, Andersen KG, Kehlet H. Analgesic and Sensory Effects of the Pecs Local Anesthetic Block in Patients with Persistent Pain after Breast Cancer Surgery: A Pilot Study. Pain Pract. 2017 Feb;17(2):185-191. doi: 10.1111/papr.12423. Epub 2016 Feb 9.

    PMID: 26857336RESULT

Study Officials

  • Alessandro De Cassai, MD

    University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 28, 2018

Study Start

February 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

IT(1)