Chronic Pain and Minor Breast Cancer Surgery

NCT03912948 | Completed

• 1 other identifier: CNIL-2033408
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most frequent in women. Early diagnosis and recent treatments have improved overall mortality. However, chronic pain (pain lasting more than 3 months after surgery) remains a public health problem with impact on quality of life for these patients. The incidence of pain has been reported up to 25 to 60% of patients in the literature, even many years after a radical mastectomy. The neuropathic component of the pain is usually underestimated. In a prospective cohort study we have demonstrated that 43% of patient needed on average 5mg of morphine intravenously in the recovery room after a conservative breast cancer surgery, despite a multimodal regimen of analgesic drugs. In the same study, 40% of patients reported persistent pain 3 months after the surgery. To improve the analgesia in such a population, we decided to introduce regional analgesia technique (serratus block) systematically. This became our gold standard in our daily practice. We would like to assess the efficacy of such regional analgesia techniques on opioids consumption in the recovery room and the incidence of pain 3 months after conservative breast cancer surgery.

Conditions

Surgery; Breast Cancer; Pain, Postoperative; Pain, Chronic

Keywords

regional analgesia techniques; breast cancer surgery; conservative surgery

Outcome Measures

Primary Outcomes (1)

• Prevalence of chronic pain

  To assess the number (%) of patients presenting persistent pain 3 months after minor breast cancer surgery

  3 months

Secondary Outcomes (1)

• Incidence of pain

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women \>18yrs old, with ASA physical status 1 to 3, with unilateral breast adenocarcinoma treated surgically by conservative tumorectomy ± associated to sentinel lymph node dissection on an ambulatory basis.

You may qualify if:

• women
• \> 18 years old
• with "American Society of Anesthesiologists-ASA" physical status 1 to 3
• with unilateral breast cancer adenocarcinoma treated surgically by conservative tumorectomy associated or not to sentinel lymph node dissection on an ambulatory basis

You may not qualify if:

• None

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Claudius Regaud - IUCT-Oncopole

Toulouse, Occitanie, 31059 cedex 09, France

Location

Related Publications (2)

• 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: 19903919 RESULT

• Fuzier R, Puel F, Izard P, Sommet A, Pierre S. Prospective cohort study assessing chronic pain in patients following minor surgery for breast cancer. J Anesth. 2017 Apr;31(2):246-254. doi: 10.1007/s00540-016-2288-9. Epub 2016 Nov 24.

  PMID: 27885426 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Chronic Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: March 4, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)