Chronic Pain and Minor Breast Cancer Surgery

NCT ID: NCT03912948

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 205 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-12-31

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.

Detailed Description

This is a prospective observational study assessing the interest of preoperative thoracic block (injection of local anesthetic around the serratus muscle under ultrasound guidance) in the prevalence of chronic pain 3 months after a conservative breast cancer surgery.

Information on the present survey was given during pre-operative consultation and signed informed consent was obtained to enter the study.

The management of patients undergoing minor surgery for breast cancer is standardized within our department and reported in our previous study. After starting the induction of anesthesia and insertion of a laryngeal mask, a regional analgesia technique was performed under ultrasonography. Twenty ml of ropivacaine 3.75mg/ml were injected under the serratus muscle, at the lateral edge of the minor pectoralis muscle. In the absence of contraindications, multimodal analgesia consisted of paracetamol, non-steroidal anti-inflammatory drugs and nefopam. Postoperative intravenous morphine titration was possible in patients presenting a pain score >3/10 (numeric pain intensity scale from 0 = no pain to 10 = maximum imaginable pain) in the recovery room. If 0.1mg/kg of morphine did not permit to alleviate pain, ketamine titration was initiated by the anesthesiologist.

The incidence of patients that required opioids titration in the recovery room (and the dose injected) was recorded.

The questionnaire sent to the patients 3 months after their surgery was mainly composed of closed questions. This questionnaire included pain score, location of pain, analgesic drugs consumption, neuropathic component (self-administered questionnaire derived from the Neuropathic Pain 4 Questions - DN4 questionnaire), impact of quality of life using the Brief Pain Inventory.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Claudius Regaud - IUCT-Oncopole

Toulouse, Occitanie, France

Countries

France

References

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.

Reference Type: RESULT

PMID: 19903919 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27885426 (View on PubMed)

Study Documents

Document Type: Web site for patient information on studies bases on patients data (RGPD)

View Document

Other Identifiers

CNIL-2033408

Identifier Type: -

Identifier Source: org_study_id