Post-discharge Pain After Breast-surgery Treated by Paravertebral Block

NCT03618459 | Completed

• 1 other identifier: CERU-1802
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

Breast surgery is known being associated to a high risk of persistent post-operative pain, which has been related, among other factors, to a poorly treated acute pain. Paravertebral block has been successfully employed for anesthesia and analgesia after breast surgery, however its impact on persistent post-operative pain has rarely been investigated. Aim of this study is to assess prevalence, characteristics and consequences of post-discharge pain and its correlation to the incidence of persistent post-operative pain development in a continuous cohort of patients undergoing breast surgery with a paravertebral block. Investigators designed a prospective, observational study on a continuous cohort of adult patients undergoing breast surgery with a standardized thoracic paravertebral block performed before general anesthesia induction. Patients were subsequently interviewed 6 months after hospital discharge in order to assess the incidence, features and duration of post-discharge pain.

Conditions

Mastectomy, Segmental; Regional Anesthesia

Keywords

Breast surgery; Paravertebral block; Pain Control

Outcome Measures

Primary Outcomes (1)

• Post-discharge pain

  Primary endpoint of this study is to assess the incidence of post-discharge pain in a cohort of patients undergoing breast surgery with a single shot thoracic paravertebral block.

  6 months post-surgery

Secondary Outcomes (2)

• Pain characteristics

  6 months post-surgery

• Pain impact

  6 months post-surgery

Study Arms (1)

Breast-surgery patients

A consecutive cohort of adult patients undergoing breast surgery with a combined anesthesia technique, employing a thoracic single-shot paravertebral block performed before surgery. Operations performed were in all cases unilateral tumor resections, lumpectomies and mastectomies without axillary lymphadenectomy.

Other: Phone questionnaire

Interventions

Phone questionnaire OTHER

Patients were contacted by phone 6 months after surgery and, after oral consent, a standardized questionnaire was administered in order to inquiry about the length and nature of post-operative pain, the incidence of post-discharge pain, its characteristics, its impact on daily life, its treatment and its rate of chronicity

Breast-surgery patients

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

A consecutive cohort of adult patients undergoing breast surgery with a combined anesthesia technique, employing a thoracic single-shot paravertebral block performed before surgery. Operations performed were in all cases unilateral tumor resections, lumpectomies and mastectomies without axillary lymphadenectomy.

You may qualify if:

• female sex
• years or greater
• elective breast surgery (tumor resection, mastectomy, lumpectomy)
• local regional anesthesia

You may not qualify if:

• patients refusal,
• general contraindications to regional anesthesia,
• the inability to perform a complete block
• diagnosed COPD or other respiratory diseases,
• ASA score risk greater than 3.

Sponsors & Collaborators

• Samuele Ceruti: lead
• Ente Ospedaliero Cantonale, Bellinzona: collaborator

Study Sites (1)

Andrea Saporito MD

Bellinzona, 6500, Switzerland

Location

Related Publications (11)

• 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: 17406360 RESULT

• 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: 21435953 RESULT

• 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: 15655557 RESULT

• Peuckmann V, Ekholm O, Rasmussen NK, Groenvold M, Christiansen P, Moller S, Eriksen J, Sjogren P. Chronic pain and other sequelae in long-term breast cancer survivors: nationwide survey in Denmark. Eur J Pain. 2009 May;13(5):478-85. doi: 10.1016/j.ejpain.2008.05.015. Epub 2008 Jul 16.

  PMID: 18635381 RESULT

• Blyth FM, March LM, Brnabic AJ, Cousins MJ. Chronic pain and frequent use of health care. Pain. 2004 Sep;111(1-2):51-8. doi: 10.1016/j.pain.2004.05.020.

  PMID: 15327808 RESULT

• Blyth FM, March LM, Cousins MJ. Chronic pain-related disability and use of analgesia and health services in a Sydney community. Med J Aust. 2003 Jul 21;179(2):84-7. doi: 10.5694/j.1326-5377.2003.tb05441.x.

  PMID: 12864718 RESULT

• Andreae MH, Andreae DA. Local anaesthetics and regional anaesthesia for preventing chronic pain after surgery. Cochrane Database Syst Rev. 2012 Oct 17;10:CD007105. doi: 10.1002/14651858.CD007105.pub2.

  PMID: 23076930 RESULT

• 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: 23290256 RESULT

• Staud R. Peripheral pain mechanisms in chronic widespread pain. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):155-64. doi: 10.1016/j.berh.2010.01.010.

  PMID: 22094192 RESULT

• Mejdahl MK, Andersen KG, Gartner R, Kroman N, Kehlet H. Persistent pain and sensory disturbances after treatment for breast cancer: six year nationwide follow-up study. BMJ. 2013 Apr 11;346:f1865. doi: 10.1136/bmj.f1865.

  PMID: 23580693 RESULT

• Saporito A, Aguirre J, Borgeat A, Perren A, Anselmi L, Poggi R, Minotti B, Cafarotti S, La Regina D, Ceruti S. Persistent postdischarge pain and chronic postoperative pain after breast cancer surgery under general anesthesia and single-shot paravertebral block: incidence, characteristics and impact on quality of life and healthcare costs. J Pain Res. 2019 Apr 16;12:1193-1199. doi: 10.2147/JPR.S195702. eCollection 2019.

  PMID: 31114301 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciano Anselmi, MD

  Ente Ospedaliero Cantonale, Bellinzona

  STUDY CHAIR

• Andrea Saporito, MD

  Ente Ospedaliero Cantonale, Bellinzona

  PRINCIPAL INVESTIGATOR

• José Aguirre, MD

  Balgrist

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 7, 2018
• Study Start: January 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)