Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery

Chronic Pain Clinical Trial

Official title:

Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02838173
• Other study ID #: B406201628750
• Status: Not yet recruiting
• Phase: N/A
• First received: June 30, 2016
• Last updated: July 19, 2016
• Start date: July 2016
• Est. completion date: March 2018

Study information

• Verified date: June 2016
• Source: Erasme University Hospital
• Contact: Céline Boudart, MD
• Phone: 3225553919
• Email: cboudart[@]ulb.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

This study compare the "Serratus block plane" (SPB) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery.

Description:

Chronic pain after breast surgery may be severe, often requiring the use of morphine. The incidence of chronic pain varies from 27 to 50% depending on definitions.

The infiltration of tissues by a local anesthetic is a simple, fast and low risk technique but of limited effectiveness.

Serratus the flat block, performed under ultrasound guidance, is minimally invasive and easy to perform. It allows anesthesia and analgesia to an extended part of the anterolateral chest wall and the axilla. This regional anesthesia technique provides good analgesia during and after breast surgery, but remains to be evaluated; beyond perioperative analgesia, the benefit-risk, post operative rehabilitation, and the impact on ambulatory and on chronic pain are fundamental objectives.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women scheduled for elective breast neoplasm surgery

• Of ASA classification 1, 2 or 3

• Patients who provide written informed consent

Exclusion Criteria:

• Minor patients

• Patients refusing to sign the consent

• Patients included in another protocol within 3 months

• Pregnant or lactating patients

• Patients with history of allergy to local anesthetics (Ropivacaine)

• Patients with contraindication to regional anesthesia (coagulopathy, local infection ...)

• Patients with history of prior breast surgery (excluding diagnostic biopsy)

• Patients with history of chronic pain

• Patients with a history of psychiatric disorder

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast/Surgery
• Chronic Pain
• Postoperative Complication
• Postoperative Complications

Intervention

Procedure:
• serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)

• tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)

• serratus plane bloc : placebo

• tissue infiltration : placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

References & Publications (2)

Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28. Review. — View Citation

Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of stay in the Postoperative Acute Care Unit		through study completion	No
Other	length of stay in hospital		through study completion	No
Primary	postoperative chronic pain assessed using the DN4 questionnaire	DN4 questionnaire	3 months postoperative	No
Secondary	postoperative acute pain	Visual analogue scale (V.A.S.)	day 1, day 2, day 3 postoperative	No
Secondary	morphine consumption		day 1, day 2, day 3 postoperative	No