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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02838173
Other study ID # B406201628750
Secondary ID
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


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
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