Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on Chronic Pain of a Mastectomy

Mastectomy Clinical Trial

— PECS  

Official title:

Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on the Rate of Chronic Pains 6 Month After a Mastectomy Associated or Not With Axillary Node Dissection and/or a Reconstruction Prosthesis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023007
• Other study ID #: PECS-1601
• Secondary ID: N°IdRCB : N°2016
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: August 22, 2019

Study information

• Verified date: November 2022
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.

Description:

The aim of this study is to assess the care given to treat breast cancer while the patient receives a total mastectomy. It is done by evaluating the technique of anesthesia PECS used during this procedure so that the rate of chronic pain can be measured 6 month after the operation.

As well as total mastectomy, patients are also eligible for an axillary lymph node dissection (ALND) and a reconstruction of the breast by prosthesis as options.

Other objectives of the study include:

• Evaluating the effectiveness of the PECS anesthesia technique on the trajectory of acute post-operative pain and on chronic pain after 12 month of the surgery

• Evaluating the type and intensity of the pain

• Evaluating the quality of life

• Study the link between chronic pain and the trajectory of acute pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: August 22, 2019
• Est. primary completion date: February 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with unilateral breast cancer

• Surgery must be a total mastectomy +/- axillary lymph node dissection and +/- reconstruction by prosthesis; unless first surgery was performed more than 5 years prior to total mastectomy without any residual pain

• Age = 18 ans

• Non-opposition of patients

Exclusion Criteria:

• Reconstruction by other than prosthesis

• Previous breast surgery in the last year

• Hypersensitivity or allergy of anaesthetics

• Coagulopathy and local infections

• Pregnant or breastfeeding

• Patients under guardianship

Related Conditions & MeSH terms

• Breast Neoplasms
• Breastcancer
• Chronic Pain
• Mastectomy

Intervention

Procedure:
• Loco-regional anaesthesia
Loco-regional anaesthesia

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prediction of the post-operative chronic pain with Kalkman score	The Kalkman score is a validated risk scale based on patient's history and the type of surgery	within the 15 days before the surgery
Primary	Rate of chronic pain	The rate of chronic pain will be assessed in percentage (%) based on the criteria of the International Association for the Study Pain (IASP) during an algology medical consultation.	6 month after surgery
Secondary	Acute post-operative pain	A representation of the trajectory of pain in the 3 days will be drawn. This pain trajectory is defined as the kinetics of the average daily visual analog scale (VAS) score for 3 days.	During the 3 days following the surgery
Secondary	Side effects post-operative	All side effects (e.g. nausea, vomiting etc.) will be recorded, with its date, time, severity, relation with the treatment, treatment associated and evolution. The intensity of adverse events will be scored using the criteria from NCI-CTCAE version 4.0.	During the 3 days following the surgery
Secondary	Rate of chronic pain	Assessed based on the criteria of the International Association for the Study Pain (IASP) collected via telephone call.	12 month after the surgery
Secondary	Type of chronic pain	The type of chronic pain will be determined using the DN4 score. The DN4 score is a form used for the diagnostic of neuropathic pain.	6 and 12 month after surgery
Secondary	Intensity of chronic pain	The intensity of the pain will be recorded using the visual analog scale (VAS).	6 and 12 month after surgery
Secondary	predictive factors of survival	Using the proportional hazards model.	an average of 1 year
Secondary	Quality of life of the patient assessed with the QLQ-C30 questionnaire	QLQ-C30 from the EORTC (quality of life in general, physical condition, limitations to activities, cognitive functions, emotional and social and symptoms occurrences related to cancer or the treatment)	an average of 1 year
Secondary	Quality of life of the patient assessed with the QLQ-BR23 questionnaire	QLQ-BR23 (body image, perception of the future etc. and side effects)	an average of 1 year
Secondary	Depression assessed with the HADS questionnaire	HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression	an average of 1 year