Clinical Trials Logo

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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03618433 - KÄ°NECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery N/A
Terminated NCT05395936 - Mastectomy Flap Temperature Study N/A
Recruiting NCT03757793 - Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
Completed NCT01781299 - Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU Phase 4
Completed NCT01176786 - Reusable Versus Disposable Draping System in Breast Reconstruction Surgery N/A
Terminated NCT00616824 - The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction Phase 4
Recruiting NCT06033456 - Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome N/A
Recruiting NCT05975359 - Assessment of the Interi Manifold in Implant-Based Breast Reconstruction N/A
Withdrawn NCT03135392 - Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer N/A
Recruiting NCT01217593 - Ultrasound vs. Predetermined Distance Techniques for Paravertebral Nerve Block in Patients Having Breast Surgery N/A
Completed NCT01231204 - Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks Phase 4
Recruiting NCT05069805 - Comparison of Erector Spinae Plane Block and Pectoral Nerve Block for Acute and Chronic Pain in Mastectomies N/A
Completed NCT01687348 - Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy Phase 3
Completed NCT00555503 - Registry of Mastectomy for Breast Cancer Risk Reduction N/A
Recruiting NCT03598712 - Local Compression Seroma DIminution Objective (CLODIS) Phase 3
Not yet recruiting NCT04457167 - Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not. N/A
Recruiting NCT05494502 - Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients N/A
Recruiting NCT02894021 - PREvention of Post-mastectomy LYMphoceles by PAdding N/A
Recruiting NCT04891510 - A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery N/A
Enrolling by invitation NCT05658367 - Effect of Aromatherapy Massage on Pain and Anxiety After Mastectomy N/A