Clinical trial
A Double-blind Randomized Non-inferiority Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery: Effects on Acute Postoperative Pain.
Name
IC 2020-04
Description
The block (ESP or PVB) will be performed preoperatively in the recovery room under standard monitoring. After setting a peripheral venous access, patient will be installed on lateral decubitus position on the opposite side of the block.
Trial arms
Trial start
2021-06-28
Estimated PCD
2023-06-14
Trial end
2023-07-14
Status
Completed
Phase
Early phase I
Treatment
Ropivacaïne Hydrochloride by Erector Spinae block
Ropivacaïne Hydrochloride Erector Spinae puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.
Arms:
Ropivacaine hydrochloride injected by Erector Spinae block
Other names:
Naropin
Ropivacaïne Hydrochloride by Paravertebral block
Paravertebral puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.
Arms:
Ropivacaine hydrochloride injected by Paravertebral block
Other names:
Naropin
Size
292
Primary endpoint
Comparison of ESP versus PVB on acute postoperative pain
24 hours
Eligibility criteria
Inclusion Criteria:
1. Woman with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma (with or without breast reconstruction by prosthesis) to by treated:
* either by breast-conserving surgery with axillary dissection,
* either by modified radical mastectomy with axillary dissection
* either by modified radical mastectomy with lymph node dissection
* either by modified radical mastectomy without axillary
2. Patients aged between 18 and 85 years old.
3. ASA class 1, 2 or 3 (Physical Status Classification System of American Society of Anesthesiologists (ASA)).
4. Signed informed consent form.
5. Patient able to answer self-assessment questionnaires (sufficient understanding of evaluations and in French).
6. Patient affiliated to the health care insurance.
Exclusion Criteria:
1. Preoperative consumption of opioid in the patient's current medications within three months before inclusion.
2. Ipsilateral breast surgery during 3 months prior to the inclusion.
3. Allergy to local anaesthetics and morphine and NSAID.
4. Local skin inflammation at the puncture area.
5. Bilateral breast surgery planned at inclusion.
6. Major immediate ipsilateral breast reconstruction by using tissue flap procedure (example: latissimus dorsi flap, Deep Inferior Epigastric Perforator (DIEP), Transverse Rectus Abdominis Musculocutaneous (TRAM)...).
7. Any contra-indication or patient's refusal for regional anesthesia.
8. Male subjects.
9. Pregnant woman or breastfeeding.
10. B blocker medication.
11. Patient already participating in an analgesia protocol that may interfere with the pain assessment criteria.
12. Patient under legal protection.
13. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Double-blind Randomized non-inferiority Trial of erector spinae block (ESP) versus paravertebral block (PVB)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 292, 'type': 'ACTUAL'}}
Updated at
2024-01-29
1 organization
1 product
1 indication
Organization
Institut CurieProduct
Ropivacaine HydrochlorideIndication
Breast Surgery