ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery

Breast Surgery Clinical Trial

— ER-One  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827030
• Other study ID #: IC 2020-04
• Status: Completed
• Phase: Phase 4
• Start date: June 28, 2021
• Est. completion date: July 14, 2023

Study information

• Verified date: August 2023
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The block will be performed with IV Remifentanil sedation Target-Controlled Infusion mode at 2ng/ml and oxygen therapy. For the erector spinae plane block: The puncture will be performed with ultrasound guidance. The ultrasound probe will be placed parallel to the spine parasagittally at the T3 transverse process level. The needle will be introduced and visualized to the plane of the ultrasound image ("in plane"). The desired injection site is between the fascia of the erector muscle of the spine and the transverse process at the T3 level. The operator ensures the correct localization of the needle with saline solution. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml. For paravertebral block: The T2 intervertebral space will be located by identifying compared to C7, a prominent cervical vertebra, or by ultrasound by counting the thoracic vertebrae from the first rib. The paravertebral space will be identified by placing the ultrasound probe in a parasagittal or transverse position. The needle will go through the paravertebral muscles and the costo-transverse ligament or by a latero-medial approach using ultrasound. The block will be performed using a 22-gauge 8cm long needle. When the paravertebral space has been reach, an aspiration test will be performed and then 0.6 ml/kg of solution (Ropivacaine hydrochloride solution at 5 mg/ml up to 30 ml) will be injected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: July 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Surgery

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	AP-HP Hôpital Tenon	Paris
France	Institut Curie	Saint-Cloud
France	Institut Claudius Régaud UICT	Toulouse
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Institut Curie	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of ESP versus PVB on acute postoperative pain	Percentage of patients needed morphine during the first two postoperative hours in each treatment arm	24 hours
Secondary	Postoperative morphine consumption	Dose of opioid, in the Post-Anesthesia Care Unit (PACU)	2 hours
Secondary	Consumption of remifentanil in the Operating Room (OR)	Dose of Remifentanil during the Operating Room (OR) period	During the period from the surgical incision to the end of the surgical dissection
Secondary	Acute early postoperative pain by Visual Analog Scale (VAS)	VAS (no pain=0, worst pain=10) at arrival in the PACU, every 30 minutes in the Post-Anaesthesia Care Unit (PACU), VAS at 4 and 24 hours. Pain scores will be evaluated at rest and after shoulder movement	24 hours
Secondary	Percentage of nausea or vomiting	Number of patient who related nausea or vomiting side effects will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0)	2 hours
Secondary	Incidence of complications and side effects of each block	Complications and side effects of each block will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0)	30 days
Secondary	Post-operative extend of dermatomes blocked	The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change	2 hours