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Clinical trial

Comparison of Erector Spinae Plane Block and Intravenous Lidocaine for Chronic Pain Post Mastectomy: a Randomized Controlled Trial

ID
Name
MAS ESLI
Description
Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP). For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery. For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction. Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery.
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-01-31
Trial end
2024-09-30
Status
Active (not recruiting)
Treatment
Lido-IV
Intravenous Lidocaine dose loading than a continuous infusion
Arms:
Lidocaine-IV
Other names:
Lidocaine-IV
ESP Block
ultrasound guided block with injection of Ropivacaine
Arms:
Erector spinae Block
Other names:
Erector Spinae Block
Size
60
Primary endpoint
Item 5 of Brief Pain inventory score (BPI Score)
item 5 of the BPI score evaluated as follows: 0 minimum score and 10 maximum score, at 01, 03 and 06 months post surgery
Eligibility criteria
Inclusion Criteria: * Female patients * patients aged 18 and older * American Society of anesthesiologists classification I or II * patients proposed for planned mastectomy with axillary lymph node dissection. * hemodynamic stability. Exclusion Criteria: * patient refusal * male gender * history of major surgery within the year. * allergy to local anesthetics * BMI\>40 * hemodynamic instability * Patients on long-term analgesics * Severe heart and/or kidney damage * neurological/psychiatric impairment
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Erector spinae plane block VS intravenous lidocaine.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-04-25

1 organization

2 products

1 indication

Organization
University of Tunis El Manar
Product
Lido-IV
Indication
Breast Surgery
Product
ESP Block