Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy.
NCT ID: NCT06383845
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2023-01-01
2025-09-30
Brief Summary
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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.
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Detailed Description
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For Lido-IV group, patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 2 mg/kg/h till the end of surgery.
For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction with injection of 30 ml of Ropivacaine 3.75%.
For both group, persistant pain post mastectomy was assessed by Item 5 of BPI score at 1, 3 and 6 months post surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Lidocaine-IV
Intravenous Lidocaine dose loading than continuous infusion
Lido-IV
Intravenous Lidocaine dose loading than a continuous infusion
Erector spinae Block
An ultrasound guided Erector Spinae Block is performed with injection of 30 ml of Ropivacaine 3.75%
ESP Block
ultrasound guided block with injection of Ropivacaine
Interventions
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Lido-IV
Intravenous Lidocaine dose loading than a continuous infusion
ESP Block
ultrasound guided block with injection of Ropivacaine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
FEMALE
No
Sponsors
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University Tunis El Manar
OTHER
Responsible Party
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HibetAllah Ktata
Associate Professor
Locations
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Tunisia
Nabeul, , Tunisia
Countries
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Other Identifiers
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MAS ESLI
Identifier Type: -
Identifier Source: org_study_id
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