Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy.

NCT ID: NCT06383845

Last Updated: 2025-11-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Patients undergoing breast surgery with lymph node dissection were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).

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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Breast Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Erector spinae plane block VS intravenous lidocaine.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Lidocaine-IV

Intravenous Lidocaine dose loading than continuous infusion

Group Type EXPERIMENTAL

Lido-IV

Intervention Type DRUG

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%

Group Type ACTIVE_COMPARATOR

ESP Block

Intervention Type DRUG

ultrasound guided block with injection of Ropivacaine

Interventions

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Lido-IV

Intravenous Lidocaine dose loading than a continuous infusion

Intervention Type DRUG

ESP Block

ultrasound guided block with injection of Ropivacaine

Intervention Type DRUG

Other Intervention Names

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Lidocaine-IV Erector Spinae Block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Tunis El Manar

OTHER

Sponsor Role lead

Responsible Party

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HibetAllah Ktata

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tunisia

Nabeul, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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MAS ESLI

Identifier Type: -

Identifier Source: org_study_id

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