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

University Tunis El Manar

Status: Completed

Conditions: Breast Surgery

Treatments: Drug: Lido-IV; Drug: ESP Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06383845

MAS ESLI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Lidocaine-IV

Experimental group

Description:

Intravenous Lidocaine dose loading than continuous infusion

Treatment:

Drug: Lido-IV

Erector spinae Block

Active Comparator group

Description:

An ultrasound guided Erector Spinae Block is performed with injection of 30 ml of Ropivacaine 3.75%

Treatment:

Drug: ESP Block