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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Surgery
• Intervention / Treatment: Drug: Lido-IV; Drug: ESP Block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Nabeul, Tunisia, 8000
    • Tunisia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine-IV; Intravenous Lidocaine dose loading than continuous infusion	Drug: Lido-IV; Intravenous Lidocaine dose loading than a continuous infusion; Other Names: Lidocaine-IV
Active Comparator: Erector spinae Block; An ultrasound guided Erector Spinae Block is performed with injection of 30 ml of Ropivacaine 3.75%	Drug: ESP Block; ultrasound guided block with injection of Ropivacaine; Other Names: Erector Spinae Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Item 5 of Brief Pain inventory score (BPI Score)	Note of Brief Pain inventory Scale (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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute pain assessed by Simple Verbal Scale (SVS)	Acute Postoperative pain was assessed by the Simple Verbal Scale (SVS)	Postoperatively, at Hour 2, Hour 12 and Hour 24
Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting during the first 24 hours	During the first 24hours postoperatively
Hospital length of stay	hospital length of stay (in days)	From the end of the surgery to discharge from the hospital
DN4 questionnaire (DN4)	DN4 questionnaire scale	DN4 represented by 10 items with a score from a minimum of 0 to a maximum of 10, at 03 and 06 months post surgery
The short-form McGill Pain Questionnaire (SFM-PQ)	The short-form McGill Pain Questionnaire Scale: Sensory and affective components of pain (11 sensory items and 4 affective items)	the 15 items are rated on a four-point pain intensity scale, at 01, 03 and 06 months after surgery

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: April 14, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: MAS ESLI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No