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

NCT06383845 | Completed

• 1 other identifier: MAS ESLI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Acute pain assessed by Simple Verbal Scale (SVS)

  Postoperatively, at Hour 2, Hour 12 and Hour 24

• Postoperative nausea and vomiting

  During the first 24hours postoperatively

• Hospital length of stay

  From the end of the surgery to discharge from the hospital

• DN4 questionnaire (DN4)

  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 15 items are rated on a four-point pain intensity scale, at 01, 03 and 06 months after surgery

Study Arms (2)

Lidocaine-IV

EXPERIMENTAL

Intravenous Lidocaine dose loading than continuous infusion

Drug: Lido-IV

Erector spinae Block

ACTIVE COMPARATOR

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

Drug: ESP Block

Interventions

Lido-IV DRUG

Intravenous Lidocaine dose loading than a continuous infusion

Also known as: Lidocaine-IV

Lidocaine-IV

ESP Block DRUG

ultrasound guided block with injection of Ropivacaine

Also known as: Erector Spinae Block

Erector spinae Block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Tunisia

Nabeul, 8000, Tunisia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Erector spinae plane block VS intravenous lidocaine.

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 25, 2024
• Study Start: January 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: September 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TU (1)