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Completed

NCT Number: NCT06383845

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

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.

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Key information

Conditions

Breast Surgery

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tunisia

Nabeul, 8000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lido-IV

Drug

Intravenous Lidocaine dose loading than a continuous infusion

Other names: Lidocaine-IV

ESP block

Drug

ultrasound guided block with injection of Ropivacaine

Other names: Erector Spinae Block

Primary outcomes

  1. Item 5 of Brief Pain inventory score (BPI Score)

    Time frame: item 5 of the BPI score evaluated as follows: 0 minimum score and 10 maximum score, at 01, 03 and 06 months post surgery

    Note of Brief Pain inventory Scale (BPI Score)

Secondary outcomes

  1. Acute pain assessed by Simple Verbal Scale (SVS)

    Time frame: Postoperatively, at Hour 2, Hour 12 and Hour 24

    Acute Postoperative pain was assessed by the Simple Verbal Scale (SVS)

  2. Postoperative nausea and vomiting

    Time frame: During the first 24hours postoperatively

    Incidence of postoperative nausea and vomiting during the first 24 hours

  3. Hospital length of stay

    Time frame: From the end of the surgery to discharge from the hospital

    hospital length of stay (in days)

  4. DN4 questionnaire (DN4)

    Time frame: 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

    DN4 questionnaire scale

  5. The short-form McGill Pain Questionnaire (SFM-PQ)

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

    The short-form McGill Pain Questionnaire Scale: Sensory and affective components of pain (11 sensory items and 4 affective items)

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 25, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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