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

Not Applicable

Active, not recruiting

• Conditions: Breast Surgery
• Interventions: Drug: ESP Block; Drug: Lido-IV

• Registration Number: NCT06383845
• Lead Sponsor: University Tunis El Manar

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.

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 Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-01-31
• Study First Submitted: 2024-04-14
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Study Completion: 2025-05-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinae Block	ESP Block	An ultrasound guided Erector Spinae Block is performed with injection of 30 ml of Ropivacaine 3.75%
Lidocaine-IV	Lido-IV	Intravenous Lidocaine dose loading than continuous infusion

Primary Outcome Measures

Name	Time	Method
Item 5 of Brief Pain inventory score (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	Note of Brief Pain inventory Scale (BPI Score)

Secondary Outcome Measures

Name	Time	Method
Acute pain assessed by Simple Verbal Scale (SVS)	Postoperatively, at Hour 2, Hour 12 and Hour 24	Acute Postoperative pain was assessed by the Simple Verbal Scale (SVS)
Postoperative nausea and vomiting	During the first 24hours postoperatively	Incidence of postoperative nausea and vomiting during the first 24 hours
Hospital length of stay	From the end of the surgery to discharge from the hospital	hospital length of stay (in days)
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	DN4 questionnaire scale
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	The short-form McGill Pain Questionnaire Scale: Sensory and affective components of pain (11 sensory items and 4 affective items)

Trial Locations

Locations (1)

Tunisia; 🇹🇳 Nabeul, Tunisia