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

Breast Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06383845
• Other study ID #: MAS ESLI
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Surgery
• Chronic Pain

Intervention

Drug:
• Lido-IV
Intravenous Lidocaine dose loading than a continuous infusion
• ESP Block
ultrasound guided block with injection of Ropivacaine

Locations

Country	Name	City	State
Tunisia	Tunisia	Nabeul

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting during the first 24 hours	During the first 24hours postoperatively
Secondary	Hospital length of stay	hospital length of stay (in days)	From the end of the surgery to discharge from the hospital
Secondary	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
Secondary	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