Clinical trial NCT06383845: Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy.
Official title: Comparison of Erector Spinae Plane Block and Intravenous Lidocaine for Chronic Pain Post Mastectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Surgery
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Erector spinae plane block VS intravenous lidocaine.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Item 5 of Brief Pain inventory score (BPI Score)
timeFrame: 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:
measure: Acute pain assessed by Simple Verbal Scale (SVS)
timeFrame: Postoperatively, at Hour 2, Hour 12 and Hour 24
measure: Postoperative nausea and vomiting
timeFrame: During the first 24hours postoperatively
measure: Hospital length of stay
timeFrame: From the end of the surgery to discharge from the hospital
measure: DN4 questionnaire (DN4)
timeFrame: 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
measure: The short-form McGill Pain Questionnaire (SFM-PQ)
timeFrame: the 15 items are rated on a four-point pain intensity scale, at 01, 03 and 06 months after surgery
Other outcomes:
Locations:
city: Nabeul
country: Tunisia
facility: Tunisia
Study officials:
References: