Breast Surgery
Conditions
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.
Interventions
DRUGLido-IV
Intravenous Lidocaine dose loading than a continuous infusion
DRUGESP Block
ultrasound guided block with injection of Ropivacaine
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Erector spinae plane block VS intravenous lidocaine.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Tunisia
Outcome results
None listed