Postoperative pain following scoliosis surgery
Conditions
Interventions
Trade Name: Levobupivacaine
Product Name: Levobupivacaine
Pharmaceutical Form: Solution for infusion
Sponsors
Hospital Universitario Fundación Alcorcón
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients older than 16 years old - Elective scoliosis surgery involving more than 4 spaces - ASA I-III - Primary surgery and reinterventions - Idiopathic and degenerative scoliosis Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Urgent surgery - Infection in the site of surgery - Allergy to any of the drugs used in the study. - Patient refusal - Absence of informed consent - Surgical complication that prevents an adequate follow up (i.e. hemorrhage, delirium, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of erector spinae plane catheters following scoliosis surgery involving more than 4 levels;Secondary Objective: To determine morphine consumption, pain scores, time to first mobilisation, sitting and standing, and hospital stay.;Primary end point(s): Morphine consumption in the first 24 postoperative hours;Timepoint(s) of evaluation of this end point: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine morphine consumption during the first 3 days, pain scores (VAS) at 0,2,6,12,24,48 and 72 hours, time to first mobilisation, sitting and standing, time of hospital stay and development of surgical site infection.;Timepoint(s) of evaluation of this end point: During hospital stay and 30 days after discharge | — |
Countries
Spain
Contacts
Public ContactDepartment of Anesthesiology
Hospital Universitario Fundación Alcorcón
Outcome results
None listed