Lumbar spinal stenosis MedDRA version: 21.0 Level: LLT Classification code 10041595 Term: Spinal stenosis lumbar System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Bupivacaïne HCl 0,125% / Sufentanil 50 µg flacon à 50 ml
Product Name: Bupivacaine
Product Code: Sufentanil
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Indication for open interlaminar decompressive lumbar spine surgery. -Age over 18 years. -Psychosocially, mentally, and physically able to fully comply with this study protocol. -Informed consent prior to this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: -Pre-operative opiod use -Previous radiotherapy at the intended surgical level. -(Progressive) motor failure and/or anal sphincter disorders which urges instant intervention. -Active spinal infection. -Immature bone (ongoing growth). -Pregnancy. -Contra-indications for anesthesia or surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether epidural analgesia is superior to placebo, in reducing pain (measured in NRS) in patients after open lumbar decompression surgery.;Secondary Objective: To determine whether epidural analgesia leads to a reduction in cumulative opioid use until 48 hours postoperatively To determine whether epidural analgesia leads to higher patient satisfaction than placebo. To determine whether epidural analgesia leads to shorter hospital stay. To determine whether epidural analgesia leads to less adverse events. ;Primary end point(s): Postoperative pain scores (NRS) ;Timepoint(s) of evaluation of this end point: recovery entry, recovery exit, 2, 4, 6, 12, 24 and 48 hours postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Total postoperative opioid consumption at 48 hours postoperatively with interim measurements at 2, 4, 6, 12 and 24 hours. Patient satisfaction (measured by QoR-40), hospital stay in days, number of adverse events.;Timepoint(s) of evaluation of this end point: opioid consumption: 48 hours postoperatively with interim measurements at 2, 4, 6, 12 and 24 hours. patient satisfaction: 24 hours after surgery Hospital stay in days adverse events 30 days after surgery | — |
Countries
Netherlands
Outcome results
None listed