No registrations found.
ID
Source
Brief title
Health condition
Lumbar spinal stenosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in NRS
Secondary outcome
Opiod use,hospital stay, adverse events, patient satisfaction
Background summary
The objective of this study is to determine whether intraoperative epidural analgesia (bupivacaine/sufentanil) is superior to placebo in reducing wound pain in patients after decompressive lumbar spine surgery, and to determine whether opioid use in the 2 days after surgery is significantly higher in the placebo group.
Study objective
Epidural analgesia is superior to placebo in reducing post-operative pain.
Study design
First 48 hours post operative
Intervention
Epidural analgesia; Bolus 10ml of bupivacaine 0,125%-sufentanil 1 mcg/ml
Placebo 10ml of NaCl 0,9%
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.
Exclusion criteria
- Pre-operative opioid use (approximately 40% of patients)
- 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.
- Inadequate command of the Dutch language.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8030 |
| CCMO | NL71390.096.19 |
| OMON | NL-OMON49530 |