a Randomized controlled trial for epidural Analgesia for Pain relief after lumbar Interlaminar Decompressive spine surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25260

Enrollment

Registered

2019-08-31

Start date

2020-01-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar spinal stenosis

Interventions

Epidural analgesia

Bolus 10ml of bupivacaine 0,125%-sufentanil 1 mcg/ml Placebo 10ml of NaCl 0,9%

Eligibility

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.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Difference in NRS	—

Secondary

Measure	Time frame
Opiod use,hospital stay, adverse events, patient satisfaction	—

Contacts

Public ContactAniek Lantinga-Zee

ZuyderlandMC

aniek_zee@hotmail.com0615962172

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)