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

Completed

Conditions: Lumbar spinal stenosis
narrowing of the spinal canal
10028377
10041543
10009720

Registration Number: NL-OMON49530

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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

- Intraoperative technical (5% of cases) or medical (because of a dural tear in
8% of cases) reason in which placement of epidural catheter is not feasible or
safe.
-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 bupivacaine or other amide type local anesthetics,
anesthesia or surgery.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postoperative pain scores (NRS) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Difference between NRS pain score in the intervention group (epidural<br /><br>bupivacaine) and standard care (Intraveneous morphine). Total postoperative<br /><br>opioid consumption at 48 hours postoperatively with interim measurements at 2,<br /><br>4, 6 and 24 hours. Patient satisfaction (measured by EQ-5D and GSRI), hospital<br /><br>stay in days, number of adverse events.</p><br>