Epidural analgesia after back surgery

Phase 1

• Conditions: umbar spinal stenosis; MedDRA version: 21.0Level: LLTClassification code 10041595Term: Spinal stenosis lumbarSystem Organ Class: 100000004859; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2019-003590-25-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-15
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 34

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>To determine whether epidural analgesia leads to higher patient satisfaction than placebo.<br>To determine whether epidural analgesia leads to shorter hospital stay.<br>To determine whether epidural analgesia leads to less adverse events.<br>;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 Outcome Measures

Name	Time	Method
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. <br>patient satisfaction: 24 hours after surgery<br>Hospital stay in days<br>adverse events 30 days after surgery