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Clinical Trials/EUCTR2019-003590-25-NL
EUCTR2019-003590-25-NL
Active, not recruiting
Phase 1

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

Not provided0 sites34 target enrollmentJune 15, 2020
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DrugsBupivacaïne HCl 0,125% / Sufentanil 50 µg flacon à 50 ml

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Not provided
Enrollment
34
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 15, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Not provided

Eligibility 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

  • •\-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.

Outcomes

Primary Outcomes

Not specified

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