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Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement

NCT02866396 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2018-04-03

No results posted yet for this study

Summary

Spinal surgery is associated with intense pain and associated to a history of preoperative chronic pain. Pregabalin is licensed to treat chronic neuropathic pain, particularly when high dose of opioid are required. Preoperative pain is associated with high postoperative pain scores and opioid requirement promoting persistent hyperalgesic state. The investigators will evaluate the postoperative opioid consumption and pain scores in patients scheduled for lumbar surgery and taking pregabalin since more than 15 days and compare with preoperative pregabalin-free patient that will receive pregabalin only during surgery.

Conditions

  • Postoperative Pain
  • Neuropathic Pain

Interventions

DRUG

Pregabalin

Pregabalin continued at the same preoperative dose 1h before surgery associated to paracetamol 1g PO and ketoprofen 100mg PO Intraoperative: nefopam 20mg IV + ketamine 0.3mg/kg IV + dexamethasone 8mg IV Postoperative: morphine titration in PACU (NRS \> 3) + paracetamol 1g/6h PO + ketoprofen 100mg/12h PO systematically, oxycodone 5-10mg/12h PO if NRS\>3

OTHER

Naive patient

Pregabalin 150mg PO initiated 1h before surgery Associated to paracetamol 1g PO and ketoprofen 100mg PO Intraoperative: nefopam 20mg IV + ketamine 0.3mg/kg IV + dexamethasone 8mg IV Postoperative: morphine titration in PACU (NRS \> 3) + paracetamol 1g/6h PO + ketoprofen 100mg/12h PO systematically, oxycodone 5-10mg/12h PO if NRS\>3

Sponsors & Collaborators

  • Rennes University Hospital

    collaborator OTHER

  • Christophe Aveline, MD

    lead OTHER

Principal Investigators

  • Hélène Beloeil, MD, PhD · Rennes University Hospital

  • Christophe Aveline, MD · Private Hospital Sevigne

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-09-30
Completion
2017-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02866396 on ClinicalTrials.gov