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Completed

NCT Number: NCT02866396

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

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.

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Key information

About this study

Patients will be prospectively included and compared according their preoperative medication: pregabalin-treated patients (>more than 15 days) for neuropathic pain associated to spinal surgery and pregabalin-free patients for whom pregabalin will be prescribed for 48 hours. Patients will be included without randomization as an observational study. All the patients will receive multimodal analgesia and intraoperative management will be standardized. The main outcome will be the amount of oxycodone during the first 24h after surgery. Other outcomes include pain scores, the quantification of the neuropathic pain diagnostic questionnaire (DN4), nausea and vomiting, length of stay, side-effects of pregabalin and opioid. Patients were also evaluated at three months for pain scores and DN4 score. Postoperative evaluation will be performed in a single-blind manner with investigators not include in the recruitment or the peroperative period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society Anesthesiologist Physical status (ASA) 1-3
  • Age ≥18 years old
  • Spinal surgery: discectomy, posterior or transforaminal lumbar interbody fusion limited to 2 levels, lumbar disk prosthesis
  • Able to participate personality, has given free and inform consent in French
  • Affiliated of beneficiary of a system of social security

Exclusion criteria

  • Age less than 18 years or higher than 85 years old
  • Refusal to participate or provide written consent
  • Surgery with a combined anterior and posterior approach
  • Emergency surgery, reintervention, spine fracture, metastasis
  • Tricyclic antidepressant use
  • Pregabalin use for other indication: other neuropathy, epilepsy, generalized anxiety disorder
  • Pregnancy
  • Lack of understanding of NRS and/or DN4 scores
  • Hypersensibility or contraindication to levobupivacaine, paracetamol, nefopam, ketoprofen and/or oxycodone
  • Participation in another clinical study

Treatment and study plan

Pregabalin

Drug

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 names: ATC code: N03AX16

Naive patient

Other

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

Primary outcomes

  1. Oxycodone consumption

    Time frame: 24h postoperatively

    mg

Secondary outcomes

  1. Numeric Rating Scale (NRS) Pain at rest

    Time frame: the day before surgery

    NRS: 0 no pain - 10 worst pain

  2. Numeric Rating Scale (NRS) Pain during walking

    Time frame: the day before surgery

    NRS: 0 no pain - 10 worst pain

  3. Numeric Rating Scale Pain (NRS) at rest

    Time frame: 1h after surgery

    NRS: 0 no pain - 10 worst pain

  4. Numeric Rating Scale Pain (NRS) at rest

    Time frame: 4h after surgery

    NRS: 0 no pain - 10 worst pain

  5. Numeric Rating Scale Pain (NRS) at rest

    Time frame: 8h after surgery

    NRS: 0 no pain - 10 worst pain

  6. Numeric Rating Scale Pain (NRS) at rest

    Time frame: 12h after surgery

    NRS: 0 no pain - 10 worst pain

  7. Numeric Rating Scale Pain (NRS) at rest

    Time frame: 24h after surgery

    NRS: 0 no pain - 10 worst pain

  8. Numeric Rating Scale Pain (NRS) at rest

    Time frame: 48h after surgery

    NRS: 0 no pain - 10 worst pain

  9. Numeric Rating Scale Pain (NRS) at rest

    Time frame: 3 months after surgery

    NRS: 0 no pain - 10 worst pain

  10. Numeric Rating Scale Pain (NRS) during walking

    Time frame: 12h after surgery

    NRS: 0 no pain - 10 worst pain

  11. Numeric Rating Scale Pain (NRS) during walking

    Time frame: 48h after surgery

    NRS: 0 no pain - 10 worst pain

  12. Numeric Rating Scale Pain (NRS) during walking

    Time frame: 3 months ater surgery

    NRS: 0 no pain - 10 worst pain

  13. remifentanil consumption

    Time frame: during surgery

    µg/kg/min

  14. Morphine titration

    Time frame: 0-2h after surgery

    mg

  15. Oxycodone requirement

    Time frame: 0-48h after surgery

    mg

  16. Ondansetron requirement

    Time frame: 0-48h after surgery

    mg

  17. DN4 score

    Time frame: preoperatively

  18. DN4 score

    Time frame: on postoperative day one

  19. DN4 score

    Time frame: on postoperative day two

  20. DN4 score

    Time frame: three months after surgery

  21. length of stay

    Time frame: on postoperative day five

    days

  22. Post Opertive Nausea and vomiting (PONV)

    Time frame: 0-48h after surgery

    % of patients

  23. Pregabalin side-effects

    Time frame: 0-48h after surgery

    diplopia, confusion, dizziness, psychiatric disorders (% of patients)

  24. Sedation

    Time frame: 0-48h after surgery

    1: awake - 2: drowsiness, easily awake by appeal - 3: drowsiness, awake to tactile stimulation - 4: drowsiness, awake by pain

Sponsors and collaborators

Lead sponsor

Christophe Aveline, MD

Other

Collaborators

  • Rennes University Hospital

Registry information

Official study title

Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study

Acronym: PREGAB

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2016
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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