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

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ClinicalTrials.gov Identifier: NCT02866396
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Rennes University Hospital
Information provided by (Responsible Party):
Christophe Aveline, MD, Private Hospital Sevigne

Brief 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.

Condition or disease Intervention/treatment
Postoperative Pain Neuropathic Pain Drug: Pregabalin Other: Naive patient

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pregabalin patients
Same dose of preoperative pregabalin 1h after 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 (PACU if NRS > 3) + paracetamol 1g/6h PO + ketoprofen 100mg/12h PO systematically, oxycodone 5-10mg/12h PO if NRS>3
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 Name: ATC code: N03AX16

Naive patients
Pregabalin 150mg PO initiated 1h before surgery and 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




Primary Outcome Measures :
  1. Oxycodone consumption [ Time Frame: 24h postoperatively ]
    mg


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The investigators will evaluate the postoperative opioid consumption and pain scores in patients scheduled for lumbar spine surgery and taking pregabalin since more than 15 days and compare with preoperative pregabalin-free patient that will receive pregabalin only during surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866396


Locations
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France
Christophe Aveline, MD
Cesson Sevigne, France, 35510
Sponsors and Collaborators
Christophe Aveline, MD
Rennes University Hospital
Investigators
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Study Chair: Hélène Beloeil, MD, PhD Rennes University Hospital
Principal Investigator: Christophe Aveline, MD Private Hospital Sevigne

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Responsible Party: Christophe Aveline, MD, Principal investigator: Christophe Aveline, Department of anesthesia and surgical intensive care unit, Private Hospital, Private Hospital Sevigne
ClinicalTrials.gov Identifier: NCT02866396     History of Changes
Other Study ID Numbers: SPH-016-A
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christophe Aveline, MD, Private Hospital Sevigne:
chronic pain
oxycodone
pregabalin
lumbar spine surgery
multimodal analgesia

Additional relevant MeSH terms:
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Neuralgia
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Acetaminophen
Dexamethasone
Dexamethasone acetate
Ketoprofen
Pregabalin
Morphine
Oxycodone
Ketamine
Nefopam
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal