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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

Tracking Information
First Submitted Date July 11, 2016
First Posted Date August 15, 2016
Last Update Posted Date April 3, 2018
Actual Study Start Date September 2016
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 10, 2016)
Oxycodone consumption [ Time Frame: 24h postoperatively ]
mg
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 14, 2016)
  • Numeric Rating Scale (NRS) Pain at rest [ Time Frame: the day before surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale (NRS) Pain during walking [ Time Frame: the day before surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 1h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 4h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 8h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 12h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 24h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 48h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 3 months after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) during walking [ Time Frame: 12h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) during walking [ Time Frame: 48h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) during walking [ Time Frame: 3 months ater surgery ]
    NRS: 0 no pain - 10 worst pain
  • remifentanil consumption [ Time Frame: during surgery ]
    µg/kg/min
  • Morphine titration [ Time Frame: 0-2h after surgery ]
    mg
  • Oxycodone requirement [ Time Frame: 0-48h after surgery ]
    mg
  • Ondansetron requirement [ Time Frame: 0-48h after surgery ]
    mg
  • DN4 score [ Time Frame: preoperatively ]
  • DN4 score [ Time Frame: on postoperative day one ]
  • DN4 score [ Time Frame: on postoperative day two ]
  • DN4 score [ Time Frame: three months after surgery ]
  • length of stay [ Time Frame: on postoperative day five ]
    days
  • Post Opertive Nausea and vomiting (PONV) [ Time Frame: 0-48h after surgery ]
    % of patients
  • Pregabalin side-effects [ Time Frame: 0-48h after surgery ]
    diplopia, confusion, dizziness, psychiatric disorders (% of patients)
  • 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
Original Secondary Outcome Measures
 (submitted: August 10, 2016)
  • Numeric Rating Scale (NRS) Pain at rest [ Time Frame: the day before surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale (NRS) Pain during walking [ Time Frame: the day before surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 1h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 4h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 8h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 12h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 24h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 48h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) at rest [ Time Frame: 3 months after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) during walking [ Time Frame: 12h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) during walking [ Time Frame: 48h after surgery ]
    NRS: 0 no pain - 10 worst pain
  • Numeric Rating Scale Pain (NRS) during walking [ Time Frame: 3 months ater surgery ]
    NRS: 0 no pain - 10 worst pain
  • remifentanil consumption [ Time Frame: during surgery ]
    µg/kg/min
  • Morphine titration [ Time Frame: 0-2h after surgery ]
    mg
  • Oxycodone requirement [ Time Frame: 0-48h after surgery ]
    mg
  • Ondansetron requirement [ Time Frame: 0-48h after surgery ]
    mg
  • DN4 score [ Time Frame: preoperatively ]
  • DN4 score [ Time Frame: on postoperative day one ]
  • DN4 score [ Time Frame: on postoperative day two ]
  • DN4 score [ Time Frame: three months after surgery ]
  • lenght of stay [ Time Frame: on postoperative day five ]
    days
  • PONV [ Time Frame: 0-48h after surgery ]
    % of patients
  • Pregabalin side-effects [ Time Frame: 0-48h after surgery ]
    diplopia, confusion, dizziness, psychiatric disorders (% of patients)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement
Official Title Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Postoperative Pain
  • Neuropathic Pain
Intervention
  • 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
  • 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
Study Groups/Cohorts
  • 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
    Intervention: Drug: Pregabalin
  • 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
    Intervention: Other: Naive patient
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 10, 2016)
70
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02866396
Other Study ID Numbers SPH-016-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Christophe Aveline, MD, Private Hospital Sevigne
Study Sponsor Christophe Aveline, MD
Collaborators Rennes University Hospital
Investigators
Study Chair: Hélène Beloeil, MD, PhD Rennes University Hospital
Principal Investigator: Christophe Aveline, MD Private Hospital Sevigne
PRS Account Private Hospital Sevigne
Verification Date March 2018