Christophe Aveline, MD
Cesson-Sévigné, 35510, France
NCT Number: NCT02866396
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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Notify Me18 year–85 year
All sexes
Observational
Cesson-Sévigné, 35510, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 24h postoperatively
mg
Time frame: the day before surgery
NRS: 0 no pain - 10 worst pain
Time frame: the day before surgery
NRS: 0 no pain - 10 worst pain
Time frame: 1h after surgery
NRS: 0 no pain - 10 worst pain
Time frame: 4h after surgery
NRS: 0 no pain - 10 worst pain
Time frame: 8h after surgery
NRS: 0 no pain - 10 worst pain
Time frame: 12h after surgery
NRS: 0 no pain - 10 worst pain
Time frame: 24h after surgery
NRS: 0 no pain - 10 worst pain
Time frame: 48h after surgery
NRS: 0 no pain - 10 worst pain
Time frame: 3 months after surgery
NRS: 0 no pain - 10 worst pain
Time frame: 12h after surgery
NRS: 0 no pain - 10 worst pain
Time frame: 48h after surgery
NRS: 0 no pain - 10 worst pain
Time frame: 3 months ater surgery
NRS: 0 no pain - 10 worst pain
Time frame: during surgery
µg/kg/min
Time frame: 0-2h after surgery
mg
Time frame: 0-48h after surgery
mg
Time frame: 0-48h after surgery
mg
Time frame: preoperatively
Time frame: on postoperative day one
Time frame: on postoperative day two
Time frame: three months after surgery
Time frame: on postoperative day five
days
Time frame: 0-48h after surgery
% of patients
Time frame: 0-48h after surgery
diplopia, confusion, dizziness, psychiatric disorders (% of patients)
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
Christophe Aveline, MD
Other
Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study
Acronym: PREGAB
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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