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

Ketamine

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.

Intervention / Treatment

  • 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
  • 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

Condition or Disease

  • Postoperative Pain
  • Neuropathic Pain

Phase

Study Design

Study type: OBSERVATIONAL
Status: Completed
Study results: No Results Available
Age: 18 Years to 85 Years
Enrollment: 70 (ACTUAL)
Funded by: Other
Time Perspective: Prospective
Observational Model: Cohort

Masking

Clinical Trial Dates

Start date: Sep 01, 2016 ACTUAL
Primary Completion: Sep 01, 2017 ACTUAL
Completion Date: Dec 01, 2017 ACTUAL
Study First Posted: Aug 15, 2016 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: Mar 31, 2018

Sponsors / Collaborators

Lead Sponsor: Christophe Aveline, MD
Responsible Party: Christophe Aveline, MD

Location

Cesson Sevigne, Brittany, 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.

Participant Groups

  • 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

  • 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

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 85
Age Groups: Adult / Older Adult
Healthy Volunteers: Yes

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

Primary Outcomes

  • mg

Secondary Outcomes

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • NRS: 0 no pain - 10 worst pain

  • µg/kg/min

  • mg

  • mg

  • mg

  • DN4 score preoperatively
  • DN4 score on postoperative day one
  • DN4 score on postoperative day two
  • DN4 score three months after surgery

  • days

  • % of patients

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

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

More Details

NCT Number: NCT02866396
Acronym: PREGAB
Other IDs: SPH-016-A
Study URL: https://clinicaltrials.gov/study/NCT02866396
Last updated: Sep 29, 2023