CompletedN/AOther

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

NCT ID

NCT02866396

Target Enrollment

70 participants

Start Date

2016-09

Est. Completion

2017-12

About This Study

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.

Conditions Studied

Postoperative PainNeuropathic Pain

Interventions

•Pregabalin
•Naive patient

Eligibility

Age:18 Years - 85 Years

Healthy Volunteers:No

View full 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

Study Locations (1)

Christophe Aveline, MD