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

Postoperative Pain Clinical Trial

— PREGAB  

Official title:

Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866396
• Other study ID #: SPH-016-A
• Status: Completed
• First received: July 11, 2016
• Last updated: March 31, 2018
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Private Hospital Sevigne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain, Postoperative
• Postoperative 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:
• 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

Locations

Country	Name	City	State
France	Christophe Aveline, MD	Cesson Sevigne

Sponsors (2)

Lead Sponsor	Collaborator
Christophe Aveline, MD	Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxycodone consumption	mg	24h postoperatively
Secondary	Numeric Rating Scale (NRS) Pain at rest	NRS: 0 no pain - 10 worst pain	the day before surgery
Secondary	Numeric Rating Scale (NRS) Pain during walking	NRS: 0 no pain - 10 worst pain	the day before surgery
Secondary	Numeric Rating Scale Pain (NRS) at rest	NRS: 0 no pain - 10 worst pain	1h after surgery
Secondary	Numeric Rating Scale Pain (NRS) at rest	NRS: 0 no pain - 10 worst pain	4h after surgery
Secondary	Numeric Rating Scale Pain (NRS) at rest	NRS: 0 no pain - 10 worst pain	8h after surgery
Secondary	Numeric Rating Scale Pain (NRS) at rest	NRS: 0 no pain - 10 worst pain	12h after surgery
Secondary	Numeric Rating Scale Pain (NRS) at rest	NRS: 0 no pain - 10 worst pain	24h after surgery
Secondary	Numeric Rating Scale Pain (NRS) at rest	NRS: 0 no pain - 10 worst pain	48h after surgery
Secondary	Numeric Rating Scale Pain (NRS) at rest	NRS: 0 no pain - 10 worst pain	3 months after surgery
Secondary	Numeric Rating Scale Pain (NRS) during walking	NRS: 0 no pain - 10 worst pain	12h after surgery
Secondary	Numeric Rating Scale Pain (NRS) during walking	NRS: 0 no pain - 10 worst pain	48h after surgery
Secondary	Numeric Rating Scale Pain (NRS) during walking	NRS: 0 no pain - 10 worst pain	3 months ater surgery
Secondary	remifentanil consumption	µg/kg/min	during surgery
Secondary	Morphine titration	mg	0-2h after surgery
Secondary	Oxycodone requirement	mg	0-48h after surgery
Secondary	Ondansetron requirement	mg	0-48h after surgery
Secondary	DN4 score		preoperatively
Secondary	DN4 score		on postoperative day one
Secondary	DN4 score		on postoperative day two
Secondary	DN4 score		three months after surgery
Secondary	length of stay	days	on postoperative day five
Secondary	Post Opertive Nausea and vomiting (PONV)	% of patients	0-48h after surgery
Secondary	Pregabalin side-effects	diplopia, confusion, dizziness, psychiatric disorders (% of patients)	0-48h after surgery
Secondary	Sedation	1: awake - 2: drowsiness, easily awake by appeal - 3: drowsiness, awake to tactile stimulation - 4: drowsiness, awake by pain	0-48h after surgery