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

March 31, 2018 updated by: Christophe Aveline, MD

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Cesson Sevigne, France, 35510
        • Christophe Aveline, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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 Names:
  • ATC code: N03AX16
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oxycodone consumption
Time Frame: 24h postoperatively
mg
24h postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) Pain at rest
Time Frame: the day before surgery
NRS: 0 no pain - 10 worst pain
the day before surgery
Numeric Rating Scale (NRS) Pain during walking
Time Frame: the day before surgery
NRS: 0 no pain - 10 worst pain
the day before surgery
Numeric Rating Scale Pain (NRS) at rest
Time Frame: 1h after surgery
NRS: 0 no pain - 10 worst pain
1h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time Frame: 4h after surgery
NRS: 0 no pain - 10 worst pain
4h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time Frame: 8h after surgery
NRS: 0 no pain - 10 worst pain
8h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time Frame: 12h after surgery
NRS: 0 no pain - 10 worst pain
12h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time Frame: 24h after surgery
NRS: 0 no pain - 10 worst pain
24h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time Frame: 48h after surgery
NRS: 0 no pain - 10 worst pain
48h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time Frame: 3 months after surgery
NRS: 0 no pain - 10 worst pain
3 months after surgery
Numeric Rating Scale Pain (NRS) during walking
Time Frame: 12h after surgery
NRS: 0 no pain - 10 worst pain
12h after surgery
Numeric Rating Scale Pain (NRS) during walking
Time Frame: 48h after surgery
NRS: 0 no pain - 10 worst pain
48h after surgery
Numeric Rating Scale Pain (NRS) during walking
Time Frame: 3 months ater surgery
NRS: 0 no pain - 10 worst pain
3 months ater surgery
remifentanil consumption
Time Frame: during surgery
µg/kg/min
during surgery
Morphine titration
Time Frame: 0-2h after surgery
mg
0-2h after surgery
Oxycodone requirement
Time Frame: 0-48h after surgery
mg
0-48h after surgery
Ondansetron requirement
Time Frame: 0-48h after surgery
mg
0-48h after surgery
DN4 score
Time Frame: preoperatively
preoperatively
DN4 score
Time Frame: on postoperative day one
on postoperative day one
DN4 score
Time Frame: on postoperative day two
on postoperative day two
DN4 score
Time Frame: three months after surgery
three months after surgery
length of stay
Time Frame: on postoperative day five
days
on postoperative day five
Post Opertive Nausea and vomiting (PONV)
Time Frame: 0-48h after surgery
% of patients
0-48h after surgery
Pregabalin side-effects
Time Frame: 0-48h after surgery
diplopia, confusion, dizziness, psychiatric disorders (% of patients)
0-48h after surgery
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
0-48h after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Christophe Aveline, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rennes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hélène Beloeil, MD, PhD, Rennes University Hospital
  • Principal Investigator: Christophe Aveline, MD, Private Hospital Sevigne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPH-016-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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