Postoperative PainPREGABNCT02866396
Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement
An observational study of Postoperative Pain and Neuropathic Pain, run by Christophe Aveline, MD at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Neuropathic Pain
- What is being tested?
- Pregabalin and Naive patient
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Neuropathic Pain
- Being tested
- Pregabalin, Naive patient
- Keywords
- chronic pain, oxycodone, pregabalin, lumbar spine surgery, multimodal analgesia
- Medical subject headings
- Pain, Postoperative, Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called ATC code: N03AX16
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 patientOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Pregabalin | |
| 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 Receives: Other: Naive patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxycodone consumption
mg
Measured: 24h postoperatively
Secondary outcomes (24)
Numeric Rating Scale (NRS) Pain at rest
NRS: 0 no pain - 10 worst pain
Measured: the day before surgery
Numeric Rating Scale (NRS) Pain during walking
NRS: 0 no pain - 10 worst pain
Measured: the day before surgery
Numeric Rating Scale Pain (NRS) at rest
NRS: 0 no pain - 10 worst pain
Measured: 1h after surgery
Numeric Rating Scale Pain (NRS) at rest
NRS: 0 no pain - 10 worst pain
Measured: 4h after surgery
Numeric Rating Scale Pain (NRS) at rest
NRS: 0 no pain - 10 worst pain
Measured: 8h after surgery
Numeric Rating Scale Pain (NRS) at rest
NRS: 0 no pain - 10 worst pain
Measured: 12h after surgery
Numeric Rating Scale Pain (NRS) at rest
NRS: 0 no pain - 10 worst pain
Measured: 24h after surgery
Numeric Rating Scale Pain (NRS) at rest
NRS: 0 no pain - 10 worst pain
Measured: 48h after surgery
Numeric Rating Scale Pain (NRS) at rest
NRS: 0 no pain - 10 worst pain
Measured: 3 months after surgery
Numeric Rating Scale Pain (NRS) during walking
NRS: 0 no pain - 10 worst pain
Measured: 12h after surgery
Numeric Rating Scale Pain (NRS) during walking
NRS: 0 no pain - 10 worst pain
Measured: 48h after surgery
Numeric Rating Scale Pain (NRS) during walking
NRS: 0 no pain - 10 worst pain
Measured: 3 months ater surgery
remifentanil consumption
µg/kg/min
Measured: during surgery
Morphine titration
mg
Measured: 0-2h after surgery
Oxycodone requirement
mg
Measured: 0-48h after surgery
Ondansetron requirement
mg
Measured: 0-48h after surgery
DN4 score
Measured: preoperatively
DN4 score
Measured: on postoperative day one
DN4 score
Measured: on postoperative day two
DN4 score
Measured: three months after surgery
length of stay
days
Measured: on postoperative day five
Post Opertive Nausea and vomiting (PONV)
% of patients
Measured: 0-48h after surgery
Pregabalin side-effects
diplopia, confusion, dizziness, psychiatric disorders (% of patients)
Measured: 0-48h after surgery
Sedation
1: awake - 2: drowsiness, easily awake by appeal - 3: drowsiness, awake to tactile stimulation - 4: drowsiness, awake by pain
Measured: 0-48h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christophe Aveline, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Rennes University Hospital
- Responsible party
- Sponsor-investigator, Christophe Aveline, MD, Private Hospital Sevigne
- Investigators
- Hélène Beloeil, MD, PhD, Study chair, Rennes University HospitalChristophe Aveline, MD, Principal investigator, Private Hospital Sevigne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866396
- Sponsor's protocol ID
- SPH-016-A
- Acronym
- PREGAB
- Status last verified
- Mar 2018
- First submitted
- 11 Jul 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT02866396
- Acronym / sponsor ID
- PREGAB / SPH-016-A
- Conditions
- Postoperative Pain, Neuropathic Pain
- Keywords
- chronic pain, oxycodone, pregabalin, lumbar spine surgery, multimodal analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Christophe Aveline, MDUniversity, hospital or other
- Collaborators
- Rennes University Hospital
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin patients | – | Drug: PregabalinSame 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 |
| Naive patients | – | Other: Naive patientPregabalin 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: ATC code: N03AX16Pregabalin 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 | Drug | Pregabalin patients |
| Naive patientPregabalin 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 | Other | Naive patients |
Primary outcome
Oxycodone consumption
Time frame: 24h postoperatively
mg
24 secondary outcomes
Numeric Rating Scale (NRS) Pain at rest
Time frame: the day before surgery
Numeric Rating Scale (NRS) Pain during walking
Time frame: the day before surgery
Numeric Rating Scale Pain (NRS) at rest
Time frame: 1h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time frame: 4h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time frame: 8h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time frame: 12h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time frame: 24h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time frame: 48h after surgery
Numeric Rating Scale Pain (NRS) at rest
Time frame: 3 months after surgery
Numeric Rating Scale Pain (NRS) during walking
Time frame: 12h after surgery
Numeric Rating Scale Pain (NRS) during walking
Time frame: 48h after surgery
Numeric Rating Scale Pain (NRS) during walking
Time frame: 3 months ater surgery
remifentanil consumption
Time frame: during surgery
Morphine titration
Time frame: 0-2h after surgery
Oxycodone requirement
Time frame: 0-48h after surgery
Ondansetron requirement
Time frame: 0-48h after surgery
DN4 score
Time frame: preoperatively
DN4 score
Time frame: on postoperative day one
DN4 score
Time frame: on postoperative day two
DN4 score
Time frame: three months after surgery
length of stay
Time frame: on postoperative day five
Post Opertive Nausea and vomiting (PONV)
Time frame: 0-48h after surgery
Pregabalin side-effects
Time frame: 0-48h after surgery
Sedation
Time frame: 0-48h after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Beloeil, MD, PhD study chair
Rennes University Hospital
Christophe Aveline, MD principal investigator
Private Hospital Sevigne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Neuropathic Pain, run by Christophe Aveline, MD at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxycodone consumption (time frame: 24h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.