Patients Undergoing a Lumbar Slipped Disc SurgeryPhase 3DEXA-PG-HDNCT01811251
Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery
A Phase 3 study testing Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) in people with Patients Undergoing a Lumbar Slipped Disc Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients Undergoing a Lumbar Slipped Disc Surgery
- What is being tested?
- Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to 10 Oct 2017
- Phase
- Phase 3
- 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
Who may be able to join
- Patients undergoing a lumbar slipped disc surgery
- Aged 18 to 85 years.
- ASA score I-III
- Having given their consent.
- Affiliated with a social security scheme
Who cannot join
- Patients who must be operated urgently.
- Patients previously operated for lumbar spinal surgery.
- Expected duration of surgery more than 3 hours.
- Severe renal impairment defined by a creatinine clearance less than or equal to 30 mL/min.
- Taking long-term strong opiates .
- Taking long-term corticosteroids or within 48 hours before surgery.
Show all 14Show fewer
- Taking pregabalin or gabapentin within 48 hours before surgery.
- Drug addiction.
- Patients with cognitive impairment (judged by the investigator) that may interfere with:
- informed consent, the collection of endpoints, the use of auto-controlled analgesia.
- Pregnant or nursing women.
- Refusal of the protocol.
- Minor or major protected patients.
- Allergy or other cons-indication to the molecules used in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products.
Pain assessed by simple numerical scale will be also evaluated during the 48 first post-operative hours.
Determining an optimal co-analgesic protocol through the results of this study could help develop validation studies with larger scale such as a medico-economic component. In addition, these study protocols are easy to apply (ponctual administration) and inexpensive.
Read the detailed description
Visit 1 (J-30 J-1): pre-inclusion visit During a follow-up visit usual pathology, the doctor will propose to the patient to participate in the protocol. Information Form will be given to the patient to be read at home to maintain a sufficient time for reflection. Physician investigator check the eligibility criteria and complete a pre-screening form where he will note the following information about the patient: No pre-enrollment, name, date, reason for non-inclusion appropriate.
Visit 2 (J-1): pre-anesthetic visit, the day before surgery During the pre-anesthetic routine consultation, the doctor will check the proper collection of informed consent and then inform the following information on the CRF: randomization number, age, height, weight, ideal weight theory, gender patient.
Visit 3 (J0): surgery One hour before surgery, the patient will receive, according to randomization, premedication with pregabalin LYRICA ® or placebo orally.
Then the patient will be conducted in the operating room for induction of general anesthesia and surgery. Immediately after induction of anesthesia, depending on randomization, the patient will receive intravenous dexamethasone or placebo.
At the end of surgery, the patient is conducted in Post Anaesthesia Carry Unit (PACU) to be extubated and receive routine care after surgery.
Extubation of the patient, denoted H0 represents the time when the measurement begins.
The data collected from H0 are :
- ENS score standing at H0, H0+30mn, H0+1h, H0+1h30, H0+2 h, H0+6 h,H0+12 h, H0+24h, H0+48 h.
- ENS score mobilization at the first time the patient gets up (edge of the bed and standing if possible)
- Qualification of the quality of standing 0-4 (Likert scale (0 = very poor, 1 = poor, 2 = fair, 3 = good, 4 = very good)) by the nursing staff after the first mobilization
- Qualification of patient satisfaction compared to the first standing by a score of 0-4 (Likert scale (0 = very poor, 1 = poor, 2 = fair, 3 = good, 4 = very good))
- Sedation score at the end of SSPI, , at H0+24h and H0+48h
- Nausea and vomiting score at H0+24 h, H0+48 h
- Tolerance of the treatments undertaken : visual disturbances, lightheadedness, urinary retention, pruritus, measured at the end of SSPI at H0+24 h and H0+48 h
- Consumption of morphine at H0+24 h and H0+48 h
- Assessment of pain score at 6 months by score ENS at rest , assessment of neuropathic component by DN4 scale. Statement consumption of analgesic treatments.
- Being tested
- Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)
- Keywords
- Co-analgesia, Dexamethasone, Pregabalin, Lumbar slipped disc surgery, Post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)Drug
| Study group | Role | What they receive |
|---|---|---|
| Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) | Experimental | The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products Receives: Drug: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) |
| Lactose (150mg), NaC1 0.9% (50ml) | Placebo comparator | The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products Receives: Drug: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h
Pain evaluated by ENS during the first mobilization at the edge of the bed
Measured: at J0+1 day
Secondary outcomes (26)
Pain
Measured: during the first mobilization with standing up at J1
Quality of the standing up (evaluated by Likert scale)
Measured: at J0+1day
Patient satisfaction (evaluated by Likert scale)
Measured: at J0+1 day
Consumption of morphine
Measured: between H0+2h and H0+24h
Pain at rest
Measured: at J0+180 days
assessment of neuropathic component DN4 scale
Measured: at J0+180 days
statement of analgesic treatment
Measured: at J0+180 days
Pain during mobilization
Measured: at J0+180 days
Postoperative Nausea and Vomiting
Measured: at H0+24h
Postoperative Nausea and Vomiting
Measured: at H0+48h
Sedation
Measured: at J0 at the arrival in the operating room
Sedation
Measured: at J0 at the end of SSPI
Sedation
Measured: at H0+24 h
Sedation
Measured: at H0+48h
Existence of visual disturbances
Measured: at H0, between H0 and H0+48H
Existence of lightheadedness
Measured: at H0, between H0 and H0+48H
Existence of urinary retention
Measured: at H0, between H0 and H0+48H
Existence of pruritus
Measured: at H0, between H0 and H0+48H
Pain
Measured: at H0+0h30
pain
Measured: at H0+1h
pain
Measured: at H0+1h30
pain
Measured: at H0+2h
pain
Measured: at H0+6h
pain
Measured: at H0+12h
pain
Measured: at H0+24h
pain
Measured: at H0+48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startDec 2012
- Primary completion19 Sep 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing a Lumbar Slipped Disc SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno VERDIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811251
- Sponsor's protocol ID
- CHU-0132
- Other IDs
- 2012-003157-29
- Acronym
- DEXA-PG-HD
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2012
- Last updated
- 10 Aug 2026
- Results posted
- No
Publications
Momon A, Verdier B, Dolomie JO, Gardette M, Pereira B, Curt I, Duale C. A Single Preoperative Administration of Dexamethasone, Low-dose Pregabalin, or a Combination of the 2, in Spinal Surgery, Does Not Provide a Better Analgesia Than a Multimodal Analgesic Protocol Alone. Clin J Pain. 2019 Jul;35(7):594-601. doi: 10.1097/AJP.0000000000000719.
PubMed 31021886
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery
- ClinicalTrials.gov ID
- NCT01811251
- Acronym / sponsor ID
- DEXA-PG-HD / CHU-0132
- Keywords
- Co-analgesia, Dexamethasone, Pregabalin, Lumbar slipped disc surgery, Post-operative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 14 Mar 2013 (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.
The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products.
Pain assessed by simple numerical scale will be also evaluated during the 48 first post-operative hours.
Determining an optimal co-analgesic protocol through the results of this study could help develop validation studies with larger scale such as a medico-economic component. In addition, these study protocols are easy to apply (ponctual administration) and inexpensive.
Detailed description
Visit 1 (J-30 J-1): pre-inclusion visit During a follow-up visit usual pathology, the doctor will propose to the patient to participate in the protocol. Information Form will be given to the patient to be read at home to maintain a sufficient time for reflection. Physician investigator check the eligibility criteria and complete a pre-screening form where he will note the following information about the patient: No pre-enrollment, name, date, reason for non-inclusion appropriate.
Visit 2 (J-1): pre-anesthetic visit, the day before surgery During the pre-anesthetic routine consultation, the doctor will check the proper collection of informed consent and then inform the following information on the CRF: randomization number, age, height, weight, ideal weight theory, gender patient.
Visit 3 (J0): surgery One hour before surgery, the patient will receive, according to randomization, premedication with pregabalin LYRICA ® or placebo orally.
Then the patient will be conducted in the operating room for induction of general anesthesia and surgery. Immediately after induction of anesthesia, depending on randomization, the patient will receive intravenous dexamethasone or placebo.
At the end of surgery, the patient is conducted in Post Anaesthesia Carry Unit (PACU) to be extubated and receive routine care after surgery.
Extubation of the patient, denoted H0 represents the time when the measurement begins.
The data collected from H0 are :
- ENS score standing at H0, H0+30mn, H0+1h, H0+1h30, H0+2 h, H0+6 h,H0+12 h, H0+24h, H0+48 h.
- ENS score mobilization at the first time the patient gets up (edge of the bed and standing if possible)
- Qualification of the quality of standing 0-4 (Likert scale (0 = very poor, 1 = poor, 2 = fair, 3 = good, 4 = very good)) by the nursing staff after the first mobilization
- Qualification of patient satisfaction compared to the first standing by a score of 0-4 (Likert scale (0 = very poor, 1 = poor, 2 = fair, 3 = good, 4 = very good))
- Sedation score at the end of SSPI, , at H0+24h and H0+48h
- Nausea and vomiting score at H0+24 h, H0+48 h
- Tolerance of the treatments undertaken : visual disturbances, lightheadedness, urinary retention, pruritus, measured at the end of SSPI at H0+24 h and H0+48 h
- Consumption of morphine at H0+24 h and H0+48 h
- Assessment of pain score at 6 months by score ENS at rest , assessment of neuropathic component by DN4 scale. Statement consumption of analgesic treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) | Experimental | Drug: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products |
| Lactose (150mg), NaC1 0.9% (50ml) | Placebo comparator | Drug: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing a lumbar slipped disc surgery
- Aged 18 to 85 years.
- ASA score I-III
- Having given their consent.
- Affiliated with a social security scheme
Key exclusion criteria (14 listed)
- Patients who must be operated urgently.
- Patients previously operated for lumbar spinal surgery.
- Expected duration of surgery more than 3 hours.
- Severe renal impairment defined by a creatinine clearance less than or equal to 30 mL/min.
- Taking long-term strong opiates .
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 |
|---|---|---|
| Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) | Drug | Lactose (150mg), NaC1 0.9% (50ml), Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) |
Primary outcome
Pain
Time frame: at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h
Pain evaluated by ENS during the first mobilization at the edge of the bed
Time frame: at J0+1 day
26 secondary outcomes
Pain
Time frame: during the first mobilization with standing up at J1
Quality of the standing up (evaluated by Likert scale)
Time frame: at J0+1day
Patient satisfaction (evaluated by Likert scale)
Time frame: at J0+1 day
Consumption of morphine
Time frame: between H0+2h and H0+24h
Pain at rest
Time frame: at J0+180 days
assessment of neuropathic component DN4 scale
Time frame: at J0+180 days
statement of analgesic treatment
Time frame: at J0+180 days
Pain during mobilization
Time frame: at J0+180 days
Postoperative Nausea and Vomiting
Time frame: at H0+24h
Postoperative Nausea and Vomiting
Time frame: at H0+48h
Sedation
Time frame: at J0 at the arrival in the operating room
Sedation
Time frame: at J0 at the end of SSPI
Sedation
Time frame: at H0+24 h
Sedation
Time frame: at H0+48h
Existence of visual disturbances
Time frame: at H0, between H0 and H0+48H
Existence of lightheadedness
Time frame: at H0, between H0 and H0+48H
Existence of urinary retention
Time frame: at H0, between H0 and H0+48H
Existence of pruritus
Time frame: at H0, between H0 and H0+48H
Pain
Time frame: at H0+0h30
pain
Time frame: at H0+1h
pain
Time frame: at H0+1h30
pain
Time frame: at H0+2h
pain
Time frame: at H0+6h
pain
Time frame: at H0+12h
pain
Time frame: at H0+24h
pain
Time frame: at H0+48h
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 10 Aug 2026.
- Background: PubMed 31021886Momon A, Verdier B, Dolomie JO, Gardette M, Pereira B, Curt I, Duale C. A Single Preoperative Administration of Dexamethasone, Low-dose Pregabalin, or a Combination of the 2, in Spinal Surgery, Does Not Provide a Better Analgesia Than a Multimodal Analgesic Protocol Alone. Clin J Pain. 2019 Jul;35(7):594-601. doi: 10.1097/AJP.0000000000000719.
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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.
Bruno VERDIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) in people with Patients Undergoing a Lumbar Slipped Disc Surgery, run by University Hospital, Clermont-Ferrand 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 14 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 10 Aug 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain (time frame: at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01811251, which also lists 1 linked publication.
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 10 Aug 2026.