Clinical trial NCT01811251: Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery
Official title: Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patients Undergoing a Lumbar Slipped Disc Surgery
Keywords: Co-analgesia
Dexamethasone
Pregabalin
Lumbar slipped disc surgery
Post-operative pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Pain
timeFrame: at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h
measure: Pain evaluated by ENS during the first mobilization at the edge of the bed
timeFrame: at J0+1 day
Secondary outcomes:
measure: Pain
timeFrame: during the first mobilization with standing up at J1
measure: Quality of the standing up (evaluated by Likert scale)
timeFrame: at J0+1day
measure: Patient satisfaction (evaluated by Likert scale)
timeFrame: at J0+1 day
measure: Consumption of morphine
timeFrame: between H0+2h and H0+24h
measure: Pain at rest
timeFrame: at J0+180 days
measure: assessment of neuropathic component DN4 scale
timeFrame: at J0+180 days
measure: statement of analgesic treatment
timeFrame: at J0+180 days
measure: Pain during mobilization
timeFrame: at J0+180 days
measure: Postoperative Nausea and Vomiting
timeFrame: at H0+24h
measure: Postoperative Nausea and Vomiting
timeFrame: at H0+48h
measure: Sedation
timeFrame: at J0 at the arrival in the operating room
measure: Sedation
timeFrame: at J0 at the end of SSPI
measure: Sedation
timeFrame: at H0+24 h
measure: Sedation
timeFrame: at H0+48h
measure: Existence of visual disturbances
timeFrame: at H0, between H0 and H0+48H
measure: Existence of lightheadedness
timeFrame: at H0, between H0 and H0+48H
measure: Existence of urinary retention
timeFrame: at H0, between H0 and H0+48H
measure: Existence of pruritus
timeFrame: at H0, between H0 and H0+48H
measure: Pain
timeFrame: at H0+0h30
measure: pain
timeFrame: at H0+1h
measure: pain
timeFrame: at H0+1h30
measure: pain
timeFrame: at H0+2h
measure: pain
timeFrame: at H0+6h
measure: pain
timeFrame: at H0+12h
measure: pain
timeFrame: at H0+24h
measure: pain
timeFrame: at H0+48h
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Bruno VERDIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.