Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery

Patients Undergoing a Lumbar Slipped Disc Surgery Clinical Trial

— DEXA-PG-HD  

Official title:

Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811251
• Other study ID #: CHU-0132
• Secondary ID: 2012-003157-29
• Status: Completed
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: October 10, 2017

Study information

• Verified date: November 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 10, 2017
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Patients Undergoing a Lumbar Slipped Disc Surgery

Intervention

Drug:
• Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (1)

Momon A, Verdier B, Dolomie JO, Gardette M, Pereira B, Curt I, Dualé C. A Single Preoperative Administration of Dexamethasone, Low-dose Pregabalin, or a Combination of the Two, in Spinal Surgery does not Provide a Better Analgesia than a Multimodal Analgesic Protocol Alone. Clin J Pain. 2019 Apr 23. doi: 10.1097/AJP.0000000000000719. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h
Primary	Pain evaluated by ENS during the first mobilization at the edge of the bed		at J0+1 day
Secondary	Pain		during the first mobilization with standing up at J1
Secondary	Quality of the standing up (evaluated by Likert scale)		at J0+1day
Secondary	Patient satisfaction (evaluated by Likert scale)		at J0+1 day
Secondary	Consumption of morphine		between H0+2h and H0+24h
Secondary	Pain at rest		at J0+180 days
Secondary	assessment of neuropathic component DN4 scale		at J0+180 days
Secondary	statement of analgesic treatment		at J0+180 days
Secondary	Pain during mobilization		at J0+180 days
Secondary	Postoperative Nausea and Vomiting		at H0+24h
Secondary	Postoperative Nausea and Vomiting		at H0+48h
Secondary	Sedation		at J0 at the arrival in the operating room
Secondary	Sedation		at J0 at the end of SSPI
Secondary	Sedation		at H0+24 h
Secondary	Sedation		at H0+48h
Secondary	Existence of visual disturbances		at H0, between H0 and H0+48H
Secondary	Existence of lightheadedness		at H0, between H0 and H0+48H
Secondary	Existence of urinary retention		at H0, between H0 and H0+48H
Secondary	Existence of pruritus		at H0, between H0 and H0+48H
Secondary	Pain		at H0+0h30
Secondary	pain		at H0+1h
Secondary	pain		at H0+1h30
Secondary	pain		at H0+2h
Secondary	pain		at H0+6h
Secondary	pain		at H0+12h
Secondary	pain		at H0+24h
Secondary	pain		at H0+48h