Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery (DEXA-PG-HD)

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.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing a Lumbar Slipped Disc Surgery
• Intervention / Treatment: Drug: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)

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 Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)
PLACEBO_COMPARATOR: Lactose (150mg), NaC1 0.9% (50ml); 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	Drug: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain	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	at J0+1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Bruno VERDIER, University Hospital, Clermont-Ferrand

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2012
• Primary Completion (ACTUAL): September 19, 2017
• Study Completion (ACTUAL): October 10, 2017

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (ESTIMATE): March 14, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Dexamethasone; Post-operative pain; Pregabalin; Co-analgesia; Lumbar slipped disc surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Dexamethasone; Pregabalin
• Other Study ID Numbers: CHU-0132; 2012-003157-29