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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01811251
First received: December 4, 2012
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Patients Undergoing a Lumbar Slipped Disc Surgery
Drug: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Pain [ Time Frame: at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h ] [ Designated as safety issue: Yes ]
  • Pain evaluated by ENS during the first mobilization at the edge of the bed [ Time Frame: at J0+1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: during the first mobilization with standing up at J1 ] [ Designated as safety issue: Yes ]
  • Quality of the standing up (evaluated by Likert scale) [ Time Frame: at J0+1day ] [ Designated as safety issue: No ]
  • Patient satisfaction (evaluated by Likert scale) [ Time Frame: at J0+1 day ] [ Designated as safety issue: No ]
  • Consumption of morphine [ Time Frame: between H0+2h and H0+24h ] [ Designated as safety issue: Yes ]
  • Pain at rest [ Time Frame: at J0+180 days ] [ Designated as safety issue: Yes ]
  • assessment of neuropathic component DN4 scale [ Time Frame: at J0+180 days ] [ Designated as safety issue: Yes ]
  • statement of analgesic treatment [ Time Frame: at J0+180 days ] [ Designated as safety issue: No ]
  • Pain during mobilization [ Time Frame: at J0+180 days ] [ Designated as safety issue: Yes ]
  • Postoperative Nausea and Vomiting [ Time Frame: at H0+24h ] [ Designated as safety issue: Yes ]
  • Postoperative Nausea and Vomiting [ Time Frame: at H0+48h ] [ Designated as safety issue: Yes ]
  • Sedation [ Time Frame: at J0 at the arrival in the operating room ] [ Designated as safety issue: Yes ]
  • Sedation [ Time Frame: at J0 at the end of SSPI ] [ Designated as safety issue: Yes ]
  • Sedation [ Time Frame: at H0+24 h ] [ Designated as safety issue: No ]
  • Sedation [ Time Frame: at H0+48h ] [ Designated as safety issue: Yes ]
  • Existence of visual disturbances [ Time Frame: at H0, between H0 and H0+48H ] [ Designated as safety issue: Yes ]
  • Existence of lightheadedness [ Time Frame: at H0, between H0 and H0+48H ] [ Designated as safety issue: Yes ]
  • Existence of urinary retention [ Time Frame: at H0, between H0 and H0+48H ] [ Designated as safety issue: Yes ]
  • Existence of pruritus [ Time Frame: at H0, between H0 and H0+48H ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
  • 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 and at mobilization, assessment of neuropathic component by DN4 scale. Statement consumption of analgesic treatments.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 opioid analgesics.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811251

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Bruno VERDIER University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01811251     History of Changes
Other Study ID Numbers: CHU-0132, 2012-003157-29
Study First Received: December 4, 2012
Last Updated: March 12, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Co-analgesia
Dexamethasone
Pregabalin
Lumbar slipped disc surgery
Post-operative pain

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Bone Diseases
Hernia
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases
Analgesics
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Pregabalin
Anti-Inflammatory Agents
Anticonvulsants
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014