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Block Duration After Spinal Block and iv Dexamethasone.

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ClinicalTrials.gov Identifier: NCT03527576
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Brief Summary:
It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia after peripheral nerve block. However, data are missing regarding the duration of analgesia after spinal block. The objective of this randomized controlled double-blinded trial is to assess whether intravenous dexamethasone administered after a spinal block, before the surgery would prolong sensory block characteristics without impacting the motor block duration.

Condition or disease Intervention/treatment Phase
Postoperative Pain Lower Limb Injury Drug: Dexamethasone Drug: NaCl 0.0308 MEQ/ML Injectable Solution Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexamethasone
Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
Drug: Dexamethasone
Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.

Placebo Comparator: Placebo
Intravenous injection of NaCl 0,9% before the surgery.
Drug: NaCl 0.0308 MEQ/ML Injectable Solution
Intravenous injection of NaCl 0.9% before the surgery.




Primary Outcome Measures :
  1. Duration of sensory block (minutes) [ Time Frame: Postoperative day 0 ]
    Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached


Secondary Outcome Measures :
  1. Highest dermatoma reached (level) [ Time Frame: Postoperative day 0 ]
  2. Onset time between injection and highest dermatoma (minutes) [ Time Frame: Postoperative day 0 ]
  3. Total duration of the sensory block (minutes) [ Time Frame: Postoperative day 0 ]
  4. Total duration of the motor block (minutes) [ Time Frame: Postoperative day 0 ]
  5. Time to the first analgesic request (minutes) [ Time Frame: Postoperative day 0 ]
  6. Cumulative consumption of morphine (mg) [ Time Frame: Postoperative days 0, 1 and 2 ]
  7. Pain score [ Time Frame: Postoperative days 0, 1 and 2 ]
    Numeric rating scale (0-10)

  8. Rate of postoperative nausea and vomiting [ Time Frame: Postoperative day 0, 1 and 2 ]
    YES/NO

  9. Rate of pruritus [ Time Frame: Postoperative day 0, 1 and 2 ]
    YES/NO

  10. Rate of urinary retention [ Time Frame: Postoperative day 1 and 2 ]
    YES/NO

  11. Satisfaction level [ Time Frame: Postoperative day 2 ]
    Numeric rating scale (0-10)

  12. Length of stay [ Time Frame: up to 14 days ]
    Days

  13. Persistent pain [ Time Frame: 3 and 6 postoperative months ]
    YES/NO

  14. Pain score if persistent pain [ Time Frame: 3 and 6 postoperative months ]
    Numeric rating scale (0-10)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with ASA I-III status ;
  • Patient scheduled for an osteosynthesis surgy of the lower limb

Exclusion Criteria:

  • Polytrauma patient
  • Pregnancy
  • Contraindication to spinal anesthesia
  • Contraindication to dexamethasone administration
  • Patient with chronic pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527576


Contacts
Contact: Eric Albrecht, PD Dr +41 79 556 63 41 eric.albrecht@chuv.ch
Contact: Jonathan Frauenknecht +41 78 960 51 86 jonfrauen@bluewin.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois and University of Lausanne Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Eric Albrecht, PD Dr    +41795566341    eric.albrecht@chuv.ch   
Sponsors and Collaborators
Eric Albrecht

Responsible Party: Eric Albrecht, Program director of regional anaesthesia, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03527576     History of Changes
Other Study ID Numbers: CER 2018-00500
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Pain, Postoperative
Leg Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Wounds and Injuries
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action