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OpenTrials
Completed

NCT Number: NCT03527576

Block Duration After Spinal Block and iv Dexamethasone.

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.

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Key information

Conditions

Postoperative Pain Leg Injuries Lower Limb Injury Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.

NaCl 0.0308 MEQ/ML Injectable Solution

Drug

Intravenous injection of NaCl 0.9% before the surgery.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Eric Albrecht

Other

Registry information

Official study title

Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 17, 2018
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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