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CompletedNCT03527576Updated Jul 20, 2022

Block Duration After Spinal Block and iv Dexamethasone.

A Phase 4 interventional study of Dexamethasone and NaCl 0.0308 MEQ/ML Injectable Solution in Postoperative Pain and Lower Limb Injury, sponsored by Eric Albrecht. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Eric Albrecht · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Pain
  • Lower Limb Injury

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Polytrauma patient
  • Pregnancy
  • Contraindication to spinal anesthesia
  • Contraindication to dexamethasone administration
  • Patient with chronic pain
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Dexamethasone

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

    Drug: Dexamethasone

  • Placebo comparator
    Placebo

    Intravenous injection of NaCl 0,9% before the surgery.

    Drug: NaCl 0.0308 MEQ/ML Injectable Solution

Interventions

  • DrugDexamethasone

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

  • DrugNaCl 0.0308 MEQ/ML Injectable Solution

    Intravenous injection of NaCl 0.9% before the surgery.

05

What researchers measure

Primary outcomes

  1. Duration of sensory block (minutes)

    Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached

    Time frame: Postoperative day 0

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

    Numeric rating scale (0-10)

    Time frame: Postoperative days 0, 1 and 2

  8. Rate of postoperative nausea and vomiting

    YES/NO

    Time frame: Postoperative day 0, 1 and 2

  9. Rate of pruritus

    YES/NO

    Time frame: Postoperative day 0, 1 and 2

  10. Rate of urinary retention

    YES/NO

    Time frame: Postoperative day 1 and 2

  11. Satisfaction level

    Numeric rating scale (0-10)

    Time frame: Postoperative day 2

  12. Length of stay

    Days

    Time frame: up to 14 days

  13. Persistent pain

    YES/NO

    Time frame: 3 and 6 postoperative months

  14. Pain score if persistent pain

    Numeric rating scale (0-10)

    Time frame: 3 and 6 postoperative months

06

Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois and University of Lausanne
    Lausanne, Vaud 1011, Switzerland
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03527576
Lead sponsor
Eric Albrecht
Responsible party
Eric Albrecht (Program director of regional anaesthesia, Centre Hospitalier Universitaire Vaudois) — Sponsor-investigator
First posted
May 17, 2018
Start date
May 1, 2018
Primary completion
Nov 1, 2021
Completion
Apr 1, 2022
Last update
Jul 20, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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