ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 148 studies testing dexamethasone in Pain, Postoperative — 27 open to participants now, 30 under way, 2 of them phase 3. Dexamethasone · Pain, Postoperative.

Enrollment
123rd of 148
50 · median 89
Started
2018
with 9 others
Phase 4
75 of 148
14 open now
Registered
52nd of 148
by date

Among the 148 studies testing dexamethasone in Pain, Postoperative, this one is the 123rd largest by enrollment, is one of 10 that started in 2018, is one of 75 in phase 4, and was the 52nd registered.

By phase

148 studies; the count open now beside each. This study's row is marked.

Phase 4this study75 · 14 open
No phase37 · 6 open
Phase 316 · 2 open
Phase 16 · 3 open
Phase 26 · 0 open
Phase 1/25 · 2 open
Phase 2/33 · 0 open

By the year they started

First in 2005; this study’s year is marked. 10 started in 2018.

Size and results

Median enrollment 89 across the 148 interventional studies. Of the 96 that completed or were terminated, 22 (23%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 148 studies testing dexamethasone in Pain, Postoperative, or all of them as a file.
02

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.

03

Conditions studied

  • Postoperative Pain
  • Lower Limb Injury
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with status ;
  • Patient scheduled for an osteosynthesis surgy of the lower limb

Exclusion criteria

Exclusion Criteria:

  • Polytrauma patient
  • Pregnancy
  • to spinal anesthesia
  • Contraindication to dexamethasone administration
  • Patient with chronic pain
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

  • 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.

06

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

07

Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois and University of Lausanne
    Lausanne, Vaud 1011, Switzerland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Nov 2021, 42 months.

Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's 42 months is above that.

Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2018
First posted
May 17, 2018
StartActual
May 1, 2018
Primary completionActual
Nov 1, 2021
CompletionActual
Apr 1, 2022
Last update
Jul 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexamethasone

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