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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03527576
Other study ID # CER 2018-00500
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 1, 2018
Est. completion date April 1, 2022

Study information

Verified date July 2022
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 1, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
NaCl 0.0308 MEQ/ML Injectable Solution
Intravenous injection of NaCl 0.9% before the surgery.

Locations

Country Name City State
Switzerland Centre Hospitalier Universitaire Vaudois and University of Lausanne Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Eric Albrecht

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Postoperative day 0
Secondary Highest dermatoma reached (level) Postoperative day 0
Secondary Onset time between injection and highest dermatoma (minutes) Postoperative day 0
Secondary Total duration of the sensory block (minutes) Postoperative day 0
Secondary Total duration of the motor block (minutes) Postoperative day 0
Secondary Time to the first analgesic request (minutes) Postoperative day 0
Secondary Cumulative consumption of morphine (mg) Postoperative days 0, 1 and 2
Secondary Pain score Numeric rating scale (0-10) Postoperative days 0, 1 and 2
Secondary Rate of postoperative nausea and vomiting YES/NO Postoperative day 0, 1 and 2
Secondary Rate of pruritus YES/NO Postoperative day 0, 1 and 2
Secondary Rate of urinary retention YES/NO Postoperative day 1 and 2
Secondary Satisfaction level Numeric rating scale (0-10) Postoperative day 2
Secondary Length of stay Days up to 14 days
Secondary Persistent pain YES/NO 3 and 6 postoperative months
Secondary Pain score if persistent pain Numeric rating scale (0-10) 3 and 6 postoperative months
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