Block Duration After Spinal Block and iv Dexamethasone.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 postoperative-pain
Started May 2018
Longer than P75 for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 4, 2018
CompletedFirst Posted
Study publicly available on registry
May 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJuly 20, 2022
July 1, 2022
3.5 years
May 4, 2018
July 19, 2022
Conditions
Outcome Measures
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
Postoperative day 0
Secondary Outcomes (14)
Highest dermatoma reached (level)
Postoperative day 0
Onset time between injection and highest dermatoma (minutes)
Postoperative day 0
Total duration of the sensory block (minutes)
Postoperative day 0
Total duration of the motor block (minutes)
Postoperative day 0
Time to the first analgesic request (minutes)
Postoperative day 0
- +9 more secondary outcomes
Study Arms (2)
Dexamethasone
ACTIVE COMPARATORIntravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
Placebo
PLACEBO COMPARATORIntravenous injection of NaCl 0,9% before the surgery.
Interventions
Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
Intravenous injection of NaCl 0.9% before the surgery.
Eligibility Criteria
You may qualify if:
- Patient with ASA I-III status ;
- Patient scheduled for an osteosynthesis surgy of the lower limb
You may not qualify if:
- Polytrauma patient
- Pregnancy
- Contraindication to spinal anesthesia
- Contraindication to dexamethasone administration
- Patient with chronic pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eric Albrechtlead
Study Sites (1)
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011, Switzerland
Related Publications (1)
Bikfalvi A, Hofmann G, Bashawyah A, Rossel JB, Gonvers E, Albrecht E. Sensory block duration after spinal anaesthesia supplemented with intravenous dexamethasone: a randomised controlled double-blinded trial. Br J Anaesth. 2023 Jun;130(6):780-785. doi: 10.1016/j.bja.2023.02.027. Epub 2023 Mar 23.
PMID: 36966023DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Program director of regional anaesthesia
Study Record Dates
First Submitted
May 4, 2018
First Posted
May 17, 2018
Study Start
May 1, 2018
Primary Completion
November 1, 2021
Study Completion
April 1, 2022
Last Updated
July 20, 2022
Record last verified: 2022-07