Lower Limb Injury, Postoperative Pain
Conditions
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.
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.
Sponsors
Eric Albrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of sensory block (minutes) | Postoperative day 0 | Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score if persistent pain | 3 and 6 postoperative months | Numeric rating scale (0-10) |
| 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 | — |
| Persistent pain | 3 and 6 postoperative months | YES/NO |
| Pain score | Postoperative days 0, 1 and 2 | Numeric rating scale (0-10) |
| Rate of postoperative nausea and vomiting | Postoperative day 0, 1 and 2 | YES/NO |
| Rate of pruritus | Postoperative day 0, 1 and 2 | YES/NO |
| Rate of urinary retention | Postoperative day 1 and 2 | YES/NO |
| Satisfaction level | Postoperative day 2 | Numeric rating scale (0-10) |
| Length of stay | up to 14 days | Days |
| Cumulative consumption of morphine (mg) | Postoperative days 0, 1 and 2 | — |
Countries
Switzerland
Outcome results
None listed