Block Duration After Spinal Block and iv Dexamethasone.

Study Overview
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Brief Summary
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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.

Official Title
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Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial

Conditions
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Postoperative Pain, Lower Limb Injury

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: NaCl 0.0308 MEQ/ML Injectable Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery. | Drug: Dexamethasone<br>* Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.<br>|
| Placebo Comparator: Placebo<br>Intravenous injection of NaCl 0,9% before the surgery. | Drug: NaCl 0.0308 MEQ/ML Injectable Solution<br>* Intravenous injection of NaCl 0.9% before the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Cumulative consumption of morphine (mg) |  | Postoperative days 0, 1 and 2 | 
| Pain score | Numeric rating scale (0-10) | Postoperative days 0, 1 and 2 | 
| Rate of postoperative nausea and vomiting | YES/NO | Postoperative day 0, 1 and 2 | 
| Rate of pruritus | YES/NO | Postoperative day 0, 1 and 2 | 
| Rate of urinary retention | YES/NO | Postoperative day 1 and 2 | 
| Satisfaction level | Numeric rating scale (0-10) | Postoperative day 2 | 
| Length of stay | Days | up to 14 days | 
| Persistent pain | YES/NO | 3 and 6 postoperative months | 
| Pain score if persistent pain | Numeric rating scale (0-10) | 3 and 6 postoperative months |