Block Duration After Spinal Block and iv Dexamethasone.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2022-04-01

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.

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Detailed Description

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Conditions

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Postoperative Pain Lower Limb Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dexamethasone

Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.

Placebo

Intravenous injection of NaCl 0,9% before the surgery.

Group Type PLACEBO_COMPARATOR

NaCl 0.0308 MEQ/ML Injectable Solution

Intervention Type DRUG

Intravenous injection of NaCl 0.9% before the surgery.

Interventions

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Dexamethasone

Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.

Intervention Type DRUG

NaCl 0.0308 MEQ/ML Injectable Solution

Intravenous injection of NaCl 0.9% before the surgery.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No