Impact of Intravenous Dexamethasone on the Duration of Motor and Sensory Block Following Spinal Anesthesia With Chloroprocaine

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

The purpose of this study is to compare the effect of a single dose of 8 mg of intravenous dexamethasone versus placebo on the duration of sensory and motor block after spinal anesthesia with chloroprocaine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 90 years old

ASA status I to III inclusively

Planned lower body surgery under spinal anesthesia with chloroprocaine

Signed informed consent form

Disqualifiers

Contraindication to spinal anesthesia: infection at the puncture site, congenital or acquired coagulopathy

Preexisting neuropathy or nerve block that could interfere with study assessments

Allergy or hypersensitivity to local anesthetics, dexamethasone, or other medications used in the study

Preoperative use of corticosteroids

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous Dexamethasone

    Drug

    Administration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia with chloprocaine

  • Normal Saline

    Drug

    Administration of a single-dose of Normal saline during spinal anesthesia with chloprocaine

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intravenous dexamethasoneActive comparator 1 intervention
Group B: Intravenous normal salinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Regression of sensory block by 2 dermatomes

Loss of pinprick sensation by Von Frey filaments from the injection of chloroprocaine for spinal anesthesia until regression of the sensory block by two dermatomes from the peak sensory level

Time frame
At regression of spinal anesthesia by 2 dermatomes, approximately 60 minutes after surgery

Secondary outcomes

1

Duration of motor block

Using the Bromage scale from the time of injection of chloroprocaine for spinal anesthesia until complete recovery of motor block

Time frame
At 5,10,15 and 20 minutes following spinal anesthesia, then every 10 minutes until complete recovery, approximately 90 minutes after surgery
2

Time until the first observable regression of the motor block

Time between the local anesthesic injection and the first measurable regression of the motor block measured using the Bromage scale.

Time frame
At 5,10,15 and 20 minutes following spinal anesthesia, then every 10 minutes until complete recovery, approximately 90 minutes after surgery
3

Onset of sensory block

Time from injection of chloroprocaine for spinal anesthesia to reduction of sensitivity using loss of pinprick sensation

Time frame
Up to 30 minutes following spinal anesthesia
4

Onset of motor block

Time from injection of chloroprocaine for spinal anesthesia to reduction of lower limbs movement using the Bromage scale

Time frame
Up to 30 minutes following spinal anesthesia

Other outcomes

Sponsors and contacts

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