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

N/ANot Yet RecruitingNCT07837674

Centre hospitalier de l'Université de Montréal (CHUM)60 enrolled

Overview

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.

Spinal anesthesia is commonly used for lower body surgery. The injection of local anesthetics in the lumbar intrathecal space allows the desensitization of the lower body by blocking sensory and motor nerve roots. In return, spinal anesthesia causes a sympathetic block which is associated with deleterious hemodynamic effects such as hypotension. Isobaric chloroprocaine is a local anesthetic increasingly used for spinal anesthesia to reduce the duration of sensory and motor blocks compared to bupivacaine, allowing for faster postoperative recovery. However, certain medications used during surgery may possibly influence the duration of spinal anesthesia. Among these is dexamethasone, a drug belonging to the corticosteroid family. Dexamethasone is a well-known and commonly used medication in anesthesia to prevent postoperative nausea and vomiting. It is also used by anesthesiologists to reduce pain in the context of fast functional recovery after surgery. The safety of single-dose intravenous dexamethasone is therefore established in the context of anesthesia for several types of surgery. Medical literature demonstrates that dexamethasone can prolong the effect of certain local anesthetics when administered intravenously or perineurally (near the nerves), and sometimes has no effect on the duration of local anesthetics administered for spinal anesthesia. Currently, no information is available in the literature on the effect of intravenous dexamethasone on the duration of a spinal anesthesia with isobaric chloroprocaine. This study aims 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Spinal Anesthesia Prolonged Sensory Block Prolonged Motor Block

Interventions

Intravenous DexamethasoneDRUG

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

Normal SalineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patient refusal * Inability to consent * Language barrier, psychiatric, physical, or mental condition making sensory and motor blocks assessment impossible despite prior instruction * Administration of any intrathecal adjuvant (fentanyl, morphine, clonidine, dexmedetomidine, epinephrine, or others) along with chloroprocaine * Perioperative intravenous dexmedetomidine administration * Conversion to general anesthesia * Impossible post-anesthesia care unit assessment: patient still intubated / transfer to intensive care unit, research team constraints, or other reasons * Assessment in the recovery room impossible: medical condition (shock, delirium, major agitation, altered state of consciousness, or other), transfer to the intensive care unit, research team constraints, or other

Locations (1)

Santé Québec - Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

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

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

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

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

Quality of motor block

Maximal Bromage score

Time frame: Up to 30 minutes following spinal anesthesia

Central Contacts

Stephan Williams, MD, PhD

CONTACT

514-890-8000 stephan.williams@umontreal.ca

Julie Desroches, PhD

CONTACT

514-890-8000 anesthesie.recherche.chum@ssss.gouv.qc.ca

Data from ClinicalTrials.gov

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