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

NCT07837674 | Not Yet Recruiting

• 1 other identifier: 2027-13916
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Anesthesia; Prolonged Sensory Block; Prolonged Motor Block

Keywords

Dexamethasone; Chloroprocaine

Outcome Measures

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

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

Secondary Outcomes (20)

• Duration of motor block

  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

  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

  Up to 30 minutes following spinal anesthesia

• Onset of motor block

  Up to 30 minutes following spinal anesthesia

• Quality of motor block

  Up to 30 minutes following spinal anesthesia

Study Arms (2)

Intravenous dexamethasone

ACTIVE COMPARATOR

During the performance of spinal anesthesia using isobaric 1% chloroprocaine 50 mg, an intravenous infusion of dexamethasone 8 mg (2 ml) will be initiated. The study drug will be administered intravenously over one minute. The study drug will be prepared by an independent assistant.

Drug: Intravenous Dexamethasone

Intravenous normal saline

PLACEBO COMPARATOR

During the performance of spinal anesthesia using isobaric 1% chloroprocaine 50 mg, an intravenous infusion of 2 ml of Normal Saline will be initiated. The normal saline will be administered intravenously over one minute. The study drug will be prepared by an independent assistant.

Drug: Normal Saline

Interventions

Normal Saline DRUG

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

Also known as: Placebo

Intravenous normal saline

Intravenous Dexamethasone DRUG

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

Also known as: Decadron

Intravenous dexamethasone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Santé Québec - Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Interventions

Calcium Dobesilate; Saline Solution

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Stephan Williams, MD, PhD

  Santé Québec - CHUM

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients in both groups will receive the study drug (dexamethasone or placebo) in the same volume of normal saline. The study drug will be prepared by an independent assistant.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CA (1)