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

NCT03078062 | Completed

• 1 other identifier: 16.374
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of a single-dose of intravenous dexamethasone 8 mg on the duration of sensory and motor blockade following spinal anesthesia with isobaric bupivacaine. The hypothesis of the study is that intravenous dexamethasone will significantly prolong (by more than 20 minutes) the duration of spinal anesthesia.

Conditions

Spinal Anesthesia; Prolonged Sensory Block; Prolonged Motor Block

Keywords

Spinal anesthesia; Motor block; Sensory block; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Regression of sensory block by 2 dermatomes

  Loss of pinprick sensation by Von Frey filaments from the injection of bupivacaine 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 2 hours after surgery

Secondary Outcomes (16)

• Duration of motor block

  At 5,10, 20 and 30 minutes following spinal anesthesia, then every 15 minutes until regression of 2 dermatomes and every 30 minutes thereafter until complete recovery, approximately 4 hours 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

• Surgeon's satisfaction towards spinal anesthesia

  At the end of surgery, on the day of randomization

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

During the performance of spinal anesthesia using isobaric 0.5% bupivacaine 12 mg, an intravenous infusion of dexamethasone 8 mg (2 ml) will be initiated. The study drug will be administered over 5 -10 minutes diluted in a 500 ml bag of Normal Saline for a total volume of 502 ml. The study drug will be prepared by an independent assistant.

Drug: Dexamethasone

Normal Saline

PLACEBO COMPARATOR

During the performance of spinal anesthesia using isobaric 0.5% bupivacaine 12 mg, an intravenous infusion of 502 ml of Normal Saline will be initiated. The infusion will be administered over 5 -10 minutes. The study drug will be prepared by an independent assistant.

Drug: Normal saline

Interventions

Dexamethasone DRUG

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

Also known as: Decadron

Dexamethasone

Normal saline DRUG

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

Also known as: Placebo

Normal Saline

Eligibility Criteria

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

You may qualify if:

• Patients undergoing lower body surgery under spinal anesthesia
• American Society of Anesthesiologists' physical status of 1 to 3

You may not qualify if:

• Contraindication to spinal anesthesia (coagulopathy, local infection at the site of injection)
• Pre-existing neuropathy or nerve block that could compromise study assessments
• Preoperative use of systemic corticosteroids
• Allergy or hypersensitivity to local anesthetics, dexamethasone or other drugs used in this study
• Patient refusal or inability to consent

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; Saline Solution

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; 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 R Williams, Md, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

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: March 3, 2017
• First Posted: March 13, 2017
• Study Start: May 26, 2017
• Primary Completion: October 26, 2017
• Study Completion: October 26, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)