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

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ClinicalTrials.gov Identifier: NCT03078062
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.


Condition or disease Intervention/treatment Phase
Spinal Anesthesia Prolonged Sensory Block Prolonged Motor Block Drug: Dexamethasone Drug: Normal saline Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, double-blind, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
Official Title: Impact of Intravenous Dexamethasone on the Duration of Sensory and Motor Block Following a Bupivacaine-based Spinal Anesthesia
Actual Study Start Date : May 26, 2017
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexamethasone
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
Administration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia
Other Name: Decadron

Placebo Comparator: Normal Saline
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
Administration of a single-dose of Normal saline during spinal anesthesia
Other Name: Placebo




Primary Outcome Measures :
  1. Regression of sensory block by 2 dermatomes [ Time Frame: At regression of spinal anesthesia by 2 dermatomes, approximately 2 hours after surgery ]
    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


Secondary Outcome Measures :
  1. Duration of motor block [ Time Frame: 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 ]
    Using the Bromage scale from the time of injection of bupivacaine for spinal anesthesia until complete recovery of motor block

  2. Onset of sensory block [ Time Frame: Up to 30 minutes following spinal anesthesia ]
    Time from injection of bupivacaine for spinal anesthesia to reduction of sensitivity using loss of pinprick sensation

  3. Onset of motor block [ Time Frame: Up to 30 minutes following spinal anesthesia ]
    Time from injection of bupivacaine for spinal anesthesia to reduction of lower limbs movement using the Bromage scale

  4. Quality of motor block [ Time Frame: Up to 30 minutes following spinal anesthesia ]
    Maximal Bromage score

  5. Surgeon's satisfaction towards spinal anesthesia [ Time Frame: At the end of surgery, on the day of randomization ]
    Unsatisfied or satisfied

  6. Time to first analgesic request [ Time Frame: From the end of surgery up to approximately six hours after surgery, on the day of randomization ]
    First request by the patient for an analgesic or pain superior to 3 on a scale from 0 to 10; where 0 means "no pain at all" and 10 means "worst pain imaginable"

  7. Opioid consumption [ Time Frame: At recovery room discharge, approximately one hour after the end of surgery on the day of randomization and 24 hours following surgery ]
    Total dose of opioids

  8. Incidence of hypotension [ Time Frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery ]
    Systolic blood pressure lower than 90 mm Hg

  9. Incidence of bradycardia [ Time Frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery ]
    Heart rate slower than 50 beats per minute

  10. Incidence of nausea [ Time Frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery ]
    Any episode of nausea reported by the patient or nursing team

  11. Incidence of vomiting [ Time Frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery ]
    Any episode of retching or vomiting reported by the patient or nursing team

  12. Incidence of urinary retention [ Time Frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery ]
    Any episode of urinary retention reported by the patient or nursing team

  13. Incidence of shivering [ Time Frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery ]
    Any episode of shivering reported by the patient or nursing team

  14. Incidence of headache [ Time Frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery ]
    Any episode of headache reported by the patient or nursing team

  15. Quality of sleep [ Time Frame: At 24 hours after surgery ]
    Described by the patient as good or bad

  16. Duration of sensory block [ Time Frame: At 5,10, 20 and 30 minutes following spinal anesthesia, then every 15 minutes until regression by 2 dermatomes and every 30 minutes thereafter until complete recovery, approximately 4 hours after surgery ]
    Loss of pinprick sensation by Von Frey filaments from the injection of bupivacaine for spinal anesthesia until complete recovery



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078062


Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Stephan R Williams, Md, PhD Centre hospitalier de l'Université de Montréal (CHUM)

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03078062     History of Changes
Other Study ID Numbers: 16.374
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Spinal anesthesia
Motor block
Sensory block
Dexamethasone

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Dexamethasone acetate
Dexamethasone
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Sensory System Agents