Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07837674

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santé Québec - Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location contact

Julie Desroches, PhD

CONTACT

[email protected]

514-890-8000 ext. 24542

Stephan Williams, MD, PhD

CONTACT

[email protected]

514-890-8000 ext. 12132

Stephan Williams, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous dexamethasone

Drug

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

Other names: Decadron

normal saline

Drug

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

Other names: Placebo

Primary outcomes

  1. Regression of sensory block by 2 dermatomes

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

    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

Secondary outcomes

  1. Duration 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

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

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

  3. Onset of sensory block

    Time frame: Up to 30 minutes following spinal anesthesia

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

  4. Onset of motor block

    Time frame: Up to 30 minutes following spinal anesthesia

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

  5. Quality of motor block

    Time frame: Up to 30 minutes following spinal anesthesia

    Maximal Bromage score

  6. Opioid consumption

    Time frame: At recovery room discharge, approximately one hour after the end of surgery

    Total dose of opioids

  7. Antiemetic consumption

    Time frame: At recovery room discharge, approximately one hour after the end of surgery

    Total dose of antiemetics

  8. Incidence of hypotension

    Time frame: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery

    Systolic blood pressure lower than 90 mm Hg

  9. Incidence of bradycardia

    Time frame: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery

    Heart rate slower than 50 beats per minute

  10. Incidence of nausea

    Time frame: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery

    Any episode of nausea reported by the patient or nursing team

  11. Incidence of vomiting

    Time frame: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery

    Any episode of retching or vomiting reported by the patient or nursing team

  12. Incidence of itching

    Time frame: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery

    Any episode of itching reported by the patient or nursing team

  13. Incidence of urinary retention

    Time frame: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery

    Any episode of urinary retention reported by the patient or nursing team

  14. Incidence of shivering

    Time frame: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery

    Any episode of shivering reported by the patient or nursing team

  15. Incidence of headache

    Time frame: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery

    Any episode of headache reported by the patient or nursing team

  16. Quality of postoperative recovery

    Time frame: At 24 hours after the surgery

    QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score), giving a lowest possible score of 0 (worst outcome), and a highest possible score of 150 (optimal outcome).

  17. Intensity of nausea/vomiting

    Time frame: At 24 hours after surgery

    Pre-established analysis of nausea/vomiting intensity at 24 hours based on the QoR-15 question

  18. Pain intensity

    Time frame: At 24 hours after surgery

    Pre-established analysis of pain intensity at 24 hours based on the QoR-15

  19. Quality of sleep

    Time frame: At 24 hours after surgery

    Pre-established analysis of sleep quality at 24 hours based on the QoR-15

  20. Surgeon's satisfaction towards spinal anesthesia

    Time frame: At the end of surgery, on the day of randomization

    Unsatisfied or satisfied

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Desroches, PhD

CONTACT

[email protected]

514-890-8000 ext. 24542

Stephan Williams, MD, PhD

CONTACT

[email protected]

514-890-8000 ext. 12132

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.