Spinal AnesthesiaNCT07837674
Impact of Intravenous Dexamethasone on the Duration of Motor and Sensory Block Following Spinal Anesthesia With Chloroprocaine
A study testing Intravenous Dexamethasone and Normal Saline in people with Spinal Anesthesia and Prolonged Sensory Block, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spinal Anesthesia, Prolonged Sensory Block, Prolonged Motor Block
- What is being tested?
- Intravenous Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Santé Québec - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Stephan Williams, MD, PhD, 514-890-8000 ext. 12132, stephan.williams@umontreal.ca
Julie Desroches, PhD, 514-890-8000 ext. 24542, anesthesie.recherche.chum@ssss.gouv.qc.ca
About this study
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.
Read the detailed description
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.
- Being tested
- Intravenous Dexamethasone, Normal Saline
- Keywords
- Dexamethasone, Chloroprocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous DexamethasoneDrug
Also called Decadron
Administration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia with chloprocaine
Normal SalineDrug
Also called Placebo
Administration of a single-dose of Normal saline during spinal anesthesia with chloprocaine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At regression of spinal anesthesia by 2 dermatomes, approximately 60 minutes after surgery
Secondary outcomes (20)
Duration of motor block
Using the Bromage scale from the time of injection of chloroprocaine for spinal anesthesia until complete recovery of motor block
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 30 minutes following spinal anesthesia
Quality of motor block
Maximal Bromage score The Bromage scale is a standardized tool used in neuraxial anesthesia to quantify motor block intensity in the lower extremities. It assesses a patient's ability to move their legs and feet. A scale of 0 to 3 is used: 0 - Full movement, 1- Partial block, 2 - Nearly complete block and 3 - Complete block.
The maximal Bromage score reflects the deepest level of lower-limb motor block, with higher scores indicating stronger motor impairment and therefore a denser motor block.
Measured: Up to 30 minutes following spinal anesthesia
Opioid consumption
Total dose of opioids
Measured: At recovery room discharge, approximately one hour after the end of surgery
Antiemetic consumption
Total dose of antiemetics
Measured: At recovery room discharge, approximately one hour after the end of surgery
Incidence of hypotension
Systolic blood pressure lower than 90 mm Hg
Measured: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery
Incidence of bradycardia
Heart rate slower than 50 beats per minute
Measured: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery
Incidence of nausea
Any episode of nausea reported by the patient or nursing team
Measured: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery
Incidence of vomiting
Any episode of retching or vomiting reported by the patient or nursing team
Measured: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery
Incidence of itching
Any episode of itching reported by the patient or nursing team
Measured: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery
Incidence of urinary retention
Any episode of urinary retention reported by the patient or nursing team
Measured: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery
Incidence of shivering
Any episode of shivering reported by the patient or nursing team
Measured: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery
Incidence of headache
Any episode of headache reported by the patient or nursing team
Measured: From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery
Quality of postoperative recovery
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).
Measured: At 24 hours after the surgery
Intensity of nausea/vomiting
Pre-established analysis of nausea/vomiting intensity at 24 hours based on the QoR-15 question. 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).
Measured: At 24 hours after surgery
Pain intensity
Pre-established analysis of pain intensity at 24 hours based on the QoR-15. 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).
Measured: At 24 hours after surgery
Quality of sleep
Pre-established analysis of sleep quality at 24 hours based on the QoR-15. 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).
Measured: At 24 hours after surgery
Surgeon's satisfaction towards spinal anesthesia
Unsatisfied or satisfied
Measured: At the end of surgery, on the day of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Williams, MD, PhD, Principal investigator, Santé Québec - CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837674
- Sponsor's protocol ID
- 2027-13916
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intravenous Dexamethasone on the Duration of Motor and Sensory Block Following Spinal Anesthesia With Chloroprocaine
- ClinicalTrials.gov ID
- NCT07837674
- Acronym / sponsor ID
- 2027-13916
- Keywords
- Dexamethasone, Chloroprocaine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Intravenous dexamethasone | Active comparator | Drug: Intravenous DexamethasoneDuring 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. |
| Intravenous normal saline | Placebo comparator | Drug: Normal SalineDuring 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous DexamethasoneAlso: DecadronAdministration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia with chloprocaine | Drug | Intravenous dexamethasone |
| Normal SalineAlso: PlaceboAdministration of a single-dose of Normal saline during spinal anesthesia with chloprocaine | Drug | Intravenous normal saline |
Primary outcome
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
20 secondary outcomes
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
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
Onset of sensory block
Time frame: Up to 30 minutes following spinal anesthesia
Onset of motor block
Time frame: Up to 30 minutes following spinal anesthesia
Quality of motor block
Time frame: Up to 30 minutes following spinal anesthesia
Opioid consumption
Time frame: At recovery room discharge, approximately one hour after the end of surgery
Antiemetic consumption
Time frame: At recovery room discharge, approximately one hour after the end of surgery
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
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
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
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
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
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
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
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
Quality of postoperative recovery
Time frame: At 24 hours after the surgery
Intensity of nausea/vomiting
Time frame: At 24 hours after surgery
Pain intensity
Time frame: At 24 hours after surgery
Quality of sleep
Time frame: At 24 hours after surgery
Surgeon's satisfaction towards spinal anesthesia
Time frame: At the end of surgery, on the day of randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephan Williams, MD, PhD principal investigator
Santé Québec - CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Dexamethasone and Normal Saline in people with Spinal Anesthesia and Prolonged Sensory Block, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan Williams, MD, PhD (514-890-8000 ext. 12132, stephan.williams@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression of sensory block by 2 dermatomes (time frame: At regression of spinal anesthesia by 2 dermatomes, approximately 60 minutes after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.