Spinal AnesthesiaNCT03078062
Impact of Dexamethasone on the Duration of Sensory and Motor Block Following Spinal Anesthesia
A study testing 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 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. 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?
- 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
- 26 May 2017to 26 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients undergoing lower body surgery under spinal anesthesia
- American Society of Anesthesiologists' physical status of 1 to 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
Official title: Impact of Intravenous Dexamethasone on the Duration of Sensory and Motor Block Following a Bupivacaine-based Spinal Anesthesia
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.
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.
Using intravenous or intrathecal adjuvants to local anesthetics may prolong the duration of sensory and motor blockade following spinal anesthesia. Various intrathecal additives have been studied such as opioids, adrenalin, clonidine, dexmedetomidine, midazolam, ketamine, magnesium, ketorolac and neostigmine. Most of them failed to prolong the duration of spinal anesthesia and side-effects have restricted their use.
Dexamethasone is a potent corticosteroid with a half-life of 36 to 72 hours and an onset of action of 1 to 2 hours. The safety of single doses of intravenous dexamethasone is well documented. Dexamethasone is widely used in anesthesia to prevent nausea and vomiting and treat post-extubation sore throat and postoperative shivering. It is also increasingly used in orthopaedic surgery to reduce opioid needs without increasing the risks of infection, wound dehiscence and osteonecrosis. The use of dexamethasone in the perioperative period reduces postoperative edema allowing early mobilization and improved functional recovery.
Recent studies have demonstrated that both perineural and intrathecal administration of dexamethasone can prolong the duration of peripheral and spinal anesthesia. However, dexamethasone has not been approved by health authorities for these indications and thus, the safety of this practice remains controversial. A recent study has compared peripheral to intravenous administration of dexamethasone for interscalene blocks. This study demonstrated the equivalency of these regimens in increasing the analgesic duration of a single-shot interscalene block.
The impact of intravenous dexamethasone on the duration of spinal anesthesia remains unknown. This study will investigate the effect of a single-dose of dexamethasone 8 mg on the duration of the sensory and motor block following spinal anesthesia.
Sixty patients scheduled for lower body surgery under spinal anesthesia will be considered for this study.
After placement of standard non-invasive monitoring, spinal anesthesia will be performed in the sitting position using a 25 gauge (GA) pencil point needle (Whitacre, Pencan). After aspiration of cerebrospinal fluid (CSF), a dose of isobaric 0.5% bupivacaine 12 mg will be injected. The aspiration of CSF will be repeated at the end of the injection. While performing spinal anesthesia, an intravenous infusion of dexamethasone 8 mg or placebo will be initiated according to randomization.
Subsequently, the patient will be placed in supine position. Sensory block will be measured by loss of sensation to pinprick at 5, 10, 20 and 30 minutes following spinal anesthesia and then every 15 minutes until confirmation of regression by two dermatomes. Loss of sensation will be assessed every 30 minutes thereafter. Motor block will be assessed using the Bromage scale at the same frequency until full recovery.
Sedation will be allowed during the performance of the spinal anesthesia technique and surgery. In case of unsatisfactory quality of spinal anesthesia, general anesthesia will be performed.
At the end of surgery, patients will be transferred to the recovery room. Multimodal analgesia including celecoxib and acetaminophen will be administered. Pain will be assessed using a verbal numeric pain scale (VNPS) of 0 to 10, where 0 means "No pain" and 10 means "Worst pain imaginable". Intravenous hydromorphone will be administered when VNPS is superior to 3. Postoperative nausea and vomiting will be managed with intravenous ondansetron, dimenhydrinate and haloperidol.
Opioid intake, presence of side-effects and quality of sleep will be assessed during the first 24 hours following surgery.
- Being tested
- Dexamethasone, Normal saline
- Keywords
- Spinal anesthesia, Motor block, Sensory block, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
Administration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia
Normal salineDrug
Also called Placebo
Administration of a single-dose of Normal saline during spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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 bupivacaine 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 2 hours after surgery
Secondary outcomes (16)
Duration of motor block
Using the Bromage scale from the time of injection of bupivacaine for spinal anesthesia until complete recovery of motor block
Measured: 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
Time from injection of bupivacaine 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 bupivacaine 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
Measured: Up to 30 minutes following spinal anesthesia
Surgeon's satisfaction towards spinal anesthesia
Unsatisfied or satisfied
Measured: At the end of surgery, on the day of randomization
Time to first analgesic request
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"
Measured: From the end of surgery up to approximately six hours after surgery, on the day of randomization
Opioid consumption
Total dose of opioids
Measured: At recovery room discharge, approximately one hour after the end of surgery on the day of randomization and 24 hours following surgery
Incidence of hypotension
Systolic blood pressure lower than 90 mm Hg
Measured: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of bradycardia
Heart rate slower than 50 beats per minute
Measured: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of nausea
Any episode of nausea reported by the patient or nursing team
Measured: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of vomiting
Any episode of retching or vomiting reported by the patient or nursing team
Measured: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of urinary retention
Any episode of urinary retention reported by the patient or nursing team
Measured: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of shivering
Any episode of shivering reported by the patient or nursing team
Measured: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of headache
Any episode of headache reported by the patient or nursing team
Measured: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Quality of sleep
Described by the patient as good or bad
Measured: At 24 hours after surgery
Duration of sensory block
Loss of pinprick sensation by Von Frey filaments from the injection of bupivacaine for spinal anesthesia until complete recovery
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start26 May 2017
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
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 (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan R Williams, Md, PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078062
- Sponsor's protocol ID
- 16.374
- Status last verified
- Oct 2017
- First submitted
- 3 Mar 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intravenous Dexamethasone on the Duration of Sensory and Motor Block Following a Bupivacaine-based Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03078062
- Acronym / sponsor ID
- 16.374
- Keywords
- Spinal anesthesia, Motor block, Sensory block, Dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 13 Mar 2017 (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 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.
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.
Using intravenous or intrathecal adjuvants to local anesthetics may prolong the duration of sensory and motor blockade following spinal anesthesia. Various intrathecal additives have been studied such as opioids, adrenalin, clonidine, dexmedetomidine, midazolam, ketamine, magnesium, ketorolac and neostigmine. Most of them failed to prolong the duration of spinal anesthesia and side-effects have restricted their use.
Dexamethasone is a potent corticosteroid with a half-life of 36 to 72 hours and an onset of action of 1 to 2 hours. The safety of single doses of intravenous dexamethasone is well documented. Dexamethasone is widely used in anesthesia to prevent nausea and vomiting and treat post-extubation sore throat and postoperative shivering. It is also increasingly used in orthopaedic surgery to reduce opioid needs without increasing the risks of infection, wound dehiscence and osteonecrosis. The use of dexamethasone in the perioperative period reduces postoperative edema allowing early mobilization and improved functional recovery.
Recent studies have demonstrated that both perineural and intrathecal administration of dexamethasone can prolong the duration of peripheral and spinal anesthesia. However, dexamethasone has not been approved by health authorities for these indications and thus, the safety of this practice remains controversial. A recent study has compared peripheral to intravenous administration of dexamethasone for interscalene blocks. This study demonstrated the equivalency of these regimens in increasing the analgesic duration of a single-shot interscalene block.
The impact of intravenous dexamethasone on the duration of spinal anesthesia remains unknown. This study will investigate the effect of a single-dose of dexamethasone 8 mg on the duration of the sensory and motor block following spinal anesthesia.
Sixty patients scheduled for lower body surgery under spinal anesthesia will be considered for this study.
After placement of standard non-invasive monitoring, spinal anesthesia will be performed in the sitting position using a 25 gauge (GA) pencil point needle (Whitacre, Pencan). After aspiration of cerebrospinal fluid (CSF), a dose of isobaric 0.5% bupivacaine 12 mg will be injected. The aspiration of CSF will be repeated at the end of the injection. While performing spinal anesthesia, an intravenous infusion of dexamethasone 8 mg or placebo will be initiated according to randomization.
Subsequently, the patient will be placed in supine position. Sensory block will be measured by loss of sensation to pinprick at 5, 10, 20 and 30 minutes following spinal anesthesia and then every 15 minutes until confirmation of regression by two dermatomes. Loss of sensation will be assessed every 30 minutes thereafter. Motor block will be assessed using the Bromage scale at the same frequency until full recovery.
Sedation will be allowed during the performance of the spinal anesthesia technique and surgery. In case of unsatisfactory quality of spinal anesthesia, general anesthesia will be performed.
At the end of surgery, patients will be transferred to the recovery room. Multimodal analgesia including celecoxib and acetaminophen will be administered. Pain will be assessed using a verbal numeric pain scale (VNPS) of 0 to 10, where 0 means "No pain" and 10 means "Worst pain imaginable". Intravenous hydromorphone will be administered when VNPS is superior to 3. Postoperative nausea and vomiting will be managed with intravenous ondansetron, dimenhydrinate and haloperidol.
Opioid intake, presence of side-effects and quality of sleep will be assessed during the first 24 hours following surgery.
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 |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneDuring 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. |
| Normal Saline | Placebo comparator | Drug: Normal salineDuring 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing lower body surgery under spinal anesthesia
- American Society of Anesthesiologists' physical status of 1 to 3
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| DexamethasoneAlso: DecadronAdministration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia | Drug | Dexamethasone |
| Normal salineAlso: PlaceboAdministration of a single-dose of Normal saline during spinal anesthesia | Drug | Normal Saline |
Primary outcome
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
16 secondary outcomes
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
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
Surgeon's satisfaction towards spinal anesthesia
Time frame: At the end of surgery, on the day of randomization
Time to first analgesic request
Time frame: From the end of surgery up to approximately six hours after surgery, on the day of randomization
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
Incidence of hypotension
Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of bradycardia
Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of nausea
Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of vomiting
Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of urinary retention
Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of shivering
Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Incidence of headache
Time frame: From injection of bupivacaine for spinal anesthesia to 24 hours after surgery
Quality of sleep
Time frame: At 24 hours after surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stephan R Williams, Md, PhD principal investigator
Centre hospitalier de l'Université de Montréal (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 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 27 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 2 hours 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 27 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.