Dexamethasone for Prolonged Sensory and Motor Block
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a single dose of dexamethasone, a medication, can extend the numbness and lack of movement experienced after spinal anesthesia for lower body surgery. The goal is to determine if dexamethasone prolongs the effects of anesthesia compared to a placebo (a substance with no active drug). Individuals planning to undergo lower body surgery with spinal anesthesia, who do not have nerve-related issues or allergies to the medication, might be suitable candidates for this trial.
As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially improve anesthesia effectiveness for future patients.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that dexamethasone, administered intravenously, is generally safe for people. Studies have found that it can prolong the numbness from anesthesia without causing major side effects.
One study found that dexamethasone extended the numbness from a nerve block by about 37%. This means the drug helps anesthesia last longer, which can be beneficial during surgeries or procedures requiring numbness.
The FDA has already approved dexamethasone for other treatments, supporting its safety. This past use demonstrates its safety at doses similar to those in the study.
Overall, while any medication can have side effects, research suggests that dexamethasone is generally safe and well-tolerated when used correctly in medical settings.12345Why are researchers excited about this trial?
Most treatments for prolonging sensory and motor block during spinal anesthesia rely on local anesthetics and adjuncts like opioids. However, dexamethasone stands out because it's a steroid that works by reducing inflammation and modulating the body's immune response, which might extend the duration of nerve block without the side effects seen with opioids. Another exciting aspect is its intravenous administration, offering a potentially simpler and faster method to enhance the anesthesia effect compared to traditional methods. Researchers are eager to see if dexamethasone can offer a more efficient and patient-friendly approach to managing pain during procedures.
What evidence suggests that dexamethasone might be an effective treatment for prolonged sensory and motor block?
Research has shown that adding dexamethasone to anesthesia can prolong numbness and immobility. In this trial, participants will receive either intravenous dexamethasone or a placebo of normal saline during spinal anesthesia. Studies have found that administering dexamethasone either intravenously or near the nerves extends the time before sensation returns after surgery, compared to a placebo. A review of over 800 patients revealed that dexamethasone consistently increased the duration of numbness and immobility. Patients also reported experiencing less pain and requiring fewer painkillers when dexamethasone was used. These findings suggest that dexamethasone could enhance the effectiveness of anesthesia, providing better pain relief.24678
Who Is on the Research Team?
Stephan Williams, MD, PhD
Principal Investigator
Santé Québec - CHUM
Are You a Good Fit for This Trial?
This trial is for adults who are receiving spinal anesthesia with chloroprocaine. People cannot join if they have conditions or allergies that would make dexamethasone unsafe, but specific inclusion and exclusion details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive spinal anesthesia with chloroprocaine and either intravenous dexamethasone or placebo
Immediate Postoperative Monitoring
Participants are monitored for sensory and motor block regression, and incidence of side effects such as hypotension, bradycardia, nausea, and vomiting
Follow-up
Participants are assessed for quality of recovery, pain intensity, and other postoperative outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
Trial Overview
The study compares a single dose of intravenous dexamethasone (8 mg) to a placebo (normal saline) to see how each affects the length of numbness and muscle weakness after spinal anesthesia with chloroprocaine.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Citations
Perineural Versus Intravenous Dexamethasone for ...
Our meta-analysis demonstrated that PN DEX is superior to IV DEX for prolonging the postoperative analgesic time, sensory block, and motor block. Nev ...
Perineural vs. IV Dexamethasone with Peripheral Nerve ...
Most studies demonstrate that both routes significantly prolong sensory block duration and postoperative analgesia compared with placebo.
Effects of dexamethasone as a local anaesthetic adjuvant for ...
In this systematic review of 9 studies and 801 patients, the authors demonstrate the reliable prolongation of sensory and motor block after local anaesthesia ...
Does The Addition Of Dexamethasone To Local Anesthetic ...
Secondary outcomes included: length of sensory and motor block, pain satisfaction scores, analgesic requirements, and block-related complications. It was found ...
Pain Does dexamethasone have a perineural mechanism ...
Our primary outcome was the duration of sensory block assessed by temperature discrimination in the saphenous distribution. Secondary outcomes were sensory ...
6.
ovid.com
ovid.com/journals/pnmed/pdf/10.1111/pme.12150~duration-of-upper-and-lower-extremity-peripheral-nerveDuration of Upper and Lower Extremity Peripheral Nerve ...
In our practice, dexamethasone is typically less likely to be added to the local anesthetic for the nerve block in patients with history of diabetes or who had ...
Perineural dexamethasone added to local anesthesia for ...
Perineural dexamethasone added to local anesthesia for brachial plexus block improves pain but delays block onset and motor blockade recovery.
a randomised, triple-blinded crossover study in volunteers
In conclusion, we found no evidence of a beneficial effect of perineural or i.v. dexamethasone 4 mg in prolonging sensory block with ropivacaine ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.