Dexamethasone for Prolonged Sensory and Motor Block

SW
JD
Overseen ByJulie Desroches, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.12345

Why 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?

SW

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

ASA status I to III inclusively
Signed informed consent form
I am between 18 and 90 years old.
See 1 more

Exclusion Criteria

Impossible post-anesthesia care unit assessment due to patient still intubated, transfer to intensive care unit, research team constraints, or other reasons
Assessment in the recovery room impossible due to medical condition (shock, delirium, major agitation, altered state of consciousness, or other), transfer to intensive care unit, research team constraints, or other
I am unable to give informed consent for medical treatment.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive spinal anesthesia with chloroprocaine and either intravenous dexamethasone or placebo

Approximately 90 minutes
1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for sensory and motor block regression, and incidence of side effects such as hypotension, bradycardia, nausea, and vomiting

Approximately 1 hour after surgery
1 visit (in-person)

Follow-up

Participants are assessed for quality of recovery, pain intensity, and other postoperative outcomes

24 hours after surgery

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

Group I: Intravenous dexamethasoneActive Control1 Intervention
Group II: Intravenous normal salinePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

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 ...

Duration 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 ...