IV Dexamethasone for Spinal Anesthesia

Overseen By Kwesi Kwofie, MD FRCPC

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: IWK Health Centre

Must not be taking: Chronic steroids, NSAIDs

Disqualifiers: Obesity, Height < 5'0", others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an IV dose of dexamethasone (a steroid) affects spinal anesthesia during planned Cesarean deliveries at the IWK Health Centre. Researchers aim to determine if it aids muscle recovery and reduces the need for pain medication, itching, nausea, and vomiting after surgery. Participants will be divided into two groups to receive either dexamethasone or metoclopramide (another medication for nausea) to compare outcomes. Women planning a C-section with spinal anesthesia and without major health issues may be suitable for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you use chronic steroids, you cannot participate in this trial.

What is the safety track record for these treatments?

Research has shown that dexamethasone is generally well-tolerated in medical settings. Some studies found that it can reduce pain after surgery and extend the effects of spinal anesthesia, meaning less pain for a longer time after the procedure. Regarding safety, other studies have shown that using dexamethasone in similar situations usually does not cause major side effects.

Metoclopramide, the other treatment in this trial, is often used to prevent nausea. It is generally considered safe, though some people might experience minor side effects like fatigue or restlessness. Overall, both treatments have a good safety record, especially when used in controlled settings like this trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using IV dexamethasone for spinal anesthesia because it offers a potential new way to enhance pain management during surgery. Unlike many standard treatments that focus on traditional painkillers, dexamethasone is a steroid that can reduce inflammation and possibly prolong the effects of anesthesia, leading to better pain control. Meanwhile, metoclopramide, typically used to treat nausea, is being explored for its potential to complement anesthesia by improving postoperative comfort. These innovative approaches could provide more effective and comfortable experiences for patients undergoing surgery.

What evidence suggests that this trial's treatments could be effective for spinal anesthesia in elective Cesarean delivery?

Research shows that dexamethasone, which participants in this trial may receive, effectively reduces pain after surgery and lessens the need for opioid painkillers. It also prolongs the effects of spinal anesthesia. Studies have found that it manages low blood pressure during surgery. In women undergoing C-sections, dexamethasone provides pain relief comparable to other treatments. These findings suggest that dexamethasone could improve recovery by reducing the need for pain medication and increasing comfort during and after surgery. Another group in this trial will receive metoclopramide as an active comparator. ^{2 3 6 7 8}

Who Is on the Research Team?

Allana Munro, MD FRCPC

Principal Investigator

IWK Health

Kwesi Kwofie, MD FRCPC

Principal Investigator

IWK Health

Are You a Good Fit for This Trial?

This trial is for healthy women over 18, with a single baby at term (≥37 weeks), planning a non-emergency Cesarean delivery using spinal anesthesia. They should speak moderate English and have an ASA physical status class < III. Excluded are those with contraindications to spinal analgesia, abnormal spine anatomy, significant health issues, height under 5'0", chronic steroid use, NSAID intolerance, opioid sensitivity or tolerance, and severe obesity (BMI ≥45kg/m2).

Inclusion Criteria

I am scheduled for a C-section with spinal anesthesia.

Term gestational age (≥37 weeks)

Singleton pregnancy

Exclusion Criteria

I cannot have spinal or epidural pain relief due to a bleeding disorder, infection, or nerve disease.

I am tolerant or sensitive to opioids.

A physical or psychiatric condition which impairs cooperation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal anesthesia and are randomized to receive either IV dexamethasone or IV metoclopramide immediately after spinal anesthesia

1 day

1 visit (in-person)

Post-Anesthesia Recovery

Participants are monitored in the PACU for motor and sensory recovery, pain, nausea, and other side effects

Until Bromage score of 4 is achieved

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid use and side effects

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Metoclopramide

Trial Overview The study tests if IV dexamethasone affects the duration of motor and sensory blockade from spinal anesthesia in elective Cesarean deliveries compared to IV metoclopramide. Women will be randomly assigned to receive either dexamethasone or metoclopramide after their anesthesia. Recovery assessments include sensation level checks every 15 minutes until specific recovery criteria are met.

How Is the Trial Designed?

Group I: Dexamethasone (Group SD) Experimental Treatment 1 Intervention

10 mg IV dexamethasone x1

Group II: Metoclopramide (Group SM) Active Control 1 Intervention

10 mg IV metoclopramide x1

Who Is Running the Clinical Trial?

IWK Health Centre

Lead Sponsor

Trials

131

Recruited

112,000+

Published Research Related to This Trial

In a study involving 60 patients undergoing inguinal herniorrhaphy, a single dose of 10 mg dexamethasone did not improve pain relief or reduce the incidence of postoperative nausea and vomiting (PONV) after spinal anesthesia with tetracaine and neostigmine.

The findings suggest that dexamethasone does not enhance the analgesic effects of neostigmine or decrease the severity of nausea and vomiting following intrathecal administration, indicating it may not be beneficial in this specific postoperative context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dexamethasone on postoperative pain and emesis after intrathecal neostigmine. Tan, PH., Liu, K., Peng, CH., et al.[2022]

In a study of 100 female patients undergoing spinal surgery, the combination of ramosetron and dexamethasone significantly reduced the incidence of moderate to severe nausea and vomiting compared to ramosetron alone, indicating improved management of postoperative nausea and vomiting (PONV).

Patients receiving the combination treatment experienced fewer episodes of vomiting (5 vs. 13) and moderate to severe nausea (10 vs. 20), suggesting that adding dexamethasone enhances the efficacy of ramosetron in preventing PONV in those at high risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery. Yang, SY., Jun, NH., Choi, YS., et al.[2022]

In a study of 30 obese patients with impaired glucose tolerance undergoing gastric bypass surgery, those who received 8 mg of dexamethasone showed significantly higher blood glucose levels compared to a control group receiving saline, particularly from 6 to 12 hours post-surgery.

The maximum blood glucose level in the dexamethasone group was 10.4 mmol/L, which was notably higher than the 8.8 mmol/L observed in the control group, indicating that dexamethasone can exacerbate hyperglycemia in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone for postoperative nausea and vomiting prophylaxis: effect on glycaemia in obese patients with impaired glucose tolerance. Nazar, CE., Lacassie, HJ., López, RA., et al.[2022]

Intravenous dexamethasone significantly delayed the regression of hyperbaric bupivacaine spinal anesthesia, leading to longer sensory and motor block durations in 200 patients undergoing lower abdominal surgery.

Patients receiving dexamethasone experienced a longer time until their first postoperative analgesic request and reported lower pain scores, suggesting it can effectively reduce overall analgesic consumption post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. Abdel-Wahab, AH., Abd Alla, ES., Abd El-Azeem, T.[2023]

In a study of 44 patients undergoing unilateral inguinal herniorrhaphy, adding dexamethasone to epidural bupivacaine significantly accelerated the onset of sensory block and prolonged postoperative analgesia compared to bupivacaine alone.

The addition of dexamethasone also reduced the incidence of nausea, with only 22.7% of the control group experiencing nausea in the first hour post-procedure, while none in the dexamethasone group reported nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural Dexamethasone for Postoperative Analgesia in Patients Undergoing Unilateral Inguinal Herniorrhaphy: A Comparative Study. Razavizadeh, MR., Fazel, MR., Heydarian, N., et al.[2018]

In a study of 178 patients undergoing lower extremity orthopedic surgery, intravenous dexamethasone did not significantly reduce the incidence of Post-Dural Puncture Headache (PDPH) compared to a placebo.

However, patients who received dexamethasone experienced less severe headaches, suggesting that it can effectively decrease the intensity of PDPH when given prophylactically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone in preventing post-dural puncture headache: a randomized, double-blind, placebo-controlled trial. Doroudian, MR., Norouzi, M., Esmailie, M., et al.[2022]

In a study of 18,872 hip and knee arthroplasties, a single low dose of dexamethasone (5-10 mg) did not increase the risk of post-operative prosthetic joint infections (PJIs), indicating its safety for use in these surgeries.

Dexamethasone effectively prevents post-operative nausea and vomiting (PONV) and may help reduce post-operative pain without raising infection rates, making it a beneficial option in multimodal pain management for arthroplasty patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infection safety of dexamethasone in total hip and total knee arthroplasty: a study of eighteen thousand, eight hundred and seventy two operations. Vuorinen, MA., Palanne, RA., Mäkinen, TJ., et al.[2020]

In a study of 180 patients undergoing elective surgeries with spinal anesthesia, both diabetic and nondiabetic patients experienced a significant increase in blood glucose levels after receiving low doses of dexamethasone (4 mg and 8 mg).

The maximum rise in blood glucose was similar for both groups, reaching about 40-45 mg/dL, indicating that clinicians should carefully consider the potential for hyperglycemia when administering dexamethasone for preventing postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized study on the impact of low-dose dexamethasone on perioperative blood glucose concentrations in diabetics and nondiabetics. Purushothaman, AM., Pujari, VS., Kadirehally, NB., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11003431/

Effectiveness of Single Intravenous Dexamethasone in ... A single-dose administration of dexamethasone with moderate to high dose reduces postoperative pain, reduces opioid consumption, and prolongs spinal anesthesia ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40823450/

Comparison of Perioperative Single-Dose Systemic ... Dexamethasone administration significantly prolonged postoperative analgesia, with statistically significant VAS score differences observed from ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959289X2400298X

Dexamethasone for prevention of spinal hypotension ... A recent randomised control trial showed that dexamethasone was effective in blunting spinal hypotension in geriatric patients undergoing orthopaedic surgery.

4. journals.lww.com journals.lww.com/sjan/fulltext/2024/18030/efficacy_and_safety_of_adjuvant_intrathecal.12.aspx

Efficacy and safety of adjuvant intrathecal dexamethasone... Patients received concomitant IT dexamethasone as an adjuvant to spinal local anesthetics. The analyzed outcomes included sensory and motor effects as well as ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405603025000767

Effect of dexamethasone versus dexmedetomidine on ... The present study found that both dexmedetomidine and dexamethasone had comparable efficacy and safety profile when used in women undergoing CD under spinal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11323928/

Efficacy and safety of adjuvant intrathecal dexamethasone ... The effect of dexamethasone on duration of motor blockade was inconclusive. Additionally, lower risk ratios (RRs) were recorded for spinal anesthesia-related ...

7. journals.lww.com journals.lww.com/joacp/fulltext/2024/40010/dexamethasone_in_anesthesia_practice__a_narrative.2.aspx

Dexamethasone in anesthesia practice: A narrative review The authors concluded that intermediate dose dexamethasone was safe and effective for postoperative pain relief. Furthermore, dexamethasone in a dose of 8 mg ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07088432

Intravenous Dexamethasone for Prolonging Sensory Block ... The study also looks at whether dexamethasone improves pain control after surgery and whether it causes any side effects.