Evaluating the Effect of Intravenous Dexamethasone on the Duration of Spinal Anesthesia After Cesarean Delivery

NCT05731960 | Recruiting Phase 4 DMC

• 1 other identifier: 1028461
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the effects of intravenous (IV) dexamethasone on spinal anesthesia in healthy women having an elective Cesarean delivery (CD) at the IWK Health Centre. The main questions it aims to answer are:

1. 1.What effect does IV dexamethasone have on the resolution of motor blockade in patients having spinal anesthesia for elective CDs?
2. 2.What effect does IV dexamethasone have on the sensory recovery of spinal blockade, the total hydromorphone requirement in the first 24 h postoperatively, the incidence of pruritis perioperatively, and the incidence of nausea and vomiting?

Conditions

Spinal Anesthesia; Dexamethasone

Keywords

spinal anesthesia; dexamethasone; motor block

Outcome Measures

Primary Outcomes (1)

• Resolution of motor blockade assessed by the Bromage motor blockade score

  A Bromage score is quantified from 1 to 4, where a score of 1 indicates a complete block and patients are unable to move their feet or knees. A score of 2 indicates patients are able to only move their feet, while a score of 3 indicates slight knee movement and movement of the feet. A score of 4 indicates full flexion of the knees and feet. When a Bromage score of 3 is reached, assessments will instead occur every 3-5 minutes until a Bromage of 4 is achieved and confirmed bilaterally with a second assessment 1-minute later. If needed, assessments will continue to occur every 3-5 minutes until a Bromage score of 4 is reached bilaterally. The time will be recorded to specify the hour and minute of each assessment. A Bromage score of 4 indicates the endpoint.

  Upon entrance to PACU until a Bromage score of 4 is achieved bilaterally

Secondary Outcomes (6)

• Sensory recovery of spinal blockade assessed by dermatome testing

  Upon entrance to PACU until sensory is achieved bilaterally at L3

• Total opioid requirement (mg) in the first 24 hours postoperatively

  Retrieved at 24 hours following spinal anesthesia.

• Pain scores assessed by NRS

  Every hour postoperatively until a Bromage score of 4 is achieved.

• Nausea intensity scores assessed by NRS

  Every hour postoperatively until a Bromage score of 4 is achieved.

• Incidence of pruritis (itching)

  Post-operatively at time of PACU discharge

Study Arms (2)

Dexamethasone (Group SD)

EXPERIMENTAL

10 mg IV dexamethasone x1

Drug: Dexamethasone

Metoclopramide (Group SM)

ACTIVE COMPARATOR

10 mg IV metoclopramide x1

Drug: Metoclopramide

Interventions

Dexamethasone DRUG

10 mg IV dexamethasone provided immediately after spinal anesthesia

Dexamethasone (Group SD)

Metoclopramide DRUG

10 mg IV metoclopramide provided immediately after spinal anesthesia

Metoclopramide (Group SM)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-emergent Caesarean Delivery with planned spinal anesthesia
• American Society of Anesthesia physical status class \< III
• Age ≥18 years
• Term gestational age (≥37weeks)
• Singleton pregnancy
• Moderate English language fluency

You may not qualify if:

• Obesity (BMI ≥ 45kg/m2)
• Height \< 5'0"
• Patients with significant obstetric or neonatal co-morbidities (i.e., severe maternal cardiac disease, preeclampsia, fetal anomalies)
• Opioid tolerance or sensitivity
• Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
• Contraindication to neuraxial analgesia (i.e., coagulopathy, infection, neuropathy)
• Abnormal spinal anatomy (i.e., severe scoliosis, spina bifida, spinal instrumentation)
• Use of chronic steroids
• A physical or psychiatric condition which impairs cooperation

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

MeSH Terms

Interventions

Dexamethasone; Metoclopramide

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Allana Munro, MD FRCPC

  IWK Health

  PRINCIPAL INVESTIGATOR

• Kwesi Kwofie, MD FRCPC

  IWK Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allana Munro, MD FRCPC

CONTACT

902-470-6627; ammunro@dal.ca

Kwesi Kwofie, MD FRCPC

CONTACT

902-470-6627; kwesi.kwofie@dal.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 16, 2023
• Study Start: March 6, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)