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

ConditionsSpinal AnesthesiaDexamethasone
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIWK Health Centre

About this trial

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. What effect does IV dexamethasone have on the resolution of motor blockade in patients having spinal anesthesia for elective CDs? 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?

The spinal anesthesia technique will be standardized and will be administered as per routine care at IWK Health. Computer generation will randomize patients to either Group SD, who will receive IV dexamethasone, or group SM who will receive IV metoclopramide, an alternative anti-emetic, immediately after spinal anesthesia by the attending anesthesia provider. Each patient will receive ondansetron, a second anti- emetic as recommended for Enhanced Recovery After Surgery (ERAS) protocol. Participant sensation, pain, nausea, pruritus, and motor blockade will be assessed in recovery. The patient's sensation and Bromage score will be assessed every 15 minutes until sensation is reached at L3 and a Bromage score of 4 is achieved.

The investigators will determine if there is a difference between groups regarding motor blockade, the length of time of spinal anesthesia, and side effects after CD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non-emergent Caesarean Delivery with planned spinal anesthesia

American Society of Anesthesia physical status class < III

Age ≥18 years

Term gestational age (≥37weeks)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    10 mg IV dexamethasone provided immediately after spinal anesthesia

  • Metoclopramide

    Drug

    10 mg IV metoclopramide provided immediately after spinal anesthesia

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: Dexamethasone (Group SD)Experimental treatment 1 intervention
Group B: Metoclopramide (Group SM)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Sensory recovery of spinal blockade assessed by dermatome testing

Dermatome assessments using ice will occur every 15-minutes unilaterally. When sensation is reached at L3 (the greater trochanter region of the femur), a bilateral assessment will be taken, and the time will be recorded. If needed, assessments will continue to occur until sensation has been reached at L3 bilaterally. The time will be recorded to specify the hour and minute of each assessment.

Time frame
Upon entrance to PACU until sensory is achieved bilaterally at L3
2

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

Recorded from the Intraoperative Anesthesia Information Management System (in milligrams, mg).

Time frame
Retrieved at 24 hours following spinal anesthesia.
3

Pain scores assessed by NRS

Numeric Rating Scale (NRS) is quantified as 0-10, where 0 is none, 1-3 is mild, 4-6 is moderate, and 7-10 is severe, where 10 represents the worst pain imaginable.

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

Nausea intensity scores assessed by NRS

Numeric Rating Scale (NRS) is quantified as 0-10, where 0 is none, 1-3 is mild, 4-6 is moderate, and 7-10 is severe, where 10 represents the worst nausea intensity imaginable.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IWK Health Centre

Lead sponsor

Source ClinicalTrials.gov
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