The Effect of IV Dexamethasone on the Duration of Analgesia of Spinal Anaesthesia for C-Sections at a Jamaican Hospital

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Dexamethasone is one of many adjuncts tested to prolong the duration of spinal anesthesia and its analgesic effect. The intent of this, a single-site, double-blinded, randomized controlled trial, is to determine if a single intravenous (IV) 8 mg dose of Dexamethasone given after clamping of the umbilical cord at Caesarean section will prolong the duration of analgesia provided by spinal anesthesia when compared to placebo. This has the power to determine if the findings in previous studies hold true in the population of women who undergo C-sections at the Victoria Jubilee Hospital. This method does not require expert skill and equipment, as such, it can be easily implemented, with no major adverse effects in the population described and provide an effective option for multimodal analgesia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of The West Indies
• Collaborator: National Health Fund of Jamaica
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

• Patients at Victoria Jubilee Hospital in Jamaica, scheduled for non-emergent LSCS under spinal anesthesia

• Age: 18 to 45 years

• Gestational Age: 37 weeks or more

• American Society of Anesthesiologists physical status class II

• Singleton fetus

Exclusion Criteria:

• Emergent Indication for caesarean section including, but not limited to:

• Fetal distress

• Cord prolapse

• Eclampsia

• Severe pre-eclampsia

• Placental abruption

• Placenta praevia

• Multiple Gestation

• Allergy to glucocorticoids/opioids/Diclofenac Na/ local anesthetics

• Contra-indication to Spinal Anesthesia

• Gestational Diabetes or Pre-gestational Diabetes

• Asthma

• Other uncontrolled comorbidities (such as cardiac, respiratory, renal, inflammatory, endocrine disease)

• Chronic steroid use

• history of Peptic Ulcer Disease or Glaucoma

• history of chronic pain

• Illicit drug users (including marijuana)

• Any patient who requires general anesthesia secondary to failure of spinal anesthesia will also be excluded