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

NCT04624360 | Unknown Phase 4 DMC

• 1 other identifier: VJH Dexa Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  The duration of time from the administration of drugs intrathecally for spinal anesthesia to the first request for analgesia or first time the pain score is greater than 4

  first 4 hours after spinal anesthesia administered

Study Arms (2)

Study Drug A

EXPERIMENTAL

Dexamethasone 8mg intravenous administration stat dose post clamping of the umbilical cord

Drug: Dexamethasone

Study Drug B

PLACEBO COMPARATOR

Normal saline 2cc intravenous stat dose administered after clamping of the umbilical cord

Other: Placebo

Interventions

Dexamethasone DRUG

Intravenous of Dexamethasone 8 mg post clamping of the umbilical cord

Also known as: Study Drug A

Study Drug A

Placebo OTHER

2cc 0.9% Saline

Also known as: Study Drug B

Study Drug B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant females undergoing operative delivery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of The West Indies: lead
• National Health Fund of Jamaica: collaborator

Study Sites (1)

Victoria Jubilee Hospital

Kingston, Non-US/Canada, 6, Jamaica

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Christine Stephen, MB;BS, DM

  University of the West Indies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renee Nesbeth, M.B.;B.S.

CONTACT

8765758155; rmnesbeth@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 10, 2020
• Study Start: June 27, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: January 2021 - December 2028

Locations

JA (1)