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Completed

NCT Number: NCT04778189

Effect of Intravenous Dexamethasone on Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery

The use of dexamethasone, administered either systemically or perineurally, as an adjunct to peripheral or neuraxial regional blocks, is currently one of the hottest topics in the field of regional anesthesia.

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Key information

Conditions

Spinal Anesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

faculty of medicine Assiut university

Asyut, Egypt

About this study

A large number of clinical studies have investigated this off-label application of dexamethasone in recent years, with many reporting enhanced sensory block and/or improved postoperative analgesia following either intravenous (i.v.) or perineural dexamethasone. Dexamethasone is potent, selective glucocorticoid having minimal mineralocorticoid action. Systemic anti-inflammatory and immunosuppressive properties may be responsible for the prolongation of analgesia when administered intravenously. Various studies proved the efficacy of steroids for the prolongation of the effects of regional nerve blocks. We decided to conduct the present study to evaluate the effects of intravenous (IV) dexamethasone on the subarachnoid block.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with American Society of Anesthesiologists score I-III,
  • Patients undergoing lower abdominal surgery under hyperbaric bupivacaine spinal anesthesia

Exclusion criteria

  • History of allergy to amide LAs or dexamethasone,
  • Presence of a preexisting lower limb neurological deficit
  • Chronic use of corticosteroids.

Treatment and study plan

Placebo

Drug

while patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes, after spinal anesthesia

i.v dexmethasone

Drug

patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline after spinal anesthesia

Primary outcomes

  1. regression of sensory block

    Time frame: 5, 10, 20, and 30 minutes after injection of local anesthetic(LA)

    Onset to regression of 2 dermatomes evaluated using a Von Frey6.1-g filament (Bioseb; North Coast Medical, Gilroy, CA)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Intravenous Dexamethasone on the Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery, Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2021
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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