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

Phase 2

Completed

• Conditions: Spinal Anesthesia
• Interventions: Drug: Placebo; Drug: i.v dexmethasone

• Registration Number: NCT04778189
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-02
• Study Start: 2021-12-01
• Primary Completion: 2023-04-01
• Status Verified: 2023-05
• Study Completion: 2023-05-01
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline group (NS)	Placebo	patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes after spinal anesthesia
dexamethasone group (SD)	i.v dexmethasone	patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline in 5-10 minutes after spinal anesthesia

Primary Outcome Measures

Name	Time	Method
regression of sensory block	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)

Trial Locations

Locations (1)

faculty of medicine Assiut university; 🇪🇬 Assiut, Egypt