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

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04778189
• Other study ID #: AssiutU_dexamethasone
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• Placebo
while patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes, after spinal anesthesia
• i.v dexmethasone
patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline after spinal anesthesia

Locations

Country	Name	City	State
Egypt	faculty of medicine Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regression of sensory block	Onset to regression of 2 dermatomes evaluated using a Von Frey6.1-g filament (Bioseb; North Coast Medical, Gilroy, CA)	5, 10, 20, and 30 minutes after injection of local anesthetic(LA)