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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04778189
Enrollment
200
Registered
2021-03-02
Start date
2021-12-01
Completion date
2023-05-01
Last updated
2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia

Keywords

i.v dexamethasone, hyperparic bupivacaine

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.

Interventions

DRUGPlacebo

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

DRUGi.v dexmethasone

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

patients will be scheduled for lower abdominal surgery under spinal anesthesia will randomly be allocated into two groups, group SD and group SN, After placement of standard monitors and peripheral IV access, with aseptic technique we will insert, a 25-G pencil-point Pencan(B. Braun, Mississauga, Ontario, Canada) needle intrathecally at the L4-5 or L3-4 interspace, with the patient in a seated position. We will confirm Intrathecal positioning by observation of cerebrospinal fluid return through the needle. Then we will inject the hyperbaric bupivacaine. All patients will receive spinal anesthesia with 12-mg hyperbaric bupivacaine 0.5%. Patients will be randomly assigned to one of the 2 Groups. Beginning during the intrathecal injection, patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline (total, 502 mL), while patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes,

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
regression of sensory block5, 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026