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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-05-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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,

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexamethasone group (SD)

patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline in 5-10 minutes after spinal anesthesia

Group Type ACTIVE_COMPARATOR

i.v dexmethasone

Intervention Type DRUG

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

normal saline group (NS)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

i.v dexmethasone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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