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

Assiut University

Status and phase: Completed; Phase 2

Conditions: Spinal Anesthesia

Treatments: Drug: Placebo; Drug: i.v dexmethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04778189

AssiutU_dexamethasone

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

normal saline group (NS)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

dexamethasone group (SD)

Active Comparator group

Description:

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

Treatment:

Drug: i.v dexmethasone