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

NCT04778189 | Completed Phase 2 DMC

• 1 other identifier: AssiutU_dexamethasone
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia

Keywords

i.v dexamethasone; hyperparic bupivacaine

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

normal saline group (NS)

PLACEBO COMPARATOR

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

Drug: Placebo

dexamethasone group (SD)

ACTIVE COMPARATOR

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

Drug: i.v dexmethasone

Interventions

Placebo DRUG

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

normal saline group (NS)

i.v dexmethasone DRUG

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

dexamethasone group (SD)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of allergy to amide LAs or dexamethasone,
• Presence of a preexisting lower limb neurological deficit
• Chronic use of corticosteroids.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

faculty of medicine Assiut university

Asyut, Egypt

Location

Related Publications (1)

• Abdel-Wahab AH, Abd Alla ES, Abd El-Azeem T. Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. BMC Anesthesiol. 2023 Sep 22;23(1):323. doi: 10.1186/s12871-023-02282-y.

  PMID: 37736711 DERIVED

Study Officials

• Amani H Abdel-wahab, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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,

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: December 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)