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

• ClinicalTrials.gov Identifier: NCT04778189
• Recruitment Status: Not yet recruiting
• First Posted: March 2, 2021
• Last Update Posted: September 21, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Amani Hassan Abdel-Wahab, Assiut University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Anesthesia	Drug: Placebo; Drug: i.v dexmethasone	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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,
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Effect of Intravenous Dexamethasone on Regression of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery , Randomized Controlled Trial
• Estimated Study Start Date: December 1, 2021
• Estimated Primary Completion Date: May 1, 2022
• Estimated Study Completion Date: August 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. change in the motor block of spinal anesthesia [ Time Frame: 5, 10, 20, and 30 minutes after injection of local anesthetic(LA) ]
   change of motor block with the Bromage scale{I- Free movement of legs and feet, Nil (0%), II-Just able to flex knees with free movement of feet. Partial (33%), III-Unable to flex knees, but with free movement of feet.Almost complete (66%), IV-Unable to move legs or feet.Complete (100%)}
2. change the sensory block of spinal anesthesia [ Time Frame: 5, 10, 20, and 30 minutes after injection of LA ]
   change of sensory block will be evaluated using a Von Frey6.1-g filament (Bioseb; North Coast Medical, Gilroy, CA)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Amani H Abdel-wahab, MD; 01004610623; amanyabdelwhab@aun.edu.eg

Locations

Egypt

faculty of medicine Assiut university

Assiut, Egypt

Contact: Amani H Abdei-wahab, MD 01004610623 amanyabdelwhab@aun.edu.eg

Sponsors and Collaborators

Assiut University

Investigators

• Principal Investigator: Amani H Abdel-wahab, MD; Assiut University

More Information

• Responsible Party: Amani Hassan Abdel-Wahab, assistant professor, Assiut University
• ClinicalTrials.gov Identifier: NCT04778189
• Other Study ID Numbers: AssiutU_dexamethasone
• First Posted: March 2, 2021
• Last Update Posted: September 21, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amani Hassan Abdel-Wahab, Assiut University:

i.v dexamethasone; hyperparic bupivacaine