Clinical trial NCT04778189: Effect of Intravenous Dexamethasone on Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery
Official title: Effect of Intravenous Dexamethasone on the Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Anesthesia
Keywords: i.v dexamethasone
hyperparic bupivacaine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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,
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: regression of sensory block
timeFrame: 5, 10, 20, and 30 minutes after injection of local anesthetic(LA)
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: faculty of medicine Assiut university
Study officials:
affiliation: Assiut University
name: Amani H Abdel-wahab, MD
role: PRINCIPAL_INVESTIGATOR
References: