Spinal AnesthesiaPhase 2NCT04778189
Effect of Intravenous Dexamethasone on Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery
A Phase 2 study testing i.v dexmethasone in people with Spinal Anesthesia, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- i.v dexmethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with American Society of Anesthesiologists score I-III,
- Patients undergoing lower abdominal surgery under hyperbaric bupivacaine spinal anesthesia
Who cannot join
- History of allergy to amide LAs or dexamethasone,
- Presence of a preexisting lower limb neurological deficit
- Chronic use of corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Dexamethasone on the Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery, Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Spinal Anesthesia
- Being tested
- Placebo, i.v dexmethasone
- Keywords
- i.v dexamethasone, hyperparic bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
while patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes, after spinal anesthesia
i.v dexmethasoneDrug
patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline after spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| normal saline group (NS) | Placebo comparator | patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes after spinal anesthesia Receives: 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 Receives: Drug: i.v dexmethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
regression of sensory block
Onset to regression of 2 dermatomes evaluated using a Von Frey6.1-g filament (Bioseb; North Coast Medical, Gilroy, CA)
Measured: 5, 10, 20, and 30 minutes after injection of local anesthetic(LA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Dec 2021
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Hassan Abdel-Wahab, Assiut University
- Investigators
- Amani H Abdel-wahab, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778189
- Sponsor's protocol ID
- AssiutU_dexamethasone
- Status last verified
- May 2023
- First submitted
- 25 Feb 2021
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37736711
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Dexamethasone on the Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04778189
- Acronym / sponsor ID
- AssiutU_dexamethasone
- Conditions
- Spinal Anesthesia
- Keywords
- i.v dexamethasone, hyperparic bupivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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,
| Arm | Type | Receives |
|---|---|---|
| normal saline group (NS) | Placebo comparator | Drug: Placebopatients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes after spinal anesthesia |
| dexamethasone group (SD) | Active comparator | Drug: i.v dexmethasonepatients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline in 5-10 minutes after spinal anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with American Society of Anesthesiologists score I-III,
- Patients undergoing lower abdominal surgery under hyperbaric bupivacaine spinal anesthesia
Key exclusion criteria (3 listed)
- History of allergy to amide LAs or dexamethasone,
- Presence of a preexisting lower limb neurological deficit
- Chronic use of corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebowhile patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes, after spinal anesthesia | Drug | normal saline group (NS) |
| i.v dexmethasonepatients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline after spinal anesthesia | Drug | dexamethasone group (SD) |
Primary outcome
regression of sensory block
Time frame: 5, 10, 20, and 30 minutes after injection of local anesthetic(LA)
Onset to regression of 2 dermatomes evaluated using a Von Frey6.1-g filament (Bioseb; North Coast Medical, Gilroy, CA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Derived from this study: PubMed 37736711Abdel-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.
- Individual participant dataSharing planned: No
Related trials for Spinal Anesthesia
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amani H Abdel-wahab, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing i.v dexmethasone in people with Spinal Anesthesia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regression of sensory block (time frame: 5, 10, 20, and 30 minutes after injection of local anesthetic(LA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04778189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.