Opioid UseNCT05850468
Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.
A study testing fentanyl infusion after general anesthesia and erector spinea block and lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block in people with Opioid Use and Spine Fusion, run by Ain Shams University at 1 site in Egypt.
Trial summary
opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use, Spine Fusion
- What is being tested?
- fentanyl infusion after general anesthesia and erector spinea block and lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- May 2023to Nov 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spine surgery ASAI,II
Who cannot join
- revision surgery hypotension bradycardia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assistant Professor of Anesthesia, Intensive Care and Pain Management
opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries
Read the detailed description
patients who will undergo spine surgery will be allocated into two groups. after general anesthesia, bilateral erector spine block will be applied in both groups. group A will have intraoperative fentanyl infusion and group B will have lidocaine and dexmedetomidine infusion in 50 ml syringe till end of surgery
- Conditions
- Opioid Use, Spine Fusion
- Being tested
- fentanyl infusion after general anesthesia and erector spinea block, lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block
- Keywords
- multimodal analgesia, regional blocks, spine surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl infusion after general anesthesia and erector spinea blockDrug
Also called opioid infusion
intraoperative opioid infusion in active comparative group
lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea blockDrug
Also called lidocaine 2% and precedex infusion
intraoperative non opioid infusion in experimental group
| Study group | Role | What they receive |
|---|---|---|
| traditinal balanced anesthesia | Active comparator | fentanyl infusion after general anesthesia and erector spinea block Receives: Drug: fentanyl infusion after general anesthesia and erector spinea block |
| opioid free anesthesia | Experimental | lidocaine and dextometidine infusion after general anesthesia and erector spinea block Receives: Drug: lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients (percentage) having intraoperative systolic hypertension
blood pressure more than 160 mmhg
Measured: during operation(intraoperatively)
number of patients(percentage) having tachycardia
heart rate more than 100 beat /minute
Measured: during operation(intraoperatively)
Secondary outcomes (2)
VAS score
score from 0 to 10, 0 is no pain and 10 the worst pain
Measured: every 30 minutes for 2 hours postoperatively
incidence of bradycardia
heart rate less than 45 beat per minute
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study startMay 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
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 Opioid UseStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sanaa wasfy, professor, Principal investigator, assistant professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850468
- Sponsor's protocol ID
- MS81/2023
- Status last verified
- Mar 2023
- First submitted
- 18 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rowland M, Thomson PD, Guichard A, Melmon KL. Disposition kinetics of lidocaine in normal subjects. Ann N Y Acad Sci. 1971 Jul 6;179:383-98. doi: 10.1111/j.1749-6632.1971.tb46915.x. No abstract available.
PubMed 5285383
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor of Anesthesia, Intensive Care and Pain Management
- ClinicalTrials.gov ID
- NCT05850468
- Acronym / sponsor ID
- MS81/2023
- Conditions
- Opioid Use, Spine Fusion
- Keywords
- multimodal analgesia, regional blocks, spine surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 9 May 2023 (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.
opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries
Detailed description
patients who will undergo spine surgery will be allocated into two groups. after general anesthesia, bilateral erector spine block will be applied in both groups. group A will have intraoperative fentanyl infusion and group B will have lidocaine and dexmedetomidine infusion in 50 ml syringe till end of surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditinal balanced anesthesia | Active comparator | Drug: fentanyl infusion after general anesthesia and erector spinea blockfentanyl infusion after general anesthesia and erector spinea block |
| opioid free anesthesia | Experimental | Drug: lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea blocklidocaine and dextometidine infusion after general anesthesia and erector spinea block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- spine surgery ASAI,II
Key exclusion criteria (1 listed)
- revision surgery hypotension bradycardia
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 |
|---|---|---|
| fentanyl infusion after general anesthesia and erector spinea blockAlso: opioid infusionintraoperative opioid infusion in active comparative group | Drug | traditinal balanced anesthesia |
| lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea blockAlso: lidocaine 2% and precedex infusionintraoperative non opioid infusion in experimental group | Drug | opioid free anesthesia |
Primary outcome
number of patients (percentage) having intraoperative systolic hypertension
Time frame: during operation(intraoperatively)
blood pressure more than 160 mmhg
number of patients(percentage) having tachycardia
Time frame: during operation(intraoperatively)
heart rate more than 100 beat /minute
2 secondary outcomes
VAS score
Time frame: every 30 minutes for 2 hours postoperatively
incidence of bradycardia
Time frame: intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 5285383Rowland M, Thomson PD, Guichard A, Melmon KL. Disposition kinetics of lidocaine in normal subjects. Ann N Y Acad Sci. 1971 Jul 6;179:383-98. doi: 10.1111/j.1749-6632.1971.tb46915.x. No abstract available.
- Individual participant dataSharing planned: No
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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.
sanaa wasfy, professor principal investigator
assistant professor of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl infusion after general anesthesia and erector spinea block and lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block in people with Opioid Use and Spine Fusion, run by Ain Shams 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sanaa wasfy, professor (01061262757, sanaawasfy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients (percentage) having intraoperative systolic hypertension (time frame: during operation(intraoperatively)). The study lists 2 primary outcomes in all. 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 NCT05850468, 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 9 May 2023.