Opioid Free AnesthesiaNCT05312866
Intraoperative Retrolaminar Block as Opioid Free Anesthesia After Posterior Lumber Spine Discectomy
A study testing Standard analgesia (paracetamol +fentanyl) and Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone in people with Opioid Free Anesthesia, run by Zagazig University at 1 site in Egypt.
Trial summary
Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Free Anesthesia
- What is being tested?
- Standard analgesia (paracetamol +fentanyl) and Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Dec 2022
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent from the patient.
- Age: 21-60 years old.
- Sex: both sex (males and females).
- American Society of Anesthesiologist Physical status: ASA 1\& II.
- Body Mass Index (BMI) = (25-30 kg/m2).
- Type of operation: elective posterior Lumbar discectomy from L3 to L5 disc space.
Who cannot join
- Altered mental state.
- Patients with known history of allergy to study drugs.
- Advanced hepatic, renal, cardiovascular, and respiratory diseases.
- Patients with chronic pain.
- Patients receiving anticoagulants.
- Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Human Medicine, Zagazig University
Zagazig, Alsharquia, 44511
About this study
Official title: Intraoperative Retrolaminar Block as Opioid Free Anesthesia and Enhanced Recovery After Posterior Lumber Spine Discectomy: A Randomized Controlled Study
Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain.
Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients
Read the detailed description
- Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
- Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
- Conditions
- Opioid Free Anesthesia
- Being tested
- Standard analgesia (paracetamol +fentanyl), Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard analgesia (paracetamol +fentanyl)Procedure or surgery
Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv
Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasoneProcedure or surgery
Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.
| Study group | Role | What they receive |
|---|---|---|
| Standard analgesia (paracetamol +fentanyl) | Active comparator | Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv Receives: Procedure: Standard analgesia (paracetamol +fentanyl) |
| Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone | Active comparator | Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina. Receives: Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recovery time
The recovery time (time from discontinuation of isoflurane to first response to verbal command) will be recorded, then the patient will be transferred to the post anesthesia care unite (PACU) on standard monitors.
Measured: up to 1 hour postoperative
Secondary outcomes (1)
pain intensity
pain intensity measured using visual analogue scale from 0= no pain to 10= worst pain
Measured: up to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 May 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Free AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alshaimaa Abdel Fattah Kamel, Zagazig University
- Investigators
- Alshaimaa Kamel, M.D, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312866
- Sponsor's protocol ID
- 9325
- Status last verified
- Dec 2022
- First submitted
- 27 Mar 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Retrolaminar Block as Opioid Free Anesthesia and Enhanced Recovery After Posterior Lumber Spine Discectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05312866
- Acronym / sponsor ID
- 9325
- Conditions
- Opioid Free Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 6 Apr 2022 (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 intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain.
Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients
Detailed description
- Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
- Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard analgesia (paracetamol +fentanyl) | Active comparator | Procedure: Standard analgesia (paracetamol +fentanyl)Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv |
| Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone | Active comparator | Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasonePatients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent from the patient.
- Age: 21-60 years old.
- Sex: both sex (males and females).
- American Society of Anesthesiologist Physical status: ASA 1\& II.
- Body Mass Index (BMI) = (25-30 kg/m2).
Key exclusion criteria (6 listed)
- Altered mental state.
- Patients with known history of allergy to study drugs.
- Advanced hepatic, renal, cardiovascular, and respiratory diseases.
- Patients with chronic pain.
- Patients receiving anticoagulants.
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 |
|---|---|---|
| Standard analgesia (paracetamol +fentanyl)Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv | Procedure or surgery | Standard analgesia (paracetamol +fentanyl) |
| Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasonePatients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina. | Procedure or surgery | Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone |
Primary outcome
The recovery time
Time frame: up to 1 hour postoperative
The recovery time (time from discontinuation of isoflurane to first response to verbal command) will be recorded, then the patient will be transferred to the post anesthesia care unite (PACU) on standard monitors.
1 secondary outcome
pain intensity
Time frame: up to 24 hours postoperative
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 16 Dec 2022.
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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.
Alshaimaa Kamel, M.D principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard analgesia (paracetamol +fentanyl) and Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone in people with Opioid Free Anesthesia, run by Zagazig 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 6 inclusion and 6 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 16 Dec 2022. 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?
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?
The recovery time (time frame: up to 1 hour postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2022.