Anaesthetic Drugs, Hypotensive Drugs, Perioperative AnalgesiaUS ESP blockNCT04302129
Ultrasound Guided Erector Spinae Plane Block Combined With General Anaesthesia Versus Conventional General Anaesthesia in Lumbar Spine Surgery
A study testing Erector spinae plane block and Multimodal analgesia in people with Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia, run by Mohamed Elsayed at 1 site in Egypt.
Trial summary
Ultrasound guided erector spinae plain block combined with general anaesthesia versus conventional general anaesthesia in lumbar spine surgery, it's hypothesized that combined regional anaesthesia with general anaesthesia in lumbar spine surgery may reduce the anaesthetic requirements, aid in controlled hypotension… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia
- What is being tested?
- Erector spinae plane block and Multimodal analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jan 2020to Apr 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing lumbar spine surgery
Who cannot join
- Coagulation disorders.
- BMI > 30 or < 18.5.
- Patients with surgical site infection.
- Patients with unstable spine integrity like fractures or scoliosis.
- Hypertensive ,cardiac and diabetic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ERECTOR SPINAE PLANE BLOCK COMBINED WITH GENERAL ANAESTHESIA VERSUS CONVENTIONAL GENERAL ANAESTHESIA IN LUMBAR SPINE SURGERY
Ultrasound guided erector spinae plain block combined with general anaesthesia versus conventional general anaesthesia in lumbar spine surgery, it's hypothesized that combined regional anaesthesia with general anaesthesia in lumbar spine surgery may reduce the anaesthetic requirements, aid in controlled hypotension and improve the perioperative pain management.
Read the detailed description
Primary outcomes:
- Anaesthetic requirements: based on entropy monitoring(state and response entropy monitoring and the difference as a measure for adequacy of analgesia) and haemodynamic parameters ( heart rate and mean arterial blood pressure) at the following time intervals: before induction, after induction, after giving either ESP block or multimodal analgesia and starting surgical stimulus, at 30 min intervals, at end of anaesthesia, at eye opening.
Secondary outcomes:
- Stress response measurement based on serum cortisol and blood glucose levels
- Controlled hypotensive anaesthesia: various drugs required and doses given
- Intraoperative and postoperative analgesia.
- Postanaesthesia care unit data concerning recovery.
- Being tested
- Erector spinae plane block, Multimodal analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
20 ml local anaesthetic are injected bilaterally on each side of the surgical incision underneath the erector spinae muscle where the dorsal rami pass around the bases of the transverse processes.
Multimodal analgesiaDrug
Ketorolac 0.75 mg/ Kg and paracetamol 10 mg/ Kg intravenously
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided erector spinae block and general anaesthesia | Experimental | Ultrasound guided erector spine plane block is done after general anaesthesia and prone positioning Receives: Procedure: Erector spinae plane block |
| Multimodal analgesia with general anaesthesia | Active comparator | Multimodal analgesia given with general anaesthesia in form of ketorolac and paracetamol Receives: Drug: Multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaesthetic requirements:
based on entropy monitoring and haemodynamic parameters.
Measured: the surgery period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start4 Jan 2020
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaesthetic Drugs, Hypotensive Drugs, Perioperative AnalgesiaStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Elsayed
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alexandria
- Responsible party
- Sponsor-investigator, Mohamed Elsayed, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302129
- Sponsor's protocol ID
- operative lumbar spine pain
- Acronym
- US ESP block
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERECTOR SPINAE PLANE BLOCK COMBINED WITH GENERAL ANAESTHESIA VERSUS CONVENTIONAL GENERAL ANAESTHESIA IN LUMBAR SPINE SURGERY
- ClinicalTrials.gov ID
- NCT04302129
- Acronym / sponsor ID
- US ESP block / operative lumbar spine pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mohamed ElsayedUniversity, hospital or other
- Collaborators
- University of Alexandria
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 10 Mar 2020 (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.
Ultrasound guided erector spinae plain block combined with general anaesthesia versus conventional general anaesthesia in lumbar spine surgery, it's hypothesized that combined regional anaesthesia with general anaesthesia in lumbar spine surgery may reduce the anaesthetic requirements, aid in controlled hypotension and improve the perioperative pain management.
Detailed description
Primary outcomes:
- Anaesthetic requirements: based on entropy monitoring(state and response entropy monitoring and the difference as a measure for adequacy of analgesia) and haemodynamic parameters ( heart rate and mean arterial blood pressure) at the following time intervals: before induction, after induction, after giving either ESP block or multimodal analgesia and starting surgical stimulus, at 30 min intervals, at end of anaesthesia, at eye opening.
Secondary outcomes:
- Stress response measurement based on serum cortisol and blood glucose levels
- Controlled hypotensive anaesthesia: various drugs required and doses given
- Intraoperative and postoperative analgesia.
- Postanaesthesia care unit data concerning recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided erector spinae block and general anaesthesia | Experimental | Procedure: Erector spinae plane blockUltrasound guided erector spine plane block is done after general anaesthesia and prone positioning |
| Multimodal analgesia with general anaesthesia | Active comparator | Drug: Multimodal analgesiaMultimodal analgesia given with general anaesthesia in form of ketorolac and paracetamol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing lumbar spine surgery
Key exclusion criteria (5 listed)
- Coagulation disorders.
- BMI > 30 or < 18.5.
- Patients with surgical site infection.
- Patients with unstable spine integrity like fractures or scoliosis.
- Hypertensive ,cardiac and diabetic patients.
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 |
|---|---|---|
| Erector spinae plane block20 ml local anaesthetic are injected bilaterally on each side of the surgical incision underneath the erector spinae muscle where the dorsal rami pass around the bases of the transverse processes. | Procedure or surgery | ultrasound guided erector spinae block and general anaesthesia |
| Multimodal analgesiaKetorolac 0.75 mg/ Kg and paracetamol 10 mg/ Kg intravenously | Drug | Multimodal analgesia with general anaesthesia |
Primary outcome
Anaesthetic requirements:
Time frame: the surgery period
based on entropy monitoring and haemodynamic parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and Multimodal analgesia in people with Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia, run by Mohamed Elsayed 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 5 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 17 Mar 2020. 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?
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?
Anaesthetic requirements: (time frame: the surgery period). 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 17 Mar 2020.