Lumbar Disc DiseasePhase 4ESBNCT05247021
Erector Spinae Plane Block in Spine Surgeries
A Phase 4 study testing erector spinae block for group E in people with Lumbar Disc Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim of this study was to assess the efficacy of erector spinae plane block (ESB) for postoperative pain management in lumbar spine surgery. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lumbar Disc Disease
- What is being tested?
- erector spinae block for group E
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2021to Jun 2022
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients American Society of Anesthesiologists physical status (ASA) I and II.
- Both sexes.
- Age between 20 to 60 years old.
- Scheduled for lumbar spine surgeries.
Who cannot join
- Patients who received long acting opioids preoperatively.
- Patients with bleeding disorders and coagulopathy.
- Infection at the injection site.
- Allergy to local anesthetics.
- Patients with significant cognitive dysfunction.
- Patients with diabetic neuropathy.
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- Patients with uncontrolled hypertension or diabetes.
- Patients with advanced cardiac, respiratory, hepatic or renal disease.
- Patients with viral hepatitis or HIV.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
amgad A hamdi, MSc, 01002400389 ext. +2, amgadhamdi@med.asu.edu.eg
amr g sayed, MD, 01005013194 ext. +2, dramrgaber7@gmail.com
About this study
Official title: Bilateral Ultrasound Guided Erector Spinae Plane Block for Postoperative Pain Management in Lumbar Spine Surgery ( a Controlled Study Trial)
Aim of this study was to assess the efficacy of erector spinae plane block (ESB) for postoperative pain management in lumbar spine surgery.
- Conditions
- Lumbar Disc Disease
- Being tested
- erector spinae block for group E
- Keywords
- erector spinae block, Lumbar disc surgery
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae block for group EProcedure or surgery
. The patient will be placed in the prone position. A high-frequency linear probe or a curved array probe, depending on the BMI of the patient, will be placed in longitudinal alignment, 2-3cm lateral to the vertebral column. The transverse processes of the vertebrae at the level of surgery, the erector spinae muscle, and the psoas muscle will be identified. A 5- or 8-cm 22-G ultrasound needle will be inserted with an in-plane technique in a cephalad-to-caudal direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20ml of bupivacaine 0.25% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side.
| Study group | Role | What they receive |
|---|---|---|
| erector spinae block group (E) | Experimental | patients will receive bilateral ultrasound guided erector spinae block before the lumbar spine surgery starts.(20ml of bupivacaine 0.25%) after receiving general anesthesia Receives: Procedure: erector spinae block for group E |
| control group (C) | No intervention | patients will receive standard general anesthesia for lumbar spine surgery according to hospital protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the postoperative 24 hours morphine consumption
the analgesic effect of erector spine block will be assessed postoperative by numeric rating scale (NRS), if NRS is more than 3 the patient will receive a rescue dose of 5 milligrams of morphine
Measured: 24 hours postoperative
Secondary outcomes (4)
Mean Blood pressure in mmHg
Measure mean blood pressure of patients postoperative every 4 hours
Measured: 24 hours postoperative
Heart rate
Measure heart of the patients postoperative every 4 hours
Measured: 24 hours postoperative
Patient satisfaction
Measure patient satisfaction by asking the patient if he is satisfied or not " yes or no"
Measured: 24 hours postoperative
First time of mobilization to a chair
Measure the time to first mobilization to a chair in minutes
Measured: 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 posted18 Feb 2022
- Study start22 Jan 2021
- Primary completion22 Apr 2022 (estimated)
- Study completionJun 2022 (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 Lumbar Disc DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ossama mansour, professor, Study chair, faculty of medicine , ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247021
- Sponsor's protocol ID
- ainshmas university
- Acronym
- ESB
- Status last verified
- Dec 2021
- First submitted
- 11 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.
PubMed 31033625
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Ultrasound Guided Erector Spinae Plane Block for Postoperative Pain Management in Lumbar Spine Surgery ( a Controlled Study Trial)
- ClinicalTrials.gov ID
- NCT05247021
- Acronym / sponsor ID
- ESB / ainshmas university
- Conditions
- Lumbar Disc Disease
- Keywords
- erector spinae block, Lumbar disc surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 22 Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 18 Feb 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.
Aim of this study was to assess the efficacy of erector spinae plane block (ESB) for postoperative pain management in lumbar spine 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 |
|---|---|---|
| erector spinae block group (E) | Experimental | Procedure: erector spinae block for group Epatients will receive bilateral ultrasound guided erector spinae block before the lumbar spine surgery starts.(20ml of bupivacaine 0.25%) after receiving general anesthesia |
| control group (C) | No intervention | –patients will receive standard general anesthesia for lumbar spine surgery according to hospital protocol. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients American Society of Anesthesiologists physical status (ASA) I and II.
- Both sexes.
- Age between 20 to 60 years old.
- Scheduled for lumbar spine surgeries.
Key exclusion criteria (9 listed)
- Patients who received long acting opioids preoperatively.
- Patients with bleeding disorders and coagulopathy.
- Infection at the injection site.
- Allergy to local anesthetics.
- Patients with significant cognitive dysfunction.
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 block for group E. The patient will be placed in the prone position. A high-frequency linear probe or a curved array probe, depending on the BMI of the patient, will be placed in longitudinal alignment, 2-3cm lateral to the vertebral column. The transverse processes of the vertebrae at the level of surgery, the erector spinae muscle, and the psoas muscle will be identified. A 5- or 8-cm 22-G ultrasound needle will be inserted with an in-plane technique in a cephalad-to-caudal direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20ml of bupivacaine 0.25% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side. | Procedure or surgery | erector spinae block group (E) |
Primary outcome
the postoperative 24 hours morphine consumption
Time frame: 24 hours postoperative
the analgesic effect of erector spine block will be assessed postoperative by numeric rating scale (NRS), if NRS is more than 3 the patient will receive a rescue dose of 5 milligrams of morphine
4 secondary outcomes
Mean Blood pressure in mmHg
Time frame: 24 hours postoperative
Heart rate
Time frame: 24 hours postoperative
Patient satisfaction
Time frame: 24 hours postoperative
First time of mobilization to a chair
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 31033625Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.
- 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.
ossama mansour, professor study chair
faculty of medicine , ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing erector spinae block for group E in people with Lumbar Disc Disease, 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 4 inclusion and 9 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 18 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 amgad A hamdi, MSc (01002400389 ext. +2, amgadhamdi@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the postoperative 24 hours morphine consumption (time frame: 24 hours postoperative). 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 NCT05247021, 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 18 Feb 2022.