Lumbar Disc HerniationNCT05447780
Comparing General Anesthesia, General Anesthesia With ESP Block or TLIP Block in Patients Undergoing Lumbar Surgeries
A study testing regional anesthesia in people with Lumbar Disc Herniation and Lumbar Discogenic Pain, run by Anesthesia Research Group UA at 1 site in Ukraine.
Trial summary
The regional methods of anesthesia for the neurosurgical operations of the spine and spinal cord reducing the needs for opioids intra operatively and reducing pain in the postoperative period, decrease the numbers of failed back syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Discogenic Pain, Lumbar Spinal Stenosis
- What is being tested?
- regional anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUkraine
- Study dates
- 18 Apr 2022to 18 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- back surgery
Who cannot join
- contraindications to the regional method of analgesia,
- patient refusal,
- patients with diabetes mellitus
- mental illness
- pregnancy
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
Anesthesia department Medical Network Dobrobut
Kyiv, 01000
Yelyzaveta Plechysta, MD, +380636494490, plechysta.y@dobrobut.ua
Terentev Oleksandr, MD, +380973875200
About this study
Official title: Comparing the General Anesthesia, the General Anesthesia With the ESP Block or TLIP Block in the Patients Undergoing Lumbar Surgeries
The regional methods of anesthesia for the neurosurgical operations of the spine and spinal cord reducing the needs for opioids intra operatively and reducing pain in the postoperative period, decrease the numbers of failed back syndrome.
- Conditions
- Lumbar Disc Herniation, Lumbar Discogenic Pain, Lumbar Spinal Stenosis, Failed Back Surgery Syndrome
- Being tested
- regional anesthesia
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis, Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anesthesiaProcedure or surgery
regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Experimental | induction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg maintenance anesthesia: sevoflurane, doses of the inhalation agent according to bispectral index (BIS) monitor ( target BIS level 40-60) and fentanyl 1-5 mcg\kg\h. Receives: Procedure: regional anesthesia |
| Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block) | Experimental | induction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg ESP- block with US control with single shot of local anesthetic ( bupivacaine 0.375% or 0.25% 20-30 ml) is performed after induction.
maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\kg\h. Receives: Procedure: regional anesthesia |
| Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block) | Experimental | induction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg TLIP- block with US control with single shot of local anesthetic ( bupivacaine 0.25% 15 ml or mixed bupivacaine 0.25% 7.5 ml and lidocaine 2% 7.5 ml) is performed after induction.
maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\kg\h. Receives: Procedure: regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Measured: 2 hours after surgery
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Measured: 6 hours after surgery
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Measured: 24 hour after surgery
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Measured: 48 hour after surgery
Secondary outcomes (2)
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Measured: 1 month after surgery
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Measured: 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start18 Apr 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion18 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anesthesia Research Group UA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Plechysta Yelyzaveta, Anesthesia Research Group UA
- Investigators
- Yelyzaveta Plechystaya, MD, Study chair, chief of the anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447780
- Sponsor's protocol ID
- 1718042022
- Status last verified
- Mar 2024
- First submitted
- 17 Jun 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the General Anesthesia, the General Anesthesia With the ESP Block or TLIP Block in the Patients Undergoing Lumbar Surgeries
- ClinicalTrials.gov ID
- NCT05447780
- Acronym / sponsor ID
- 1718042022
- Conditions
- Lumbar Disc Herniation, Lumbar Discogenic Pain, Lumbar Spinal Stenosis, Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Anesthesia Research Group UAUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 18 Dec 2025 (estimated)
- First posted
- 7 Jul 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.
The regional methods of anesthesia for the neurosurgical operations of the spine and spinal cord reducing the needs for opioids intra operatively and reducing pain in the postoperative period, decrease the numbers of failed back syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Experimental | Procedure: regional anesthesiainduction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg maintenance anesthesia: sevoflurane, doses of the inhalation agent according to bispectral index (BIS) monitor ( target BIS level 40-60) and fentanyl 1-5 mcg\kg\h. |
| Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block) | Experimental | Procedure: regional anesthesiainduction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg ESP- block with US control with single shot of local anesthetic ( bupivacaine 0.375% or 0.25% 20-30 ml) is performed after induction. maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\kg\h. |
| Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block) | Experimental | Procedure: regional anesthesiainduction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg TLIP- block with US control with single shot of local anesthetic ( bupivacaine 0.25% 15 ml or mixed bupivacaine 0.25% 7.5 ml and lidocaine 2% 7.5 ml) is performed after induction. maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\kg\h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- back surgery
Key exclusion criteria (5 listed)
- contraindications to the regional method of analgesia,
- patient refusal,
- patients with diabetes mellitus
- mental illness
- pregnancy
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 |
|---|---|---|
| regional anesthesiaregional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery | Procedure or surgery | Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block), Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block), General anesthesia |
Primary outcome
A Visual Analogue Scale (numerical rating scale (NRS)
Time frame: 2 hours after surgery
minimum 0 ( no pain), maximum 10 (the worst pain ever)
A Visual Analogue Scale (numerical rating scale (NRS)
Time frame: 6 hours after surgery
minimum 0 ( no pain), maximum 10 (the worst pain ever)
A Visual Analogue Scale (numerical rating scale (NRS)
Time frame: 24 hour after surgery
minimum 0 ( no pain), maximum 10 (the worst pain ever)
A Visual Analogue Scale (numerical rating scale (NRS)
Time frame: 48 hour after surgery
minimum 0 ( no pain), maximum 10 (the worst pain ever)
2 secondary outcomes
A Visual Analogue Scale (numerical rating scale (NRS)
Time frame: 1 month after surgery
A Visual Analogue Scale (numerical rating scale (NRS)
Time frame: 3 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- 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.
Yelyzaveta Plechystaya, MD study chair
chief of the anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional anesthesia in people with Lumbar Disc Herniation and Lumbar Discogenic Pain, run by Anesthesia Research Group UA at 1 site in Ukraine.
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 18 Mar 2024. 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 Ukraine. 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 Yelyzaveta Plechysta, MD (+380636494490, plechysta.y@dobrobut.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Visual Analogue Scale (numerical rating scale (NRS) (time frame: 2 hours after surgery). The study lists 4 primary outcomes in all. 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 18 Mar 2024.