Postoperative PainNCT06157762
Open Technique Erector Spinae Plane Block in Spinal Surgery
A study testing Erector spinae plane block and Erector spinae plane block performed by surgeon in people with Postoperative Pain and Erector Spinae Plane Block in Spinal Surgery, run by Kahramanmaras Sutcu Imam University.
Trial summary
Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles.ESPB has been successfully applied as a part of multimodal analgesia in treating postoperative pain in spinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Erector Spinae Plane Block in Spinal Surgery
- What is being tested?
- Erector spinae plane block and Erector spinae plane block performed by surgeon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Oct 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III patients
- Agreed to participate in the study
Who cannot join
- Patients with infection at the injection site
- Coagulopathy Allergy to amide-type local anesthetics
- History of peripheral neuropathy
- Hepatic and/or renal failure
- Refusing the procedure
- Patients with heart disease
- Patients who have previously undergone surgery from the same area
About this study
Official title: Comparison of the Effectiveness of Preoperative Ultrasound-Guided Erector Spine Plane Block and Erector Spine Plane Block Performed by the Intraoperative Surgeon in Postoperative Analgesia in Patients Undergoing Lumbar Disc Herniation Surgery
Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles.ESPB has been successfully applied as a part of multimodal analgesia in treating postoperative pain in spinal surgery. However, it may be difficult or impossible to perform lumbar ESPB in obese patients or cases of increased lumbar lordosis. This study aims to investigate the effectiveness of ESPB applied by the intraoperative surgeon.
- Being tested
- Erector spinae plane block, Erector spinae plane block performed by surgeon
- Keywords
- Pain, postoperative analgesia, Erector spinae plane block, Spinal surgery, Open Technique
- Medical subject headings
- Pain, Postoperative, Pain
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
ultrasound guided lumbar erector spinae plane block
Erector spinae plane block performed by surgeonProcedure or surgery
Erector spinae plane block performed by surgeon
| Study group | Role | What they receive |
|---|---|---|
| ESPB performed by surgeon | Experimental | The transverse process of the vertebra will be observed by the surgeon intraoperatively. Local anesthetic medication will be applied between the transverse process and the ESP muscle group. Receives: Procedure: Erector spinae plane block performed by surgeon |
| Erector spinae plane block | Active comparator | The ultrasound-guided erector spinae plane block will be applied preoperatively. Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
Measured: up to 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Care provider, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökçe Gişi, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157762
- Sponsor's protocol ID
- 2022/26-05
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Preoperative Ultrasound-Guided Erector Spine Plane Block and Erector Spine Plane Block Performed by the Intraoperative Surgeon in Postoperative Analgesia in Patients Undergoing Lumbar Disc Herniation Surgery
- ClinicalTrials.gov ID
- NCT06157762
- Acronym / sponsor ID
- 2022/26-05
- Keywords
- Pain, postoperative analgesia, Erector spinae plane block, Spinal surgery, Open Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 6 Dec 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.
Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles.ESPB has been successfully applied as a part of multimodal analgesia in treating postoperative pain in spinal surgery. However, it may be difficult or impossible to perform lumbar ESPB in obese patients or cases of increased lumbar lordosis. This study aims to investigate the effectiveness of ESPB applied by the intraoperative surgeon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB performed by surgeon | Experimental | Procedure: Erector spinae plane block performed by surgeonThe transverse process of the vertebra will be observed by the surgeon intraoperatively. Local anesthetic medication will be applied between the transverse process and the ESP muscle group. |
| Erector spinae plane block | Active comparator | Procedure: Erector spinae plane blockThe ultrasound-guided erector spinae plane block will be applied preoperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III patients
- Agreed to participate in the study
Key exclusion criteria (7 listed)
- Patients with infection at the injection site
- Coagulopathy Allergy to amide-type local anesthetics
- History of peripheral neuropathy
- Hepatic and/or renal failure
- Refusing the procedure
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 blockultrasound guided lumbar erector spinae plane block | Procedure or surgery | Erector spinae plane block |
| Erector spinae plane block performed by surgeonErector spinae plane block performed by surgeon | Procedure or surgery | ESPB performed by surgeon |
Primary outcome
opioid consumption
Time frame: up to 24 hour
The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and Erector spinae plane block performed by surgeon in people with Postoperative Pain and Erector Spinae Plane Block in Spinal Surgery, run by Kahramanmaras Sutcu Imam University.
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 2 inclusion and 7 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
opioid consumption (time frame: up to 24 hour). 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 6 Dec 2023.