Erector Spinae Plane BlockPainNCT06844747
Postoperative Pain in Lumbar Disc Surgery
A study testing erector spinae plane block(ESPB) in people with Erector Spinae Plane Block and Wound Infiltration, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study included 46 patients who underwent lumbar disc herniation surgery under general anesthesia. After the operation, US-guided ESPB was performed on Group E, and WI was performed on Group W. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Erector Spinae Plane Block, Wound Infiltration, Lumbar Disc Herniation
- What is being tested?
- erector spinae plane block(ESPB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 29 Aug 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anesthesiologists (ASA) physical status I-II
Who cannot join
- Patients with recurrent lumbar disc herniation,
- Obesity (body mass index >35 kg/m2),
- Infection in the surgical site,
- Known local anesthetic drug allergy,
- Chronic pain, and coagulation disorders were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr Lutfi Kirdar City Hospital
Istanbul, 34865
About this study
Official title: Comparison of the Ultrasound-guided Erector Spinae Plane Block and Wound Infiltration for Postoperative Pain Management in Lumbar Disc Surgery
This study included 46 patients who underwent lumbar disc herniation surgery under general anesthesia. After the operation, US-guided ESPB was performed on Group E, and WI was performed on Group W. Postoperative pain was assessed, and the time to first analgesic requirement, total analgesic amount in 24 hours, and side effects were recorded. IBM SPSS Statistics 22 was used for statistical analyses.
- Conditions
- Erector Spinae Plane Block, Wound Infiltration, Lumbar Disc Herniation, Postoperative Pain
- Being tested
- erector spinae plane block(ESPB)
- Medical subject headings
- Intervertebral Disc Displacement, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane block(ESPB)Other
Also called wound infiltration
ESPB group received US-guided plane block, WI group received local anaesthetic wound infiltration
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane block | Active comparator | At the end of the surgery, while the patient was still intubated and in the prone position, the linear probe of a Samsung HM70 EVO ultrasound device was placed sagittally, approximately 2-3 cm lateral to the spinal cord. After identifying the erector spinae muscle and transverse processes, a 22-G, 10-mm block needle (Braun Stimuplex Ultra 360, Germany) was advanced posterior to the transverse process after reaching the bone structure. The location of the needle tip was then confirmed, 0.25% bupivacaine (20mL) was injected intermittently, and separation of the erector spinae muscle from the transverse process was observed. The procedure was applied bilaterally (22 patients) Receives: Other: erector spinae plane block(ESPB) |
| wound infiltration | Active comparator | In Group W, a dose of 0.5% bupivacaine (20 ml) was injected for wound infiltration into the surgery site. (24 patients) Receives: Other: erector spinae plane block(ESPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
US-guided ESPB and WI on postoperative pain
Postoperative pain assessment was conducted in the recovery unit using the Numeric Rating Scale (NRS) with a scale of 0 (no pain) to 10 (worst pain imaginable). Standard postoperative intravenous analgesia included 75 mg of diclofenac sodium administered every 8 hours. In cases where NRS was ≥4, rescue analgesia was provided with 100 mg of intravenous tramadol. Anesthesia duration, surgical duration, NRS scores at postoperative 1 hour, 3 hours, 12 hours, and 24 hours, time to first analgesic, and total analgesic requirement in the first 24 hours were recorded. All side effects (hypotension, bradycardia, etc.) were documented.
Measured: postoperative 1 hour, 3 hours, 12 hours, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Jun 2023
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design was double-blind, prospective, randomized, and controlled, involving patients undergoing elective lumbar disc herniation surgery.The patients were randomized into two groups, the ESPB group (Group E) and the WI group (Group W), with 25 patients in each group, using a computer system. ESPB or WI was administered to the patients according to the randomization before awakening after the operation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İrem DURMUS, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Irem DURMUS MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844747
- Sponsor's protocol ID
- 2023/514/250/34
- Acronym
- Pain
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 25 Feb 2025
- 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ultrasound-guided Erector Spinae Plane Block and Wound Infiltration for Postoperative Pain Management in Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT06844747
- Acronym / sponsor ID
- Pain / 2023/514/250/34
- Conditions
- Erector Spinae Plane Block, Wound Infiltration, Lumbar Disc Herniation, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 25 Feb 2025 (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.
This study included 46 patients who underwent lumbar disc herniation surgery under general anesthesia. After the operation, US-guided ESPB was performed on Group E, and WI was performed on Group W. Postoperative pain was assessed, and the time to first analgesic requirement, total analgesic amount in 24 hours, and side effects were recorded. IBM SPSS Statistics 22 was used for statistical analyses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study design was double-blind, prospective, randomized, and controlled, involving patients undergoing elective lumbar disc herniation surgery.The patients were randomized into two groups, the ESPB group (Group E) and the WI group (Group W), with 25 patients in each group, using a computer system. ESPB or WI was administered to the patients according to the randomization before awakening after the operation.
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane block | Active comparator | Other: erector spinae plane block(ESPB)At the end of the surgery, while the patient was still intubated and in the prone position, the linear probe of a Samsung HM70 EVO ultrasound device was placed sagittally, approximately 2-3 cm lateral to the spinal cord. After identifying the erector spinae muscle and transverse processes, a 22-G, 10-mm block needle (Braun Stimuplex Ultra 360, Germany) was advanced posterior to the transverse process after reaching the bone structure. The location of the needle tip was then confirmed, 0.25% bupivacaine (20mL) was injected intermittently, and separation of the erector spinae muscle from the transverse process was observed. The procedure was applied bilaterally (22 patients) |
| wound infiltration | Active comparator | Other: erector spinae plane block(ESPB)In Group W, a dose of 0.5% bupivacaine (20 ml) was injected for wound infiltration into the surgery site. (24 patients) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesiologists (ASA) physical status I-II
Key exclusion criteria (5 listed)
- Patients with recurrent lumbar disc herniation,
- Obesity (body mass index >35 kg/m2),
- Infection in the surgical site,
- Known local anesthetic drug allergy,
- Chronic pain, and coagulation disorders were excluded.
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 block(ESPB)Also: wound infiltrationESPB group received US-guided plane block, WI group received local anaesthetic wound infiltration | Other | erector spinae plane block, wound infiltration |
Primary outcome
US-guided ESPB and WI on postoperative pain
Time frame: postoperative 1 hour, 3 hours, 12 hours, and 24 hours
Postoperative pain assessment was conducted in the recovery unit using the Numeric Rating Scale (NRS) with a scale of 0 (no pain) to 10 (worst pain imaginable). Standard postoperative intravenous analgesia included 75 mg of diclofenac sodium administered every 8 hours. In cases where NRS was ≥4, rescue analgesia was provided with 100 mg of intravenous tramadol. Anesthesia duration, surgical duration, NRS scores at postoperative 1 hour, 3 hours, 12 hours, and 24 hours, time to first analgesic, and total analgesic requirement in the first 24 hours were recorded. All side effects (hypotension, bradycardia, etc.) were documented.
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 25 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Erector Spinae Plane Block
Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
Postoperative Pain
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain
Active, not recruiting
Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery
Analgesia
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.
Irem DURMUS MD principal investigator
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(ESPB) in people with Erector Spinae Plane Block and Wound Infiltration, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 25 Feb 2025. 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 Turkey (Türkiye). 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?
US-guided ESPB and WI on postoperative pain (time frame: postoperative 1 hour, 3 hours, 12 hours, and 24 hours). 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 25 Feb 2025.