PainNCT06257953
The Effects of Body Mass Index on Erector Spinae Plane Block Analgesia
An observational study of Pain and Pain Postoperative, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In recent years, obesity has become one of the leading health problems worldwide. It is known that obesity can cause various diseases and negatively impact the quality of life. Therefore, many conditions believed to be affected by obesity and relevant to patients\' quality of life have been scientifically… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Pain Postoperative, Pain Acute
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 26 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This prospective study includes adult patients aged 18 to 65 years with ASA physical status I-III who are scheduled to undergo elective LDH surgery under standardized general anesthesia and bilateral ESPB for postoperative analgesia at Ankara Etlik City Hospital. All participants meet predefined inclusion and exclusion criteria. Patients are categorized into three groups according to their preoperative BMI: 18-24.9 kg/m², 25-29.9 kg/m², and 30-40 kg/m². The study population represents consecutive eligible surgical patients during the study period. No experimental intervention beyond routine anesthetic and analgesic management is introduced; BMI serves as the exposure variable for comparative analysis of analgesic outcomes.
Who may be able to join
- 18 to 65 years old
- ASA physical status I-II-III
- BMI 18 to 40 kg/m²
- Elective LDH surgery
Who cannot join
- Patient refusing the procedure
- Patients who have previously undergone spinal surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo LDH surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
About this study
Official title: The Effects of Body Mass Index on Erector Spina Plane Block Analgesia Treatment in Lumbar Disc Herniation Surgery
In recent years, obesity has become one of the leading health problems worldwide. It is known that obesity can cause various diseases and negatively impact the quality of life. Therefore, many conditions believed to be affected by obesity and relevant to patients\' quality of life have been scientifically investigated and continue to be researched. One of these conditions is postoperative pain, with studies in the literature indicating that postoperative pain levels increase in parallel with each unit increase in BMI.
The incidence of lumbar disc herniation (LDH) is on the rise and adversely affecting the quality of life. The primary surgical intervention for LDH is discectomy. In recent years, various less invasive techniques, such as microdiscectomy, have been described to improve both surgical and analgesic outcomes. However, even with microdiscectomy surgery, postoperative pain may occur, and its control should be well-managed. Inadequate pain control can lead to unwanted effects of postoperative pain. Regional analgesia techniques may be preferred for effective analgesic treatment after spinal surgery. Methods such as paravertebral block, erector spinae plane block (ESPB), thoracolumbar interfascial plane block are widely used for analgesia in spinal surgery. The effectiveness of these regional techniques may vary depending on various factors, one of which is BMI.
The hypothesis in this study is that as BMI increases, the level of pain in patients may also increase. As a result, this study aims to investigate the relationship between BMI and postoperative pain levels in patients undergoing standard LDH surgery, anesthesia, and analgesia.
- Conditions
- Pain, Pain Postoperative, Pain Acute, Erector Spinae Plane Block, Lumbar Disc Herniation, Body Mass Index
- Being tested
- Erector spinae plane block
- Medical subject headings
- Pain, Pain, Postoperative, Acute Pain, Intervertebral Disc Displacement
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
Erector spinae plane block will be applied to the patients under real-time ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a BMI of 18-24.9 kg/m2 | Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml of 0.25% bupivacaine was injected into the area. Then the block process will be applied to the other side in the same way. A total of 30 ml of 15 ml 0.25% bupivacaine will be injected. Receives: Procedure: Erector spinae plane block | |
| Patients with a BMI of 25-29.9 kg/m2 | Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml of 0.25% bupivacaine was injected into the area. Then the block process will be applied to the other side in the same way. A total of 30 ml of 15 ml 0.25% bupivacaine will be injected. Receives: Procedure: Erector spinae plane block | |
| Patients with a BMI of 30-40 kg/m2 | Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml of 0.25% bupivacaine was injected into the area. Then the block process will be applied to the other side in the same way. A total of 30 ml of 15 ml 0.25% bupivacaine will be injected. Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st hour after surgery.
Measured: 1st hour after surgery.
Secondary outcomes (5)
Pain Scores
Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 2nd hour after surgery.
Pain Scores
Pain will be assessed at the 6th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 6th hour after surgery.
Pain Scores
Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 12th hour after surgery.
Pain Scores
Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 24th hour after surgery.
Intraoperative remifentanil consumption
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.
Measured: During the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start10 Jan 2024
- Primary completion10 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257953
- Sponsor's protocol ID
- AEŞH-BADEK-2024-035
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2024
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Body Mass Index on Erector Spina Plane Block Analgesia Treatment in Lumbar Disc Herniation Surgery
- ClinicalTrials.gov ID
- NCT06257953
- Acronym / sponsor ID
- AEŞH-BADEK-2024-035
- Conditions
- Pain, Pain Postoperative, Pain Acute, Erector Spinae Plane Block, Lumbar Disc Herniation, Body Mass Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 14 Feb 2024 (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.
In recent years, obesity has become one of the leading health problems worldwide. It is known that obesity can cause various diseases and negatively impact the quality of life. Therefore, many conditions believed to be affected by obesity and relevant to patients\' quality of life have been scientifically investigated and continue to be researched. One of these conditions is postoperative pain, with studies in the literature indicating that postoperative pain levels increase in parallel with each unit increase in BMI.
The incidence of lumbar disc herniation (LDH) is on the rise and adversely affecting the quality of life. The primary surgical intervention for LDH is discectomy. In recent years, various less invasive techniques, such as microdiscectomy, have been described to improve both surgical and analgesic outcomes. However, even with microdiscectomy surgery, postoperative pain may occur, and its control should be well-managed. Inadequate pain control can lead to unwanted effects of postoperative pain. Regional analgesia techniques may be preferred for effective analgesic treatment after spinal surgery. Methods such as paravertebral block, erector spinae plane block (ESPB), thoracolumbar interfascial plane block are widely used for analgesia in spinal surgery. The effectiveness of these regional techniques may vary depending on various factors, one of which is BMI.
The hypothesis in this study is that as BMI increases, the level of pain in patients may also increase. As a result, this study aims to investigate the relationship between BMI and postoperative pain levels in patients undergoing standard LDH surgery, anesthesia, and analgesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with a BMI of 18-24.9 kg/m2 | – | Procedure: Erector spinae plane blockFollowing the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml of 0.25% bupivacaine was injected into the area. Then the block process will be applied to the other side in the same way. A total of 30 ml of 15 ml 0.25% bupivacaine will be injected. |
| Patients with a BMI of 25-29.9 kg/m2 | – | Procedure: Erector spinae plane blockFollowing the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml of 0.25% bupivacaine was injected into the area. Then the block process will be applied to the other side in the same way. A total of 30 ml of 15 ml 0.25% bupivacaine will be injected. |
| Patients with a BMI of 30-40 kg/m2 | – | Procedure: Erector spinae plane blockFollowing the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml of 0.25% bupivacaine was injected into the area. Then the block process will be applied to the other side in the same way. A total of 30 ml of 15 ml 0.25% bupivacaine will be injected. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective study includes adult patients aged 18 to 65 years with ASA physical status I-III who are scheduled to undergo elective LDH surgery under standardized general anesthesia and bilateral ESPB for postoperative analgesia at Ankara Etlik City Hospital. All participants meet predefined inclusion and exclusion criteria. Patients are categorized into three groups according to their preoperative BMI: 18-24.9 kg/m², 25-29.9 kg/m², and 30-40 kg/m². The study population represents consecutive eligible surgical patients during the study period. No experimental intervention beyond routine anesthetic and analgesic management is introduced; BMI serves as the exposure variable for comparative analysis of analgesic outcomes.
Key inclusion criteria (4 listed)
- 18 to 65 years old
- ASA physical status I-II-III
- BMI 18 to 40 kg/m²
- Elective LDH surgery
Key exclusion criteria (5 listed)
- Patient refusing the procedure
- Patients who have previously undergone spinal surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo LDH surgery
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 blockErector spinae plane block will be applied to the patients under real-time ultrasound guidance. | Procedure or surgery | Patients with a BMI of 18-24.9 kg/m2, Patients with a BMI of 25-29.9 kg/m2, Patients with a BMI of 30-40 kg/m2 |
Primary outcome
Pain Scores
Time frame: 1st hour after surgery.
Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st hour after surgery.
5 secondary outcomes
Pain Scores
Time frame: 2nd hour after surgery.
Pain Scores
Time frame: 6th hour after surgery.
Pain Scores
Time frame: 12th hour after surgery.
Pain Scores
Time frame: 24th hour after surgery.
Intraoperative remifentanil consumption
Time frame: During the intraoperative period
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 27 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Pain Postoperative, run by Atatürk Chest Diseases and Chest Surgery 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 4 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 27 Feb 2026. 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?
Pain Scores (time frame: 1st hour after surgery.). 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 27 Feb 2026.