Nerve BlockNCT07346599
A Block Method for Pain After Back Surgery
A study testing ESP block group in people with Nerve Block and Postoperative Pain, run by Kutahya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is to evaluate whether bilateral lumbar erector spinae plane (ESP) block can reduce postoperative pain in adult patients undergoing lumbar spine surgery. The study also assesses the safety of this method and its effects on the recovery process. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Block, Postoperative Pain, Randomised Clinical Trial
- What is being tested?
- ESP block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2021to 20 May 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over, 80 and under
- American Society of Anesthesiologists Patient Classification Score (ASA) between I and Ⅲ
- Patients who can cooperate and give consent
- No chronic analgesic or opioid use
- No mental or psychiatric disorders
- No alcohol or illicit drug use
- Patients scheduled for elective spinal surgery
Who cannot join
- -Patients who withdrew from participation at any time during the study
- Foreign nationals who could not be contacted
- Patients under 18 and over 80
- Patients with an ASA score of Ⅳ or higher
- Patients scheduled for emergency surgery
- Pregnant women and breastfeeding mothers
Show all 11Show fewer
- Bleeding diathesis
- Drug allergy
- Anticoagulant use
- Local/systemic infection
- Serious arrhythmia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Hospital
Afyonkarahisar, Merkez, 03000
About this study
Official title: The Effect of Bilateral Lumbar Erector Spinae Plane Block on Postoperative Analgesia in Lumbar Spinal Surgery
The purpose of this clinical trial is to evaluate whether bilateral lumbar erector spinae plane (ESP) block can reduce postoperative pain in adult patients undergoing lumbar spine surgery. The study also assesses the safety of this method and its effects on the recovery process. The main questions it aims to answer are:
Do patients who receive the ESP block experience less postoperative pain? Do these patients require fewer opioid (morphine-derived) analgesics? Does the first analgesic requirement occur later? Do patients mobilize earlier (stand/walk sooner)? Does the ESP block affect hemodynamic stability during and after surgery? Researchers will compare the ESP block group with the standard analgesia group to determine whether these effects occur.
Read more
Participants:
Patients in this study will be asked to:
Be randomly assigned to one of two groups before lumbar spine surgery Receive either a bilateral ESP block or standard analgesic therapy
Undergo postoperative follow-up including:
measurement of pain scores, recording of analgesic consumption, assessment of time to first analgesic requirement, monitoring of mobilization time, valuation of possible side effects
Read the detailed description
This randomized controlled study was designed to evaluate the effect of bilateral lumbar erector spinae plane (ESP) block on postoperative analgesia in patients undergoing lumbar spine surgery. A total of 102 patients scheduled for lumbar spine surgery were enrolled in the study and randomly assigned into two groups. One group received a bilateral ESP block at the L2-L4 levels using 20 mL of 0.25% bupivacaine on each side, while the control group received standard postoperative analgesia.
Postoperative pain assessment, opioid consumption, time to first analgesic request, mobilization time, intraoperative hemodynamic parameters, and the occurrence of adverse events were prospectively recorded according to a predefined follow-up protocol. The study was conducted using a prospective, randomized design to assess the efficacy and safety of bilateral lumbar ESP block for postoperative pain management in lumbar spine surgery.
- Conditions
- Nerve Block, Postoperative Pain, Randomised Clinical Trial
- Being tested
- ESP block group
- Keywords
- POSTOPERATİVE PAİN, ERECTOR SPİNA PLANE BLOCK, LUMBAR SPİNAL SURGERY
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP block groupProcedure or surgery
BILATERAL TWO-LEVEL ESP BLOCK WAS APPLIED TO PATIENTS UNDERGOING LUMBAR SPINAL SURGERY.
| Study group | Role | What they receive |
|---|---|---|
| ESP BLOCK, | Active comparator | Not described Receives: Procedure: ESP block group |
| CONTROL GROUP | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS values of patients in the first 24 hours postoperatively
Zero indicates no pain, and 10 indicates the worst possible pain
Measured: The first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start27 Sep 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nerve 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE KAYNAK, Afyonkarahisar Health Sciences University
- Investigators
- merve kaynak, Principal investigator, Kütahya City HospitalAli Kaynak, Study chair, Kütahya City Hospitalbilal a bezen, Study chair, Afyonkarahisar Health Sciences Universityremziye sıvacı, Study director, Afyonkarahisar Health Sciences Universityelif d bakı, Study chair, Afyonkarahisar Health Sciences Universityserhat yıldızhan, Study chair, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346599
- Sponsor's protocol ID
- 448
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Goel VK, Chandramohan M, Murugan C, Shetty AP, Subramanian B, Kanna RM, Rajasekaran S. Clinical efficacy of ultrasound guided bilateral erector spinae block for single-level lumbar fusion surgery: a prospective, randomized, case-control study. Spine J. 2021 Nov;21(11):1873-1880. doi: 10.1016/j.spinee.2021.06.015. Epub 2021 Jun 23.
PubMed 34171466Tseng V, Xu JL. Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: Is There a Better Option? J Neurosurg Anesthesiol. 2021 Jan;33(1):92. doi: 10.1097/ANA.0000000000000631. No abstract available.
PubMed 31343504Liu H, Zhu J, Wen J, Fu Q. Ultrasound-guided erector spinae plane block for postoperative short-term outcomes in lumbar spine surgery: A meta-analysis and systematic review. Medicine (Baltimore). 2023 Feb 17;102(7):e32981. doi: 10.1097/MD.0000000000032981.
PubMed 36800574
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bilateral Lumbar Erector Spinae Plane Block on Postoperative Analgesia in Lumbar Spinal Surgery
- ClinicalTrials.gov ID
- NCT07346599
- Acronym / sponsor ID
- 448
- Conditions
- Nerve Block, Postoperative Pain, Randomised Clinical Trial
- Keywords
- POSTOPERATİVE PAİN, ERECTOR SPİNA PLANE BLOCK, LUMBAR SPİNAL SURGERY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Kutahya City HospitalUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 16 Jan 2026 (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 purpose of this clinical trial is to evaluate whether bilateral lumbar erector spinae plane (ESP) block can reduce postoperative pain in adult patients undergoing lumbar spine surgery. The study also assesses the safety of this method and its effects on the recovery process. The main questions it aims to answer are:
Do patients who receive the ESP block experience less postoperative pain? Do these patients require fewer opioid (morphine-derived) analgesics? Does the first analgesic requirement occur later? Do patients mobilize earlier (stand/walk sooner)? Does the ESP block affect hemodynamic stability during and after surgery? Researchers will compare the ESP block group with the standard analgesia group to determine whether these effects occur.
Participants:
Patients in this study will be asked to:
Be randomly assigned to one of two groups before lumbar spine surgery Receive either a bilateral ESP block or standard analgesic therapy
Undergo postoperative follow-up including:
measurement of pain scores, recording of analgesic consumption, assessment of time to first analgesic requirement, monitoring of mobilization time, valuation of possible side effects
Detailed description
This randomized controlled study was designed to evaluate the effect of bilateral lumbar erector spinae plane (ESP) block on postoperative analgesia in patients undergoing lumbar spine surgery. A total of 102 patients scheduled for lumbar spine surgery were enrolled in the study and randomly assigned into two groups. One group received a bilateral ESP block at the L2-L4 levels using 20 mL of 0.25% bupivacaine on each side, while the control group received standard postoperative analgesia.
Postoperative pain assessment, opioid consumption, time to first analgesic request, mobilization time, intraoperative hemodynamic parameters, and the occurrence of adverse events were prospectively recorded according to a predefined follow-up protocol. The study was conducted using a prospective, randomized design to assess the efficacy and safety of bilateral lumbar ESP block for postoperative pain management in lumbar spine surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP BLOCK, | Active comparator | Procedure: ESP block group |
| CONTROL GROUP | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 and over, 80 and under
- American Society of Anesthesiologists Patient Classification Score (ASA) between I and Ⅲ
- Patients who can cooperate and give consent
- No chronic analgesic or opioid use
- No mental or psychiatric disorders
Key exclusion criteria (11 listed)
- -Patients who withdrew from participation at any time during the study
- Foreign nationals who could not be contacted
- Patients under 18 and over 80
- Patients with an ASA score of Ⅳ or higher
- Patients scheduled for emergency 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 |
|---|---|---|
| ESP block groupBILATERAL TWO-LEVEL ESP BLOCK WAS APPLIED TO PATIENTS UNDERGOING LUMBAR SPINAL SURGERY. | Procedure or surgery | ESP BLOCK, |
Primary outcome
VAS values of patients in the first 24 hours postoperatively
Time frame: The first 24 hours postoperatively
Zero indicates no pain, and 10 indicates the worst possible pain
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 16 Jan 2026.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Results publication: PubMed 34171466Goel VK, Chandramohan M, Murugan C, Shetty AP, Subramanian B, Kanna RM, Rajasekaran S. Clinical efficacy of ultrasound guided bilateral erector spinae block for single-level lumbar fusion surgery: a prospective, randomized, case-control study. Spine J. 2021 Nov;21(11):1873-1880. doi: 10.1016/j.spinee.2021.06.015. Epub 2021 Jun 23.
- Results publication: PubMed 31343504Tseng V, Xu JL. Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: Is There a Better Option? J Neurosurg Anesthesiol. 2021 Jan;33(1):92. doi: 10.1097/ANA.0000000000000631. No abstract available.
- Results publication: PubMed 36800574Liu H, Zhu J, Wen J, Fu Q. Ultrasound-guided erector spinae plane block for postoperative short-term outcomes in lumbar spine surgery: A meta-analysis and systematic review. Medicine (Baltimore). 2023 Feb 17;102(7):e32981. doi: 10.1097/MD.0000000000032981.
- Individual participant dataSharing planned: Undecided
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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.
merve kaynak principal investigator
Kütahya City Hospital
Ali Kaynak study chair
Kütahya City Hospital
bilal a bezen study chair
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP block group in people with Nerve Block and Postoperative Pain, run by Kutahya City 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 7 inclusion and 11 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 16 Jan 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?
VAS values of patients in the first 24 hours postoperatively (time frame: The first 24 hours postoperatively). 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 NCT07346599, which also lists 4 linked publications.
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 16 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.