Postoperative PainSPINE-ANINCT07455565
Postoperative Pain Monitoring With ANI in Lumbar Spine Surgery
A study testing Erector Spinae Plane Block and Intravenous Multimodal Analgesia in people with Postoperative Pain and Lumbar Spine Surgery, run by Akdeniz University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare two different pain management methods in patients undergoing elective lumbar spine surgery. Patients are randomly assigned to receive either an ultrasound-guided erector spinae plane block (ESPB) or intravenous multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Lumbar Spine Surgery
- What is being tested?
- Erector Spinae Plane Block and Intravenous Multimodal Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age between 18 and 65 years
- ASA physical status I-II
- Scheduled for elective lumbar spine surgery
- Ability to provide informed consent
Who cannot join
- Known allergy to study medications
- Coagulation disorders
- Infection at the block site
- Severe cardiovascular disease
- Pregnancy
- Inability to understand the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University Faculty of Medicine Hospital
Antalya, Antalya, 0707
Ayşe Tekin, MD, +905376180290, aysesstekin@gmail.com
About this study
Official title: Comparison Of Postoperative Analgesic Efficacy Using Analgesia Nociception Index Monitoring In Patients Undergoing Elective Lumbar Spine Surgery: A Randomized Parallel-Group Study
This study aims to compare two different pain management methods in patients undergoing elective lumbar spine surgery. Patients are randomly assigned to receive either an ultrasound-guided erector spinae plane block (ESPB) or intravenous multimodal analgesia.
Postoperative pain will be assessed using both clinical pain scores and the Analgesia Nociception Index (ANI), a non-invasive monitoring system that evaluates pain-related responses based on heart rate variability. The goal of this study is to determine which method provides better postoperative pain control.
Read the detailed description
Effective postoperative pain management is essential in lumbar spine surgery to improve patient comfort and recovery. Traditional pain assessment methods rely on subjective scales, such as the Visual Analog Scale (VAS). The Analgesia Nociception Index (ANI) is a non-invasive monitoring tool based on heart rate variability analysis that provides an objective assessment of the balance between nociception and analgesia.
This randomized parallel-group clinical study compares two analgesic strategies in adult patients undergoing elective lumbar spine surgery. Participants are randomly assigned using a simple lottery method to receive either ultrasound-guided bilateral erector spinae plane block (ESPB) or intravenous multimodal analgesia.
ANI values are recorded at postoperative 0, 15, 30, 45, 60, 90, 120, and 180. minutes, and at 6, 12, and 24. hours. These measurements are evaluated together with clinical pain scores, total opioid consumption within 24 hours, hemodynamic parameters, and adverse events.
The primary objective is to compare ANI values between the two groups during the early postoperative period. Secondary objectives include comparison of VAS scores, opioid requirements, and incidence of analgesia-related adverse effects.
- Conditions
- Postoperative Pain, Lumbar Spine Surgery
- Being tested
- Erector Spinae Plane Block, Intravenous Multimodal Analgesia
- Keywords
- Analgesia Nociception Index, Erector Spinae Plane Block, Postoperative Pain, Lumbar Spine Surgery, Multimodal Analgesia, Randomized Controlled Trial
- Medical subject headings
- Pain, Postoperative
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 bilateral erector spinae plane block performed at the thoracolumbar level using a total of 200 mg bupivacaine for postoperative analgesia.
Intravenous Multimodal AnalgesiaDrug
Also called IV Multimodal Analgesia
Intravenous administration of paracetamol 1 g, morphine 0.1 mg/kg, dexamethasone 8 mg, and ketamine 0.5 mg/kg bolus followed by 0.3 mg/kg/h infusion for postoperative pain management.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Ultrasound-guided bilateral erector spinae plane block performed at the thoracolumbar level using a total of 200 mg bupivacaine for postoperative analgesia. Receives: Procedure: Erector Spinae Plane Block |
| Intravenous Multimodal Analgesia | Active comparator | Intravenous multimodal analgesia including paracetamol 1 g, morphine 0.1 mg/kg, dexamethasone 8 mg, and ketamine 0.5 mg/kg bolus followed by 0.3 mg/kg/h infusion. Receives: Drug: Intravenous Multimodal Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia Nociception Index (ANI)
Analgesia Nociception Index (ANI) measured using the ANI monitor. The ANI ranges from 0 to 100. Higher values indicate greater parasympathetic tone and lower nociceptive stimulation, whereas lower values indicate higher nociceptive stimulation.
Measured: From 0 minutes to 24 hours postoperatively
Secondary outcomes (2)
Visual Analog Scale (VAS) Pain Score
Pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Measured: From 0 minutes to 24 hours postoperatively
Postoperative Nausea
Incidence of postoperative nausea within 24 hours after surgery.
Measured: Within 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 posted6 Mar 2026
- Study start16 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- Model description
- Participants are randomly assigned using a simple lottery method to one of two parallel groups: ultrasound-guided bilateral erector spinae plane block (ESPB) or intravenous multimodal analgesia. Outcomes are compared between groups during the early postoperative period.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Tekin, Akdeniz University Hospital
- Investigators
- Neval Boztuğ, MD, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455565
- Sponsor's protocol ID
- AU-ANES-ANI-2025-360
- Other IDs
- BAP Project No: 6976
- Acronym
- SPINE-ANI
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Postoperative Analgesic Efficacy Using Analgesia Nociception Index Monitoring In Patients Undergoing Elective Lumbar Spine Surgery: A Randomized Parallel-Group Study
- ClinicalTrials.gov ID
- NCT07455565
- Acronym / sponsor ID
- SPINE-ANI / AU-ANES-ANI-2025-360
- Conditions
- Postoperative Pain, Lumbar Spine Surgery
- Keywords
- Analgesia Nociception Index, Erector Spinae Plane Block, Postoperative Pain, Lumbar Spine Surgery, Multimodal Analgesia, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Akdeniz University HospitalUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Mar 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.
This study aims to compare two different pain management methods in patients undergoing elective lumbar spine surgery. Patients are randomly assigned to receive either an ultrasound-guided erector spinae plane block (ESPB) or intravenous multimodal analgesia.
Postoperative pain will be assessed using both clinical pain scores and the Analgesia Nociception Index (ANI), a non-invasive monitoring system that evaluates pain-related responses based on heart rate variability. The goal of this study is to determine which method provides better postoperative pain control.
Detailed description
Effective postoperative pain management is essential in lumbar spine surgery to improve patient comfort and recovery. Traditional pain assessment methods rely on subjective scales, such as the Visual Analog Scale (VAS). The Analgesia Nociception Index (ANI) is a non-invasive monitoring tool based on heart rate variability analysis that provides an objective assessment of the balance between nociception and analgesia.
This randomized parallel-group clinical study compares two analgesic strategies in adult patients undergoing elective lumbar spine surgery. Participants are randomly assigned using a simple lottery method to receive either ultrasound-guided bilateral erector spinae plane block (ESPB) or intravenous multimodal analgesia.
ANI values are recorded at postoperative 0, 15, 30, 45, 60, 90, 120, and 180. minutes, and at 6, 12, and 24. hours. These measurements are evaluated together with clinical pain scores, total opioid consumption within 24 hours, hemodynamic parameters, and adverse events.
The primary objective is to compare ANI values between the two groups during the early postoperative period. Secondary objectives include comparison of VAS scores, opioid requirements, and incidence of analgesia-related adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned using a simple lottery method to one of two parallel groups: ultrasound-guided bilateral erector spinae plane block (ESPB) or intravenous multimodal analgesia. Outcomes are compared between groups during the early postoperative period.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Procedure: Erector Spinae Plane BlockUltrasound-guided bilateral erector spinae plane block performed at the thoracolumbar level using a total of 200 mg bupivacaine for postoperative analgesia. |
| Intravenous Multimodal Analgesia | Active comparator | Drug: Intravenous Multimodal AnalgesiaIntravenous multimodal analgesia including paracetamol 1 g, morphine 0.1 mg/kg, dexamethasone 8 mg, and ketamine 0.5 mg/kg bolus followed by 0.3 mg/kg/h infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- ASA physical status I-II
- Scheduled for elective lumbar spine surgery
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Known allergy to study medications
- Coagulation disorders
- Infection at the block site
- Severe cardiovascular disease
- 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 |
|---|---|---|
| Erector Spinae Plane BlockUltrasound-guided bilateral erector spinae plane block performed at the thoracolumbar level using a total of 200 mg bupivacaine for postoperative analgesia. | Procedure or surgery | Erector Spinae Plane Block |
| Intravenous Multimodal AnalgesiaAlso: IV Multimodal AnalgesiaIntravenous administration of paracetamol 1 g, morphine 0.1 mg/kg, dexamethasone 8 mg, and ketamine 0.5 mg/kg bolus followed by 0.3 mg/kg/h infusion for postoperative pain management. | Drug | Intravenous Multimodal Analgesia |
Primary outcome
Analgesia Nociception Index (ANI)
Time frame: From 0 minutes to 24 hours postoperatively
Analgesia Nociception Index (ANI) measured using the ANI monitor. The ANI ranges from 0 to 100. Higher values indicate greater parasympathetic tone and lower nociceptive stimulation, whereas lower values indicate higher nociceptive stimulation.
2 secondary outcomes
Visual Analog Scale (VAS) Pain Score
Time frame: From 0 minutes to 24 hours postoperatively
Postoperative Nausea
Time frame: Within 24 hours postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.
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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.
Neval Boztuğ, MD principal investigator
Akdeniz 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 Erector Spinae Plane Block and Intravenous Multimodal Analgesia in people with Postoperative Pain and Lumbar Spine Surgery, run by Akdeniz University 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 6 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: looking for participants now, as of the sponsor's last update on 6 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Tekin, MD (+905376180290, aysesstekin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia Nociception Index (ANI) (time frame: From 0 minutes to 24 hours postoperatively). 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 Mar 2026.