Postoperative Pain ManagementNCT07852104
COMPARISON OF THE EFFECTS OF ERECTOR SPINAE PLANE (ESP) BLOCK AND QUADRO İLİAC PLANE (QIP) BLOCK ON POSTOPERATIVE OPIOID CONSUMPTION AND PAIN IN LUMBAR SPINAL SURGERY
A study testing NRS Score, total tramadol consumption and Post Operative Pain Relievers in people with Postoperative Pain Management, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
COMPARISON OF THE EFFECTS OF ERECTOR SPINAE PLANE (ESP) BLOCK AND QUADRO İLİAC PLANE (QIP) BLOCK ON POSTOPERATIVE OPIOID CONSUMPTION AND PAIN IN LUMBAR SPINAL SURGERY Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- NRS Score, total tramadol consumption and Post Operative Pain Relievers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 30 Dec 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective lumbar spinal surgery
- ASA I-III
- Aged 18-75 years Exclusion Criteria: - 1. Refusal at the time of enrollment 2. Request to withdraw from the study 3. Inability to provide informed consent 4. Emergency surgery 5. Bleeding diathesis 6. Presence of contraindications to the local anesthetic (LA) agents used in this study 7. Chronic opioid use 8. Psychiatric disorders 9. Presence of infection at the injection site
Who cannot join
None listed.
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
Aydin Adnan Menderes Üniversitesi Tip Fakültesi Hastanesi
Aydin, 09100
About this study
Official title: COMPARISON OF THE EFFECTS OF ERECTOR SPINAE PLANE (ESP) BLOCK AND QUADRO ILIAC PLANE (QIP) BLOCK ON POSTOPERATIVE OPIOID CONSUMPTION AND PAIN IN LUMBAR SPINAL SURGERY
COMPARISON OF THE EFFECTS OF ERECTOR SPINAE PLANE (ESP) BLOCK AND QUADRO İLİAC PLANE (QIP) BLOCK ON POSTOPERATIVE OPIOID CONSUMPTION AND PAIN IN LUMBAR SPINAL SURGERY
Read the detailed description
The study is designed as a double-blind, prospective, randomized controlled trial. Regarding blinding, the healthcare personnel responsible for monitoring postoperative pain will be unaware of whether the patients received an ESP block or a QIP block. Patient randomization was planned using a computer-based system. Following the operation, once patients are transferred to the postoperative recovery room, their pain levels will be assessed and recorded using the Numeric Rating Scale (NRS) at the following time points: 30 minutes, and 1, 6, 12, and 24 hours. In the ward, patients will receive tramadol via PCA and paracetamol every eight hours. Hourly NRS monitoring is planned during the patient's follow-up in the ward. If the NRS score reaches 4 or higher during this period, 75 mg of diclofenac sodium will be administered intramuscularly, and the number of self-administered bolus doses via PCA (Patient-Controlled Analgesia) within the first 24 hours will be recorded. Opioid consumption and pain levels (via NRS scores) will be evaluated at the 24th postoperative hour for patients in both the ESP and QIP block groups. Additionally, the patients' hemodynamic parameters will be recorded at these time intervals.
- Conditions
- Postoperative Pain Management
- Being tested
- NRS Score, total tramadol consumption, Post Operative Pain Relievers
- Keywords
- Erector spinae region block, lumbar spine surgeries, opioid consumption, quadro iliac plane block, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRS ScoreDiagnostic test
An 11-point Numerical Rating Scale (NRS), where 0 indicated no pain and 10 represented the worst pain imaginable, was used to assess patients' pain levels.
total tramadol consumptionDiagnostic test
The total number of patient-controlled analgesia (PCA) bolus doses delivered within the first 24 hours will record
Post Operative Pain RelieversDrug
Also called DİCLOFENAK SODYUM, PCA İLE TRAMADOL, PARASETAMOL
All patients in the ward will be administered intravenous paracetamol every 8 hours, and intramuscular diclofenac sodium (75 mg) if the NRS score is 4 or higher.
| Study group | Role | What they receive |
|---|---|---|
| ESP BLOCK | Active comparator | Not described Receives: Diagnostic Test: NRS Score; Diagnostic Test: total tramadol consumption; Drug: Post Operative Pain Relievers |
| QIP BLOCK | Experimental | Not described Receives: Diagnostic Test: NRS Score; Diagnostic Test: total tramadol consumption; Drug: Post Operative Pain Relievers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effects of the Quadro İliac Plane Block and the Erector Spinae Plane (ESP) Block on postoperative opioid consumption in lumbar spinal surgeries
All patients will be administered tramadol via PCA, and the amount of tramadol consumed will be assessed at the end of the 24-hour postoperative period.
Measured: 24 hour
Secondary outcomes (1)
To compare the effects of the Quadro iliac (Qıp) block and the Erector Spinae Plane (ESP) block on postoperative pain in lumbar spinal surgeries
The NRS score will be assessed on a scale of 0 to 10, with 0 representing the lowest and 10 the highest value; patients will be asked to provide a rating at the 12th hour.
Measured: 12th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a double blind,prospective randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SINEM SARI, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852104
- Sponsor's protocol ID
- 2026/302
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE EFFECTS OF ERECTOR SPINAE PLANE (ESP) BLOCK AND QUADRO ILIAC PLANE (QIP) BLOCK ON POSTOPERATIVE OPIOID CONSUMPTION AND PAIN IN LUMBAR SPINAL SURGERY
- ClinicalTrials.gov ID
- NCT07852104
- Acronym / sponsor ID
- 2026/302
- Conditions
- Postoperative Pain Management
- Keywords
- Erector spinae region block, lumbar spine surgeries, opioid consumption, quadro iliac plane block, postoperative pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 1 Oct 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.
COMPARISON OF THE EFFECTS OF ERECTOR SPINAE PLANE (ESP) BLOCK AND QUADRO İLİAC PLANE (QIP) BLOCK ON POSTOPERATIVE OPIOID CONSUMPTION AND PAIN IN LUMBAR SPINAL SURGERY
Detailed description
The study is designed as a double-blind, prospective, randomized controlled trial. Regarding blinding, the healthcare personnel responsible for monitoring postoperative pain will be unaware of whether the patients received an ESP block or a QIP block. Patient randomization was planned using a computer-based system. Following the operation, once patients are transferred to the postoperative recovery room, their pain levels will be assessed and recorded using the Numeric Rating Scale (NRS) at the following time points: 30 minutes, and 1, 6, 12, and 24 hours. In the ward, patients will receive tramadol via PCA and paracetamol every eight hours. Hourly NRS monitoring is planned during the patient's follow-up in the ward. If the NRS score reaches 4 or higher during this period, 75 mg of diclofenac sodium will be administered intramuscularly, and the number of self-administered bolus doses via PCA (Patient-Controlled Analgesia) within the first 24 hours will be recorded. Opioid consumption and pain levels (via NRS scores) will be evaluated at the 24th postoperative hour for patients in both the ESP and QIP block groups. Additionally, the patients' hemodynamic parameters will be recorded at these time intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study was designed as a double blind,prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| ESP BLOCK | Active comparator | Diagnostic Test: NRS Score, Diagnostic Test: total tramadol consumption, Drug: Post Operative Pain Relievers |
| QIP BLOCK | Experimental | Diagnostic Test: NRS Score, Diagnostic Test: total tramadol consumption, Drug: Post Operative Pain Relievers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing elective lumbar spinal surgery
- ASA I-III
- Aged 18-75 years Exclusion Criteria: - 1. Refusal at the time of enrollment 2. Request to withdraw from the study 3. Inability to provide informed consent 4. Emergency surgery 5. Bleeding diathesis 6. Presence of contraindications to the local anesthetic (LA) agents used in this study 7. Chronic opioid use 8. Psychiatric disorders 9. Presence of infection at the injection site
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NRS ScoreAn 11-point Numerical Rating Scale (NRS), where 0 indicated no pain and 10 represented the worst pain imaginable, was used to assess patients' pain levels. | Diagnostic test | ESP BLOCK, QIP BLOCK |
| total tramadol consumptionThe total number of patient-controlled analgesia (PCA) bolus doses delivered within the first 24 hours will record | Diagnostic test | ESP BLOCK, QIP BLOCK |
| Post Operative Pain RelieversAlso: DİCLOFENAK SODYUM, PCA İLE TRAMADOL, PARASETAMOLAll patients in the ward will be administered intravenous paracetamol every 8 hours, and intramuscular diclofenac sodium (75 mg) if the NRS score is 4 or higher. | Drug | ESP BLOCK, QIP BLOCK |
Primary outcome
To compare the effects of the Quadro İliac Plane Block and the Erector Spinae Plane (ESP) Block on postoperative opioid consumption in lumbar spinal surgeries
Time frame: 24 hour
All patients will be administered tramadol via PCA, and the amount of tramadol consumed will be assessed at the end of the 24-hour postoperative period.
1 secondary outcome
To compare the effects of the Quadro iliac (Qıp) block and the Erector Spinae Plane (ESP) block on postoperative pain in lumbar spinal surgeries
Time frame: 12th hour
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 1 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NRS Score, total tramadol consumption and Post Operative Pain Relievers in people with Postoperative Pain Management, run by Aydin Adnan Menderes University 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 3 inclusion and 0 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: opening soon, as of the sponsor's last update on 1 Oct 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 SİNEM SARI PROF DR (902564441256, sarisinem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effects of the Quadro İliac Plane Block and the Erector Spinae Plane (ESP) Block on postoperative opioid consumption in lumbar spinal surgeries (time frame: 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 1 Oct 2026.