Postoperative Quality of Recovery and Pain ManagementNCT07065006
Comparison of the Effects of Local Anesthetic Infiltration and Erector Spinae Plan (ESP) Block on Postoperative Recovery Quality and Pain in Lumbar Spinal Surgery
A study testing Qor-40 test (The recovery quality test) and Calculation of postoperative opioid consumption in people with Postoperative Quality of Recovery and Pain Management, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the Effects of Local Anesthetic Infiltration and Erector Spinae Plan (ESP) Block on Postoperative Recovery Quality 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 Quality of Recovery and Pain Management
- What is being tested?
- Qor-40 test (The recovery quality test) and Calculation of postoperative opioid consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2025to 12 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective lumbar surgery performed ASA I-III 18-75 years old
Who cannot join
- Refusal at enrollment
- Request for withdrawal from the study
- Inability to give informed consent
- Emergency surgery
- Bleeding diathesis
- Presence of contraindications to the LA agents used in this study
Show all 9Show fewer
- Use of chronic opioids
- Psychiatric disorders
- Presence of infection at the injection site
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes Üniversitesi Tıp Fakulresi Hastanesi
Aydin, 09100
About this study
Comparison of the Effects of Local Anesthetic Infiltration and Erector Spinae Plan (ESP) Block on Postoperative Recovery Quality and Pain in Lumbar Spinal Surgery
Read the detailed description
The study was designed as a double-blind, prospective randomized controlled study. Blindness; healthcare professionals who will monitor the patient's pain in the postoperative period will not know whether ESP or wound local anesthetic infiltration block was applied. Randomization of the patients was planned to be done using computer support. It was planned to include 44 participants in the ESP block and wound local anesthetic infiltration groups. The current pain status of the patients in the ESP block and wound local anesthetic infiltration groups in the postoperative period will be evaluated with NRS (Numerical rating scale) at certain time intervals (30th min, 1st, 6th, 12th, 24th hour) during rest and movement. When the patients' NRS scores are 4 and above, intravenous analgesic will be administered additionally and the number of bolus doses of the patients with PCA in the first 24 hours will be recorded. The recovery quality of the patients who underwent both ESP block and RLB block at the postoperative 24th hour will be evaluated with the scoring system (QoR-40). Additionally, the patients' hemodynamic values will be recorded during these intervals.
- Being tested
- Qor-40 test (The recovery quality test), Calculation of postoperative opioid consumption
- Keywords
- wound local anesthetic infiltration, Erector Spinae Area (ESP) Block, quality of postoperative recovery, lumbar spinal surgeries
- Medical subject headings
- Agnosia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qor-40 test (The recovery quality test)Diagnostic test
Scale of postoperative recovery quality at first 24th hour. Minimum score is 40=bad ,maximum score is 200=good
Calculation of postoperative opioid consumptionOther
Postoperative opioid consumptions on the pca (patient controlled analgesia) device of the patients will be recorded in Postoperative 30.min,1.,6.,12.,24. Opioid consumptions on the pca device of the patients will be recorded in 30.min,1.,6.,12.,24. hours.
| Study group | Role | What they receive |
|---|---|---|
| esp | Other | After anesthesia and surgical intervention, bilateral ESP will be extended with ultrasound guidance from the midline 3 cm lateral at the T10 level. After the area is cleaned with povidone iodine before the block, the T10 transverse parts will be determined using a linear ultrasound probe. Local anesthetic will be applied to the erector spinae muscle with the needle used for peripheral block procedures and the transverse processor. Without administering local anesthesia, the location of the needle will be verified with the hydrodissection method with serum. After the location of the needle is verified, 20 ml of LA and a different mixture of serum will be changed and the same procedure will be repeated in the contralateral. 20 ml of the total 40 ml of LA will be bupivacaine 0.5%, which can be seen in 20 ml of serum. Receives: Diagnostic Test: Qor-40 test (The recovery quality test); Other: Calculation of postoperative opioid consumption |
| wound LAI | Other | For patients assigned to wound infiltration, 40 mL (20 ml of the total 40 ml of LA will be bupivacaine 0.5%, which can be seen in 20 ml of serum) will be infiltrated on both sides of the wound edges after closure. Receives: Diagnostic Test: Qor-40 test (The recovery quality test); Other: Calculation of postoperative opioid consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qor-40 test (The recovery quality test)
scale of postoperative recovery quality at first 24th hour. Minimum score is 40=bad ,maximum score is 200=good
Measured: 24th hour
Secondary outcomes (1)
Postoperative opioid consumption
Postoperative opioid consumptions on the pca (patient controlled analgesia) device of the patients will be recorded in Postoperative 30.min,1.,6.,12.,24. Opioid consumptions on the pca device of the patients will be recorded in 30.min,1.,6.,12.,24. hours.
Measured: 30 minutes,1st hour,6th hour,12th hour and 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start10 Jul 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Quality of Recovery and 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 (actual)
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
- NCT07065006
- Sponsor's protocol ID
- 2025-150
- Other IDs
- 2025-150
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2025
- Last updated
- 6 May 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Local Anesthetic Infiltration and Erector Spinae Plan (ESP) Block on Postoperative Recovery Quality and Pain in Lumbar Spinal Surgery
- ClinicalTrials.gov ID
- NCT07065006
- Acronym / sponsor ID
- 2025-150
- Keywords
- wound local anesthetic infiltration, Erector Spinae Area (ESP) Block, quality of postoperative recovery, lumbar spinal surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 15 Jul 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.
Comparison of the Effects of Local Anesthetic Infiltration and Erector Spinae Plan (ESP) Block on Postoperative Recovery Quality and Pain in Lumbar Spinal Surgery
Detailed description
The study was designed as a double-blind, prospective randomized controlled study. Blindness; healthcare professionals who will monitor the patient's pain in the postoperative period will not know whether ESP or wound local anesthetic infiltration block was applied. Randomization of the patients was planned to be done using computer support. It was planned to include 44 participants in the ESP block and wound local anesthetic infiltration groups. The current pain status of the patients in the ESP block and wound local anesthetic infiltration groups in the postoperative period will be evaluated with NRS (Numerical rating scale) at certain time intervals (30th min, 1st, 6th, 12th, 24th hour) during rest and movement. When the patients' NRS scores are 4 and above, intravenous analgesic will be administered additionally and the number of bolus doses of the patients with PCA in the first 24 hours will be recorded. The recovery quality of the patients who underwent both ESP block and RLB block at the postoperative 24th hour will be evaluated with the scoring system (QoR-40). Additionally, the patients' hemodynamic values will be recorded during these 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 | Other | Diagnostic Test: Qor-40 test (The recovery quality test), Other: Calculation of postoperative opioid consumptionAfter anesthesia and surgical intervention, bilateral ESP will be extended with ultrasound guidance from the midline 3 cm lateral at the T10 level. After the area is cleaned with povidone iodine before the block, the T10 transverse parts will be determined using a linear ultrasound probe. Local anesthetic will be applied to the erector spinae muscle with the needle used for peripheral block procedures and the transverse processor. Without administering local anesthesia, the location of the needle will be verified with the hydrodissection method with serum. After the location of the needle is verified, 20 ml of LA and a different mixture of serum will be changed and the same procedure will be repeated in the contralateral. 20 ml of the total 40 ml of LA will be bupivacaine 0.5%, which can be seen in 20 ml of serum. |
| wound LAI | Other | Diagnostic Test: Qor-40 test (The recovery quality test), Other: Calculation of postoperative opioid consumptionFor patients assigned to wound infiltration, 40 mL (20 ml of the total 40 ml of LA will be bupivacaine 0.5%, which can be seen in 20 ml of serum) will be infiltrated on both sides of the wound edges after closure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective lumbar surgery performed ASA I-III 18-75 years old
Key exclusion criteria (9 listed)
- Refusal at enrollment
- Request for withdrawal from the study
- Inability to give informed consent
- Emergency surgery
- Bleeding diathesis
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 |
|---|---|---|
| Qor-40 test (The recovery quality test)Scale of postoperative recovery quality at first 24th hour. Minimum score is 40=bad ,maximum score is 200=good | Diagnostic test | esp, wound LAI |
| Calculation of postoperative opioid consumptionPostoperative opioid consumptions on the pca (patient controlled analgesia) device of the patients will be recorded in Postoperative 30.min,1.,6.,12.,24. Opioid consumptions on the pca device of the patients will be recorded in 30.min,1.,6.,12.,24. hours. | Other | esp, wound LAI |
Primary outcome
Qor-40 test (The recovery quality test)
Time frame: 24th hour
scale of postoperative recovery quality at first 24th hour. Minimum score is 40=bad ,maximum score is 200=good
1 secondary outcome
Postoperative opioid consumption
Time frame: 30 minutes,1st hour,6th hour,12th hour and 24th hour
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 6 May 2026.
- Individual participant dataSharing planned: Undecided
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?
A study testing Qor-40 test (The recovery quality test) and Calculation of postoperative opioid consumption in people with Postoperative Quality of Recovery and 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 1 inclusion and 9 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 6 May 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?
Qor-40 test (The recovery quality test) (time frame: 24th 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 6 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.