Opioid ConsumptionNCT06815146
The Effects of ESP Block and Mid-Transverse Process to Pleura Block on Postoperative Opioid Consumption and Quality of Recovery
A study testing Numeretic rating scale (NRS), Quality of Results (QoR-40) and Opioid consuption in people with Opioid Consumption and Quality of Recovery(QoR-40), Preoperative and Postoperative, run by Aydin Adnan Menderes University.
Trial summary
Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) have recently been described for the treatment of pain after lumbar spinal surgery. Although these blocks have been shown to be effective in the treatment of pain after lumbar spinal surgery when compared with postoperative pain, they have… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid Consumption, Quality of Recovery(QoR-40), Preoperative and Postoperative
- What is being tested?
- Numeretic rating scale (NRS), Quality of Results (QoR-40) and Opioid consuption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 15 Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective Lumbar Spinal 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Effects of Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) on Postoperative Opioid Consumption and Quality of Recovery in Lumbar Spinal Surgery
Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) have recently been described for the treatment of pain after lumbar spinal surgery. Although these blocks have been shown to be effective in the treatment of pain after lumbar spinal surgery when compared with postoperative pain, they have not been compared in terms of the quality of recovery and opioid consumption after lumbar spinal surgery.
The aim of this clinical trial is to compare the effects of Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) on quality of recovery and opioid consumption in patients scheduled for lumbar spinal surgery. The effects of the 2 blocks on postoperative pain will also be compared and recorded.
- Being tested
- Numeretic rating scale (NRS), Quality of Results (QoR-40), Opioid consuption
- Keywords
- opioid consumption, quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numeretic rating scale (NRS)Diagnostic test
NRS is a pain intensity determination system based on the person being asked to describe their pain on a scale of 0 (none), 10 (unbearable pain) and a point between.
Quality of Results (QoR-40)Diagnostic test
Several rating scales have been developed to measure quality of recovery after surgery and anaesthesia, but the most extensively used is the QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain.
Opioid consuptionOther
Opioid consuption will be recorded from PCA
| Study group | Role | What they receive |
|---|---|---|
| esp block | Active comparator | Not described Receives: Diagnostic Test: Numeretic rating scale (NRS); Diagnostic Test: Quality of Results (QoR-40); Other: Opioid consuption |
| mtp block | Experimental | Not described Receives: Diagnostic Test: Numeretic rating scale (NRS); Diagnostic Test: Quality of Results (QoR-40); Other: Opioid consuption |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
The patient will be administered tramadol PCA every eight hours and recorded.
Measured: PCA results will be recorded at the 1st, 6th, 12th, 24th hours postoperatively.
Secondary outcomes (1)
quality of recovery
The quality of recovery (QoR-40) of patients who underwent both ESP block and MTP block at the 24th hour postoperatively will be evaluated with a scoring system.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid ConsumptionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 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
- NCT06815146
- Sponsor's protocol ID
- 2025
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eskin MB, Ceylan A, Ozhan MO, Atik B. Ultrasound-guided erector spinae block versus mid-transverse process to pleura block for postoperative analgesia in lumbar spinal surgery. Anaesthesist. 2020 Oct;69(10):742-750. doi: 10.1007/s00101-020-00848-w. Epub 2020 Sep 21.
PubMed 32955601
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) on Postoperative Opioid Consumption and Quality of Recovery in Lumbar Spinal Surgery
- ClinicalTrials.gov ID
- NCT06815146
- Acronym / sponsor ID
- 2025
- Keywords
- opioid consumption, quality of recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 7 Feb 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.
Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) have recently been described for the treatment of pain after lumbar spinal surgery. Although these blocks have been shown to be effective in the treatment of pain after lumbar spinal surgery when compared with postoperative pain, they have not been compared in terms of the quality of recovery and opioid consumption after lumbar spinal surgery.
The aim of this clinical trial is to compare the effects of Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) on quality of recovery and opioid consumption in patients scheduled for lumbar spinal surgery. The effects of the 2 blocks on postoperative pain will also be compared and recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esp block | Active comparator | Diagnostic Test: Numeretic rating scale (NRS), Diagnostic Test: Quality of Results (QoR-40), Other: Opioid consuption |
| mtp block | Experimental | Diagnostic Test: Numeretic rating scale (NRS), Diagnostic Test: Quality of Results (QoR-40), Other: Opioid consuption |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective Lumbar Spinal 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 |
|---|---|---|
| Numeretic rating scale (NRS)NRS is a pain intensity determination system based on the person being asked to describe their pain on a scale of 0 (none), 10 (unbearable pain) and a point between. | Diagnostic test | esp block, mtp block |
| Quality of Results (QoR-40)Several rating scales have been developed to measure quality of recovery after surgery and anaesthesia, but the most extensively used is the QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. | Diagnostic test | esp block, mtp block |
| Opioid consuptionOpioid consuption will be recorded from PCA | Other | esp block, mtp block |
Primary outcome
postoperative opioid consumption
Time frame: PCA results will be recorded at the 1st, 6th, 12th, 24th hours postoperatively.
The patient will be administered tramadol PCA every eight hours and recorded.
1 secondary outcome
quality of recovery
Time frame: 24 hours
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 7 Feb 2025.
- Results publication: PubMed 32955601Eskin MB, Ceylan A, Ozhan MO, Atik B. Ultrasound-guided erector spinae block versus mid-transverse process to pleura block for postoperative analgesia in lumbar spinal surgery. Anaesthesist. 2020 Oct;69(10):742-750. doi: 10.1007/s00101-020-00848-w. Epub 2020 Sep 21.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Numeretic rating scale (NRS), Quality of Results (QoR-40) and Opioid consuption in people with Opioid Consumption and Quality of Recovery(QoR-40), Preoperative and Postoperative, run by Aydin Adnan Menderes University.
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 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: opening soon, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Sinem Sarı, Prof Dr (90 256 220 2108, sarisinem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative opioid consumption (time frame: PCA results will be recorded at the 1st, 6th, 12th, 24th 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 NCT06815146, which also lists 1 linked publication.
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 7 Feb 2025.