Lumbar Disc HerniationNCT06391541
mTLIP vs. ITP Blocks in Lumbar Disc Surgery
A study testing modified thoracolumbar interfacial plan block (mTLIP) and Intertransverse process block (ITP) in people with Lumbar Disc Herniation and Pain, Postoperative, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
to compare ultrasonography (USG)-guided intertransverse process block and modified thoracolumbar interfascial plan (mTLIP) block in the treatment of postoperative pain in patients undergoing lumbar disc herniation surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Pain, Postoperative, Regional Aneshesia
- What is being tested?
- modified thoracolumbar interfacial plan block (mTLIP) and Intertransverse process block (ITP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years old
- ASA I-II-III risk group
- Patients whose consent was obtained with an informed consent form
- Patients who will undergo lumbar disc herniation surgery
Who cannot join
- Patients who refused to participate in the study
- Allergic to local anesthetics
- Patients with coagulopathy
- Infection at the site of intervention
- Patients under 18 years of age
- Patients with ASA score IV and above
Show all 14Show fewer
- Chronic pain disorders
- Those with neurological or neuromuscular disease
- Patients with psychiatric problems
- Patients with a history of opioid use
- Chronic use of NSAIDs
- Those contraindicated for regional anesthesia
- Patients with a history of opioid use
- Chronic analgesic use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University medicine faculty
Zonguldak, Kozlu, 67600
About this study
Official title: Comparison of the Effects of Modified Thoracolumbar Interfacial Plan Block (mTLIP) and Intertransverse Process Block in Lumbar Disc Surgery
to compare ultrasonography (USG)-guided intertransverse process block and modified thoracolumbar interfascial plan (mTLIP) block in the treatment of postoperative pain in patients undergoing lumbar disc herniation surgery under general anesthesia.
- Being tested
- modified thoracolumbar interfacial plan block (mTLIP), Intertransverse process block (ITP)
- Keywords
- postoperative pain, opioid consumption, Pain management, nerve blocks, QoR-15
- Medical subject headings
- Intervertebral Disc Displacement, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified thoracolumbar interfacial plan block (mTLIP)Procedure or surgery
Injecting local anesthetic at L3 vertebral level between the longisimus and iliocostalis muscles within the erector spinae muscles.
Intertransverse process block (ITP)Procedure or surgery
injection of local anesthetic on the superior costotransverse ligament between the transverse process and the pleura.
| Study group | Role | What they receive |
|---|---|---|
| Group Control | No intervention | Not described |
| Group mTLIP | Active comparator | Not described Receives: Procedure: modified thoracolumbar interfacial plan block (mTLIP) |
| Group ITP | Active comparator | Not described Receives: Procedure: Intertransverse process block (ITP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
total amount of opioids consumed in 24 hours postoperatively
Measured: up to 24 hours after surgery
Secondary outcomes (3)
pain scores
Patients will be evaluated at regular intervals after surgery and their pain will be measured using a numerical rating scale.
Measured: up to 24 hours after surgery
incidence of nausea and vomiting
nausea and vomiting of postoperative patients will be evaluated
Measured: up to 24 hours after surgery
Quality of Recovery-15 scale
The quality of recovery of patients will be assessed with the quality of recovery 15 questionnaire.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Apr 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (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 Lumbar Disc HerniationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağdaş Baytar, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391541
- Sponsor's protocol ID
- 2024/06-18
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asker D, Baytar C, Baytar MS, Kurada G, Bollucuoglu K, Okyay RD, Incegul BGK, Piskin O, Ayoglu H. Intertransverse process and modified thoracolumbar interfascial plane blocks compared with conventional analgesia in lumbar disc herniation surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Jul 14. doi: 10.1186/s12871-026-04094-2. Online ahead of print.
PubMed 42449236
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Modified Thoracolumbar Interfacial Plan Block (mTLIP) and Intertransverse Process Block in Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT06391541
- Acronym / sponsor ID
- 2024/06-18
- Keywords
- postoperative pain, opioid consumption, Pain management, nerve blocks, QoR-15
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
to compare ultrasonography (USG)-guided intertransverse process block and modified thoracolumbar interfascial plan (mTLIP) block in the treatment of postoperative pain in patients undergoing lumbar disc herniation surgery under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Control | No intervention | – |
| Group mTLIP | Active comparator | Procedure: modified thoracolumbar interfacial plan block (mTLIP) |
| Group ITP | Active comparator | Procedure: Intertransverse process block (ITP) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old
- ASA I-II-III risk group
- Patients whose consent was obtained with an informed consent form
- Patients who will undergo lumbar disc herniation surgery
Key exclusion criteria (14 listed)
- Patients who refused to participate in the study
- Allergic to local anesthetics
- Patients with coagulopathy
- Infection at the site of intervention
- Patients under 18 years of age
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 |
|---|---|---|
| modified thoracolumbar interfacial plan block (mTLIP)Injecting local anesthetic at L3 vertebral level between the longisimus and iliocostalis muscles within the erector spinae muscles. | Procedure or surgery | Group mTLIP |
| Intertransverse process block (ITP)injection of local anesthetic on the superior costotransverse ligament between the transverse process and the pleura. | Procedure or surgery | Group ITP |
Primary outcome
postoperative opioid consumption
Time frame: up to 24 hours after surgery
total amount of opioids consumed in 24 hours postoperatively
3 secondary outcomes
pain scores
Time frame: up to 24 hours after surgery
incidence of nausea and vomiting
Time frame: up to 24 hours after surgery
Quality of Recovery-15 scale
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 42449236Asker D, Baytar C, Baytar MS, Kurada G, Bollucuoglu K, Okyay RD, Incegul BGK, Piskin O, Ayoglu H. Intertransverse process and modified thoracolumbar interfascial plane blocks compared with conventional analgesia in lumbar disc herniation surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Jul 14. doi: 10.1186/s12871-026-04094-2. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
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 modified thoracolumbar interfacial plan block (mTLIP) and Intertransverse process block (ITP) in people with Lumbar Disc Herniation and Pain, Postoperative, run by Zonguldak Bulent Ecevit 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
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?
postoperative opioid consumption (time frame: up to 24 hours after surgery). 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 NCT06391541, 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 30 Apr 2024.