Low Back PainNCT07166900
Modified Thoracolumbar Interfascial Plane Block Versus Erector Spinae Plane Block For Enhancement Of Quality of Recovery After Lumbar Spine Surgery: A Prospective Randomized Controlled Study.
A study testing Modified Thoracolumbar Interfascial Plane Block in people with Low Back Pain, run by Fayoum University at 1 site in Egypt.
Trial summary
Aim of study The objective of the current study is to compare the efficacy of ultrasound-guided bilateral modified thoracolumbar interfascial plane (TLIP) block versus erector spinae (ES) block in optimizing early quality of recovery (QOR) following lumbar spine surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Modified Thoracolumbar Interfascial Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for elective lumbar spine fixation 2-3 levels.
- American Society of Anesthesiologists(ASA) class I-III.
Who cannot join
- 1. Obese patients (Body Mass Index> 35). 2. Patients with neurological deficits, cardiopulmonary disease, hepatic or renal impairment.
- 3. Patients with history of severe allergies to local anesthetics or other medications used during the procedure.
- 4. Patients with history of coagulation disorder or anticoagulants. 5. Patients with emergency surgeries or re-do surgeries. 6. Patients with systemic infections or infections at the site of injection. 7. Patients with Psychiatric illnesses. 8. Patients with history of drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
Aim of study The objective of the current study is to compare the efficacy of ultrasound-guided bilateral modified thoracolumbar interfascial plane (TLIP) block versus erector spinae (ES) block in optimizing early quality of recovery (QOR) following lumbar spine surgery under general anesthesia.
Read the detailed description
Lumbar spine surgery, a common surgical procedure to alleviate spinal stenosis or disc herniation, is often associated with significant postoperative pain that can hinder early recovery and patient satisfaction. Effective pain management is critical to improve the quality of recovery (QOR), reducing complications, and facilitating early mobilization (1). Regional anesthesia techniques, such as nerve blocks, have gained popularity as part of multimodal analgesia strategies to minimize opioid use and enhance postoperative outcomes. Among these, the thoracolumbar interfascial plane (TLIP) block and the erector spinae (ES) block have emerged as promising ultrasound-guided techniques for managing pain after lumbar spine surgeries (2).
- Conditions
- Low Back Pain
- Being tested
- Modified Thoracolumbar Interfascial Plane Block
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Thoracolumbar Interfascial Plane BlockProcedure or surgery
The TLIP block, introduced as a modification of the lumbar interfascial plane block, targets the dorsal rami of the thoracolumbar nerves by injecting local anesthetic into the fascial plane between the multifidus and longissimus muscles. This technique is designed to provide analgesia to the posterior elements of the spine, which are often the primary sources of pain after laminectomy
| Study group | Role | What they receive |
|---|---|---|
| Espb | Active comparator | Not described Receives: Procedure: Modified Thoracolumbar Interfascial Plane Block |
| Tlib | Active comparator | Not described Receives: Procedure: Modified Thoracolumbar Interfascial Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery (QOR)
Assessed using the QOR-15 questionnaire at 24 hours postoperatively
Measured: 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 posted11 Sep 2025
- Study start1 Jun 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed sayed Shaban, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166900
- Sponsor's protocol ID
- M800
- Status last verified
- May 2026
- First submitted
- 9 Sep 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Thoracolumbar Interfascial Plane Block Versus Erector Spinae Plane Block For Enhancement Of Quality of Recovery After Lumbar Spine Surgery: A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07166900
- Acronym / sponsor ID
- M800
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 11 Sep 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.
Aim of study The objective of the current study is to compare the efficacy of ultrasound-guided bilateral modified thoracolumbar interfascial plane (TLIP) block versus erector spinae (ES) block in optimizing early quality of recovery (QOR) following lumbar spine surgery under general anesthesia.
Detailed description
Lumbar spine surgery, a common surgical procedure to alleviate spinal stenosis or disc herniation, is often associated with significant postoperative pain that can hinder early recovery and patient satisfaction. Effective pain management is critical to improve the quality of recovery (QOR), reducing complications, and facilitating early mobilization (1). Regional anesthesia techniques, such as nerve blocks, have gained popularity as part of multimodal analgesia strategies to minimize opioid use and enhance postoperative outcomes. Among these, the thoracolumbar interfascial plane (TLIP) block and the erector spinae (ES) block have emerged as promising ultrasound-guided techniques for managing pain after lumbar spine surgeries (2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Espb | Active comparator | Procedure: Modified Thoracolumbar Interfascial Plane Block |
| Tlib | Active comparator | Procedure: Modified Thoracolumbar Interfascial Plane Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient scheduled for elective lumbar spine fixation 2-3 levels.
- American Society of Anesthesiologists(ASA) class I-III.
Key exclusion criteria (3 listed)
- 1. Obese patients (Body Mass Index> 35). 2. Patients with neurological deficits, cardiopulmonary disease, hepatic or renal impairment.
- 3. Patients with history of severe allergies to local anesthetics or other medications used during the procedure.
- 4. Patients with history of coagulation disorder or anticoagulants. 5. Patients with emergency surgeries or re-do surgeries. 6. Patients with systemic infections or infections at the site of injection. 7. Patients with Psychiatric illnesses. 8. Patients with history of drug addiction
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 Interfascial Plane BlockThe TLIP block, introduced as a modification of the lumbar interfascial plane block, targets the dorsal rami of the thoracolumbar nerves by injecting local anesthetic into the fascial plane between the multifidus and longissimus muscles. This technique is designed to provide analgesia to the posterior elements of the spine, which are often the primary sources of pain after laminectomy | Procedure or surgery | Espb, Tlib |
Primary outcome
Quality of Recovery (QOR)
Time frame: 24 hours postoperatively
Assessed using the QOR-15 questionnaire at 24 hours postoperatively
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 13 May 2026.
- 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 Interfascial Plane Block in people with Low Back Pain, run by Fayoum University at 1 site in Egypt.
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 2 inclusion and 3 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 13 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 Egypt. 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?
Quality of Recovery (QOR) (time frame: 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 13 May 2026.