Postoperative PainTLIP-RLB-QoRNCT07609212
TLIP Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery
A study testing Thoracolumbar interfascial plane block and Retrolaminar block in people with Postoperative Pain and Spinal Fusion Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
This prospective randomized controlled study aims to compare the effects of ultrasound-guided thoracolumbar interfascial plane (TLIP) block versus retrolaminar block on postoperative quality of recovery in patients undergoing posterior lumbar spine fusion surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Spinal Fusion Surgery, Degenerative Lumbar Spine Diseases
- What is being tested?
- Thoracolumbar interfascial plane block and Retrolaminar block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2026to Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-65 years
- Male and female patients
- Scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia
- ASA physical status I-III
- BMI < 35 kg/m²
- Willing to participate and provide informed consent
Who cannot join
- Patient refusal to participate
- Coagulopathy or anticoagulant therapy
- Infection at the site of block injection
- Known allergy to local anesthetics
- Chronic opioid use (>3 months)
- Severe hepatic, renal, or cardiac dysfunction
- Neurological deficits interfering with pain assessment
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Thoracolumbar Interfascial Plane Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery: A Prospective Randomized Controlled Trial
This prospective randomized controlled study aims to compare the effects of ultrasound-guided thoracolumbar interfascial plane (TLIP) block versus retrolaminar block on postoperative quality of recovery in patients undergoing posterior lumbar spine fusion surgery. Despite advances in surgical techniques, lumbar spine fusion is associated with significant postoperative pain, which may delay recovery and increase opioid consumption.
Recent approaches emphasize multimodal analgesia and opioid-sparing strategies, including regional anesthesia techniques. Interfascial plane blocks, such as TLIP and retrolaminar block, have gained attention due to their safety and effectiveness in targeting the dorsal rami of spinal nerves supplying the posterior spinal structures.
The primary outcome of this study is postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to ambulation, time to oral intake, and postoperative complications.
Read the detailed description
This study is a prospective, randomized, controlled, double-blind clinical trial conducted at Assiut University Hospital. A total of 70 adult patients scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia will be enrolled and randomly allocated into two equal groups.
Patients in Group T will receive ultrasound-guided thoracolumbar interfascial plane (TLIP) block, while patients in Group R will receive ultrasound-guided retrolaminar block. All blocks will be performed after induction of general anesthesia under strict aseptic precautions by an experienced anesthesiologist.
Randomization will be performed using a computer-generated sequence with allocation concealment via sequentially numbered, opaque, sealed envelopes. The study will be conducted in a double-blind manner, where patients and outcome assessors will be blinded to group allocation.
All patients will receive standardized perioperative care based on enhanced recovery principles, including multimodal analgesia and early mobilization. Postoperative pain will be assessed using the Visual Analog Scale (VAS), and rescue analgesia will be administered when needed.
The primary outcome is the QoR-15 score at 24 hours postoperatively. Secondary outcomes include pain scores at predefined intervals, time to first rescue analgesia, total opioid consumption, time to ambulation, time to oral intake, length of hospital stay, and incidence of postoperative complications.
- Being tested
- Thoracolumbar interfascial plane block, Retrolaminar block
- Keywords
- TLIP Block, Retrolaminar Block, Regional Anesthesia, Quality of Recovery, QoR-15, Lumbar Spine Surgery, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbar interfascial plane blockProcedure or surgery
Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level
Retrolaminar blockProcedure or surgery
Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.
| Study group | Role | What they receive |
|---|---|---|
| Thoracolumbar interfascial plane Block Group | Experimental | Patients will receive ultrasound-guided thoracolumbar interfascial plane block after induction of general anesthesia. Receives: Procedure: Thoracolumbar interfascial plane block |
| Retrolaminar Block Group | Experimental | Patients will receive ultrasound-guided retrolaminar block after induction of general anesthesia. Receives: Procedure: Retrolaminar block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a validated 15-item patient-reported outcome measure. Scores range from 0 to 150, with higher scores indicating better postoperative recovery. The primary endpoint is the QoR-15 score at 24 hours after surgery.
Measured: 24 hours postoperatively
Secondary outcomes (7)
Pain intensity using Visual Analog Scale (VAS)
Pain will be assessed using a 0-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: 30 minutes, 2, 6, 12, and 24 hours postoperatively
Time to first rescue analgesia
Time from the end of surgery to the first request for rescue analgesia (VAS ≥ 4).
Measured: Within 24 hours postoperatively
Total nalbuphine consumption
Total amount of nalbuphine administered within the first 24 hours after surgery (mg).
Measured: 24 hours postoperatively
Time to first ambulation
Measured: From end of surgery to first ambulation, assessed up to 48 hours postoperatively
Time to tolerate oral intake
Measured: From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
Length of hospital stay
Measured: From surgery until hospital discharge, assessed up to 7 days postoperatively
Incidence of postoperative complications
Includes nausea, vomiting, pruritus, hypotension, bradycardia, hematoma, infection, and local anesthetic systemic toxicity (LAST).
Measured: Within 24-48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: TLIP block group or retrolaminar block group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Mostafa Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609212
- Sponsor's protocol ID
- TLIP-RLB-QoR-2026
- Acronym
- TLIP-RLB-QoR
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracolumbar Interfascial Plane Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07609212
- Acronym / sponsor ID
- TLIP-RLB-QoR / TLIP-RLB-QoR-2026
- Keywords
- TLIP Block, Retrolaminar Block, Regional Anesthesia, Quality of Recovery, QoR-15, Lumbar Spine Surgery, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 May 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.
This prospective randomized controlled study aims to compare the effects of ultrasound-guided thoracolumbar interfascial plane (TLIP) block versus retrolaminar block on postoperative quality of recovery in patients undergoing posterior lumbar spine fusion surgery. Despite advances in surgical techniques, lumbar spine fusion is associated with significant postoperative pain, which may delay recovery and increase opioid consumption.
Recent approaches emphasize multimodal analgesia and opioid-sparing strategies, including regional anesthesia techniques. Interfascial plane blocks, such as TLIP and retrolaminar block, have gained attention due to their safety and effectiveness in targeting the dorsal rami of spinal nerves supplying the posterior spinal structures.
The primary outcome of this study is postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to ambulation, time to oral intake, and postoperative complications.
Detailed description
This study is a prospective, randomized, controlled, double-blind clinical trial conducted at Assiut University Hospital. A total of 70 adult patients scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia will be enrolled and randomly allocated into two equal groups.
Patients in Group T will receive ultrasound-guided thoracolumbar interfascial plane (TLIP) block, while patients in Group R will receive ultrasound-guided retrolaminar block. All blocks will be performed after induction of general anesthesia under strict aseptic precautions by an experienced anesthesiologist.
Randomization will be performed using a computer-generated sequence with allocation concealment via sequentially numbered, opaque, sealed envelopes. The study will be conducted in a double-blind manner, where patients and outcome assessors will be blinded to group allocation.
All patients will receive standardized perioperative care based on enhanced recovery principles, including multimodal analgesia and early mobilization. Postoperative pain will be assessed using the Visual Analog Scale (VAS), and rescue analgesia will be administered when needed.
The primary outcome is the QoR-15 score at 24 hours postoperatively. Secondary outcomes include pain scores at predefined intervals, time to first rescue analgesia, total opioid consumption, time to ambulation, time to oral intake, length of hospital stay, and incidence of postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: TLIP block group or retrolaminar block group.
| Arm | Type | Receives |
|---|---|---|
| Thoracolumbar interfascial plane Block Group | Experimental | Procedure: Thoracolumbar interfascial plane blockPatients will receive ultrasound-guided thoracolumbar interfascial plane block after induction of general anesthesia. |
| Retrolaminar Block Group | Experimental | Procedure: Retrolaminar blockPatients will receive ultrasound-guided retrolaminar block after induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients aged 18-65 years
- Male and female patients
- Scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia
- ASA physical status I-III
- BMI < 35 kg/m²
Key exclusion criteria (8 listed)
- Patient refusal to participate
- Coagulopathy or anticoagulant therapy
- Infection at the site of block injection
- Known allergy to local anesthetics
- Chronic opioid use (>3 months)
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 |
|---|---|---|
| Thoracolumbar interfascial plane blockUltrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level | Procedure or surgery | Thoracolumbar interfascial plane Block Group |
| Retrolaminar blockUltrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level. | Procedure or surgery | Retrolaminar Block Group |
Primary outcome
Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively
Time frame: 24 hours postoperatively
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a validated 15-item patient-reported outcome measure. Scores range from 0 to 150, with higher scores indicating better postoperative recovery. The primary endpoint is the QoR-15 score at 24 hours after surgery.
7 secondary outcomes
Pain intensity using Visual Analog Scale (VAS)
Time frame: 30 minutes, 2, 6, 12, and 24 hours postoperatively
Time to first rescue analgesia
Time frame: Within 24 hours postoperatively
Total nalbuphine consumption
Time frame: 24 hours postoperatively
Time to first ambulation
Time frame: From end of surgery to first ambulation, assessed up to 48 hours postoperatively
Time to tolerate oral intake
Time frame: From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
Length of hospital stay
Time frame: From surgery until hospital discharge, assessed up to 7 days postoperatively
Incidence of postoperative complications
Time frame: Within 24-48 hours postoperatively
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 27 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracolumbar interfascial plane block and Retrolaminar block in people with Postoperative Pain and Spinal Fusion Surgery, run by Assiut 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 6 inclusion and 8 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 27 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?
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 Rehab Mohamed Mostafa Mahmoud, MD (Candidate) (+201063303791, rehab.mohamed19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively (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 27 May 2026.