Quadratus Lumborum BlockNCT07448987
Ultrasound Guided Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, and Local Anesthetic Infiltration for Lumbar Spine Fixation
A study testing Quadratus lumborum block, Thoracolumbar interfascial plane block and Local anesthetic infiltration in people with Quadratus Lumborum Block and Thoracolumbar Interfascial Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to compare the efficacy of ultrasound guided trans-muscular quadratus lumborum Block, thoracolumbar interfascial plane block and local anesthetic infiltration for elective lumbar spine fixation undergo up to three-level fixation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, Local Anesthetic Infiltration
- What is being tested?
- Quadratus lumborum block, Thoracolumbar interfascial plane block and Local anesthetic infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 30 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both genders.
- American Society of Anesthesiology (ASA) class I - II.
- Scheduled for elective lumbar spine fixation up to three level.
Who cannot join
- Patient refusal.
- History of allergy to local anesthetic.
- Mental dysfunction or cognitive disorders.
- Body Mass Index > 30 kg/m2.
- Coagulopathy.
- Pregnancy.
- Infections to the site of the block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Efficacy of Ultrasound Guided Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, and Local Anesthetic Infiltration for Lumbar Spine Fixation: Prospective Randomized Trial
This study aimed to compare the efficacy of ultrasound guided trans-muscular quadratus lumborum Block, thoracolumbar interfascial plane block and local anesthetic infiltration for elective lumbar spine fixation undergo up to three-level fixation.
Read the detailed description
Back and leg pain arising from lumbar spine surgery is widespread, and its treatment can range from pharmacotherapy to surgical intervention. A majority of patients who undergo spinal surgery report experiencing moderate pain six months after the operation.
Interfascial plane blocks, including the thoracolumbar interfascial plane (TLIP) block target these posterior rami passing through the paraspinal muscles. Several studies have explored the analgesic efficacy of TLIP block in posterior lumbar spine surgery.
Quadratus lumborum block (QLB) is a posterior abdominal wall fascial block where local anesthetic is administered around QL muscle. play a significant role in contemporary medical practice for enhancing post-spinal surgery pain management.
Local infiltrative analgesia applied in layers of the surgical wound layers has been suggested as an appealing alternative due to its simplicity, enhanced safety, and limited cost, also a popular modality for postoperative analgesia in spine surgery.
- Conditions
- Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, Local Anesthetic Infiltration, Lumbar Spine Fixation
- Being tested
- Quadratus lumborum block, Thoracolumbar interfascial plane block, Local anesthetic infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum blockOther
Patients received general anesthesia and bilateral ultrasound guided trans-muscular quadratus lumborum block (QLB 3) with (20 ml Bupivacaine 0.25% each side) + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg).
Thoracolumbar interfascial plane blockOther
Patients received general anesthesia and bilateral ultrasound guided thoracolumbar interfascial plane block with (20ml of Bupivacaine 0.25%) for each side + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg).
Local anesthetic infiltrationOther
Patients received general anesthesia and local anesthetic infiltration at the side of incision before with (40 ml of Bupivacaine 0.25%) + (Dexmedetomidine 1mic/kg).
| Study group | Role | What they receive |
|---|---|---|
| Group I: QLB group | Experimental | Patients received general anesthesia and bilateral ultrasound guided trans-muscular quadratus lumborum block (QLB 3) with (20 ml Bupivacaine 0.25% each side) + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg). Receives: Other: Quadratus lumborum block |
| Group II: TLIP block group | Experimental | Patients received general anesthesia and bilateral ultrasound guided thoracolumbar interfascial plane block with (20ml of Bupivacaine 0.25%) for each side + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg). Receives: Other: Thoracolumbar interfascial plane block |
| Group III: Local wound infiltration group | Experimental | Patients received general anesthesia and local anesthetic infiltration at the side of incision before with (40 ml of Bupivacaine 0.25%) + (Dexmedetomidine 1mic/kg). Receives: Other: Local anesthetic infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Intravenous morphine (0.05mg/kg) was given when numeric rating scale (NRS) equal or above 4.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Mean arterial pressure
Mean arterial pressure was recorded before induction of anesthesia (base-line value), after prone position, at the time of skin incision and after skin incision by 5,15 and 30 minutes, and at the end of the operation.
Measured: Till end of surgery (Up to 2 hours)
Heart rate
Heart rate was recorded before induction of anesthesia (base-line value), after prone position, at the time of skin incision and after skin incision by 5,15 and 30 minutes, and at the end of the operation.
Measured: Till end of surgery (Up to 2 hours)
Time to the first request for rescue analgesia
Time to the first request for rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.
Measured: 24 hours postoperatively
Degree of pain
Each patient was instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS were the 0th (PACU), 1th, 3rd, 6th, 12th, and 24th postoperative hours.
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 posted4 Mar 2026
- Study start1 Jul 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadratus Lumborum BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Fareed Elkot, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448987
- Sponsor's protocol ID
- 36264MS646/7/24
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Efficacy of Ultrasound Guided Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, and Local Anesthetic Infiltration for Lumbar Spine Fixation: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07448987
- Acronym / sponsor ID
- 36264MS646/7/24
- Conditions
- Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, Local Anesthetic Infiltration, Lumbar Spine Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 4 Mar 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 study aimed to compare the efficacy of ultrasound guided trans-muscular quadratus lumborum Block, thoracolumbar interfascial plane block and local anesthetic infiltration for elective lumbar spine fixation undergo up to three-level fixation.
Detailed description
Back and leg pain arising from lumbar spine surgery is widespread, and its treatment can range from pharmacotherapy to surgical intervention. A majority of patients who undergo spinal surgery report experiencing moderate pain six months after the operation.
Interfascial plane blocks, including the thoracolumbar interfascial plane (TLIP) block target these posterior rami passing through the paraspinal muscles. Several studies have explored the analgesic efficacy of TLIP block in posterior lumbar spine surgery.
Quadratus lumborum block (QLB) is a posterior abdominal wall fascial block where local anesthetic is administered around QL muscle. play a significant role in contemporary medical practice for enhancing post-spinal surgery pain management.
Local infiltrative analgesia applied in layers of the surgical wound layers has been suggested as an appealing alternative due to its simplicity, enhanced safety, and limited cost, also a popular modality for postoperative analgesia in spine surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I: QLB group | Experimental | Other: Quadratus lumborum blockPatients received general anesthesia and bilateral ultrasound guided trans-muscular quadratus lumborum block (QLB 3) with (20 ml Bupivacaine 0.25% each side) + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg). |
| Group II: TLIP block group | Experimental | Other: Thoracolumbar interfascial plane blockPatients received general anesthesia and bilateral ultrasound guided thoracolumbar interfascial plane block with (20ml of Bupivacaine 0.25%) for each side + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg). |
| Group III: Local wound infiltration group | Experimental | Other: Local anesthetic infiltrationPatients received general anesthesia and local anesthetic infiltration at the side of incision before with (40 ml of Bupivacaine 0.25%) + (Dexmedetomidine 1mic/kg). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both genders.
- American Society of Anesthesiology (ASA) class I - II.
- Scheduled for elective lumbar spine fixation up to three level.
Key exclusion criteria (7 listed)
- Patient refusal.
- History of allergy to local anesthetic.
- Mental dysfunction or cognitive disorders.
- Body Mass Index > 30 kg/m2.
- Coagulopathy.
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 |
|---|---|---|
| Quadratus lumborum blockPatients received general anesthesia and bilateral ultrasound guided trans-muscular quadratus lumborum block (QLB 3) with (20 ml Bupivacaine 0.25% each side) + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg). | Other | Group I: QLB group |
| Thoracolumbar interfascial plane blockPatients received general anesthesia and bilateral ultrasound guided thoracolumbar interfascial plane block with (20ml of Bupivacaine 0.25%) for each side + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg). | Other | Group II: TLIP block group |
| Local anesthetic infiltrationPatients received general anesthesia and local anesthetic infiltration at the side of incision before with (40 ml of Bupivacaine 0.25%) + (Dexmedetomidine 1mic/kg). | Other | Group III: Local wound infiltration group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Intravenous morphine (0.05mg/kg) was given when numeric rating scale (NRS) equal or above 4.
4 secondary outcomes
Mean arterial pressure
Time frame: Till end of surgery (Up to 2 hours)
Heart rate
Time frame: Till end of surgery (Up to 2 hours)
Time to the first request for rescue analgesia
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 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 4 Mar 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Quadratus lumborum block, Thoracolumbar interfascial plane block and Local anesthetic infiltration in people with Quadratus Lumborum Block and Thoracolumbar Interfascial Plane Block, run by Tanta 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 4 inclusion and 7 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 4 Mar 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?
Total morphine consumption (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 4 Mar 2026.