Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine DiscectomyNCT06910696
Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block
A study testing Regional Anesthetic Injection in people with Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine Discectomy, run by Zagazig University at 1 site in Egypt.
Trial summary
the purpose of this study is to compare of better postoperative analgesia following lumber spine discectomy Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine Discectomy
- What is being tested?
- Regional Anesthetic Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2025to 1 Dec 2025
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent from the patient.
- Physical status: ASA 1\& II.
- BMI = (25-30 kg/m2).
- Type of operation: elective Lumbar discectomy .
Who cannot join
- Altered mental state.
- Patients with known history of allergy to study drugs.
- Advanced hepatic, renal, cardiovascular, and respiratory diseases.
- Patients with chronic pain.
- Patients receiving anticoagulants.
- Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
faculty of medicine,zagazig university Egypt Ext. 002 K.Howida@yahoo.com
Zagazig, 44519
About this study
Official title: Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block for Rapid Recovery and Rehabilitation After Lumber Discectomy: A Randomized Study
the purpose of this study is to compare of better postoperative analgesia following lumber spine discectomy
- Conditions
- Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine Discectomy
- Being tested
- Regional Anesthetic Injection
- Keywords
- erector spinae plane block modified thoracolumbar interfascial plane block perioperative analgesia lumber spine discectomy?
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional Anesthetic InjectionDrug
The probe will be placed in the parasagittal plane at the level of the L3 vertebrae. The spinous process will be visualized, and the probe was moved 3 cm laterally from the midline. The erector spinae musclewill be visualized above the transverse process. The needle will be punctured in the craniocaudal direction using the in-plane technique. The needle will be directed superior to the transverse process . Then, 2 mL normal saline solution will be injected into the deep fascia of the erector spinae muscle to confirm the proper injection site. After ensuring the location of the needle, 20 mL of 0.25% bupivacaine will be administered. The same ESPB procedure will be performed on the other side. In total, 40 mL of 0.25% bupivacaine was administered
Regional Anesthetic InjectionDrug
The probe will be placed vertically at the L3 vertebrae level. The spinous process and the interspinous muscles (i.e., multifidus, longissimus, and iliocostalis) will be visualized as the anatomic guide points. The probewill be moved laterally to identify the longissimus and iliocostalis muscles . The needlewill be inserted between the longissimus and iliocostalis in the medial-to-lateral direction using the in-plane technique. After confirming the location of the needle, 20 mL of 0.25% bupivacaine will be administered. The same mTLIP procedure will be performed on the opposite side. In total, 40 mL of 0.25% bupivacaine will be administered
| Study group | Role | What they receive |
|---|---|---|
| • Control Group | No intervention | Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv. |
| (mTLIP )Group | Active comparator | Patients will receive 20 mL of 0.25% bupivacaine on each side through Modified thoracolumbar interfascial block Receives: Drug: Regional Anesthetic Injection |
| (ESPB) Group | Active comparator | Patients will receive 20 mL of 0.25% bupivacaine on each side through Erector spinae block Receives: Drug: Regional Anesthetic Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
from the day of admission till discharge from hospital
Measured: up to 1 weak postoperative.
Secondary outcomes (8)
The recovery time
time from discontinuation of isoflurane to first response to verbal command
Measured: up to 30 minutes postoperative.
The time of discharge
The time from arrival to the PACU to discharge to the ward
Measured: up to 2 hours postoperative.
6 minutes walk test
involves walking for 6 min on a 30 m walking path and measuring the distance
Measured: 24 hours postoperative
Functional reach test
quantifies participants' dynamic in-place standing balance control to reach distance. The distance between the starting and maximal forward reach distance beyond the participant's arm length represents the reach distance and is recorded in centimeters
Measured: 24 hours postoperative
Time up and go test
objective measure of functional disability that can be used to evaluate various activities such as standing, accelerating, walking, decelerating, and turning, which are often limited in patients with lumbar degenerative diseases
Measured: 24 hours postoperative
Pain intensity
10-point NRS [(0 = no pain, 10 = worst imaginable pain), 1 - 3: Mild pain (nagging, annoying, slightly interfering with activities of daily living (ADLs), 4 - 6: Moderate pain (significantly interfering with ADLs, 7 - 10: Severe pain (disabling, unable to perform ADLs)]
Measured: 30 minutes after the end of the surgery, as well as 3, 6, 12, and 24 hours postoperatively
Time to first call analgesia
Measured: 24 hours postoperative
Total naluphine consumption
Measured: 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start11 Apr 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine DiscectomyStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910696
- Sponsor's protocol ID
- ZU-IRB#1074/25-Feb-2025
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block for Rapid Recovery and Rehabilitation After Lumber Discectomy: A Randomized Study
- ClinicalTrials.gov ID
- NCT06910696
- Acronym / sponsor ID
- ZU-IRB#1074/25-Feb-2025
- Conditions
- Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine Discectomy
- Keywords
- erector spinae plane block modified thoracolumbar interfascial plane block perioperative analgesia lumber spine discectomy?
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Apr 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.
the purpose of this study is to compare of better postoperative analgesia following lumber spine discectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| • Control Group | No intervention | –Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv. |
| (mTLIP )Group | Active comparator | Drug: Regional Anesthetic InjectionPatients will receive 20 mL of 0.25% bupivacaine on each side through Modified thoracolumbar interfascial block |
| (ESPB) Group | Active comparator | Drug: Regional Anesthetic InjectionPatients will receive 20 mL of 0.25% bupivacaine on each side through Erector spinae block |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent from the patient.
- Physical status: ASA 1\& II.
- BMI = (25-30 kg/m2).
- Type of operation: elective Lumbar discectomy .
Key exclusion criteria (6 listed)
- Altered mental state.
- Patients with known history of allergy to study drugs.
- Advanced hepatic, renal, cardiovascular, and respiratory diseases.
- Patients with chronic pain.
- Patients receiving anticoagulants.
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 |
|---|---|---|
| Regional Anesthetic InjectionThe probe will be placed in the parasagittal plane at the level of the L3 vertebrae. The spinous process will be visualized, and the probe was moved 3 cm laterally from the midline. The erector spinae musclewill be visualized above the transverse process. The needle will be punctured in the craniocaudal direction using the in-plane technique. The needle will be directed superior to the transverse process . Then, 2 mL normal saline solution will be injected into the deep fascia of the erector spinae muscle to confirm the proper injection site. After ensuring the location of the needle, 20 mL of 0.25% bupivacaine will be administered. The same ESPB procedure will be performed on the other side. In total, 40 mL of 0.25% bupivacaine was administered | Drug | (ESPB) Group |
| Regional Anesthetic InjectionThe probe will be placed vertically at the L3 vertebrae level. The spinous process and the interspinous muscles (i.e., multifidus, longissimus, and iliocostalis) will be visualized as the anatomic guide points. The probewill be moved laterally to identify the longissimus and iliocostalis muscles . The needlewill be inserted between the longissimus and iliocostalis in the medial-to-lateral direction using the in-plane technique. After confirming the location of the needle, 20 mL of 0.25% bupivacaine will be administered. The same mTLIP procedure will be performed on the opposite side. In total, 40 mL of 0.25% bupivacaine will be administered | Drug | (mTLIP )Group |
Primary outcome
Length of hospital stay
Time frame: up to 1 weak postoperative.
from the day of admission till discharge from hospital
8 secondary outcomes
The recovery time
Time frame: up to 30 minutes postoperative.
The time of discharge
Time frame: up to 2 hours postoperative.
6 minutes walk test
Time frame: 24 hours postoperative
Functional reach test
Time frame: 24 hours postoperative
Time up and go test
Time frame: 24 hours postoperative
Pain intensity
Time frame: 30 minutes after the end of the surgery, as well as 3, 6, 12, and 24 hours postoperatively
Time to first call analgesia
Time frame: 24 hours postoperative
Total naluphine consumption
Time frame: 24 hours post-operative
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 15 Apr 2025.
- https://pubmed.ncbi.nlm.nih.gov/29318534/Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
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 Regional Anesthetic Injection in people with Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine Discectomy, run by Zagazig 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 6 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: enrolling by invitation, as of the sponsor's last update on 15 Apr 2025. 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?
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?
Length of hospital stay (time frame: up to 1 weak postoperative.). 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 15 Apr 2025.