Retrolaminar BlockNCT06725680
Retrolaminar Block Versus Erector Spinae Plane Block as Opioid-Free Anesthesia for Enhanced Recovery After Posterior Lumbar Discectomy
A study testing Retrolaminar block and Erector spinae plane block in people with Retrolaminar Block and Erector Spinae Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare retrolaminar block and erector spine plane block as opioid-free anesthesia for enhanced recovery after posterior lumbar discectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Retrolaminar Block, Erector Spinae Plane Block, Opioid-Free Anesthesia
- What is being tested?
- Retrolaminar block and Erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Dec 2024to 7 Oct 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 sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Undergoing elective posterior lumbar discectomy under general anesthesia.
Who cannot join
- Body mass index (BMI) >35 kg/m2.
- Patients with disturbed mental status.
- Allergies to the drugs used in the study.
- Local infection at the puncture site.
- Cardiac insufficiency.
- Renal insufficiency.
- Coagulopathy.
- Chronic opioid use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrolaminar Block Versus Erector Spinae Plane Block as Opioid-Free Anesthesia for Enhanced Recovery After Posterior Lumbar Discectomy: A Randomized Trial
The aim of this study is to compare retrolaminar block and erector spine plane block as opioid-free anesthesia for enhanced recovery after posterior lumbar discectomy.
Read the detailed description
Lumbar discectomy is a common procedure for patients who experience leg and back pain due to disc problems. Effective pain management is crucial for timely discharge and successful rehabilitation.
Opioid-free anesthesia is a technique that avoids the use of opioids during surgery. Enhanced recovery after surgery (ERAS) pathways are helpful strategies for incorporating opioid-free pain management techniques into clinical practice.
Erector spine plane block (ESPB) and retrolaminar block (RLB) are considered to be compartment blocks or interfacial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space.
- Conditions
- Retrolaminar Block, Erector Spinae Plane Block, Opioid-Free Anesthesia, Enhanced Recovery, Lumbar Discectomy
- Being tested
- Retrolaminar block, Erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrolaminar blockOther
Patients will receive retrolaminar block after the induction of general anesthesia.
Erector spinae plane blockOther
Patients will receive erector spinae plane block after the induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Retrolaminar block group | Experimental | Patients will receive retrolaminar block after the induction of general anesthesia. Receives: Other: Retrolaminar block |
| Erector spinae plane block group | Experimental | Patients will receive erector spinae plane block after the induction of general anesthesia. Receives: Other: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the 1st rescue analgesia
Time from end of surgery to first dose of morphine administrated.
Measured: 24 hours postoperatively
Secondary outcomes (7)
Recovery time
Time from isoflurane discontinuation to the first response to verbal command
Measured: Till first response to verbal command (Up to 1 hour)
Time to discharge
Time from admission to the post-anesthesia care unit (PACU) to discharge from the PACU when the Aldrete score is ≥9) will be recorded.
Measured: Till the Aldrete score is ≥9 (Up to 3 hours)
Intraoperative fentanyl consumption
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Measured: Intraoperatively
Total morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4. NRS will be assessed at 0, 4, 6, 8, 12, 18, and 24 h postoperatively.
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 24 hours postoperatively
Length of hospital stay
Length of hospital stay will be recorded from the admission till discharge from hospital.
Measured: Till discharge from hospital (Up to 1 week)
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication related to the block such as pleural perforation, hematoma, and intraspinal diffusion will be recorded.
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 posted10 Dec 2024
- Study start11 Dec 2024
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrolaminar 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725680
- Sponsor's protocol ID
- 36264PR936/11/24
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2024
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrolaminar Block Versus Erector Spinae Plane Block as Opioid-Free Anesthesia for Enhanced Recovery After Posterior Lumbar Discectomy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06725680
- Acronym / sponsor ID
- 36264PR936/11/24
- Conditions
- Retrolaminar Block, Erector Spinae Plane Block, Opioid-Free Anesthesia, Enhanced Recovery, Lumbar Discectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 10 Dec 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.
The aim of this study is to compare retrolaminar block and erector spine plane block as opioid-free anesthesia for enhanced recovery after posterior lumbar discectomy.
Detailed description
Lumbar discectomy is a common procedure for patients who experience leg and back pain due to disc problems. Effective pain management is crucial for timely discharge and successful rehabilitation.
Opioid-free anesthesia is a technique that avoids the use of opioids during surgery. Enhanced recovery after surgery (ERAS) pathways are helpful strategies for incorporating opioid-free pain management techniques into clinical practice.
Erector spine plane block (ESPB) and retrolaminar block (RLB) are considered to be compartment blocks or interfacial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrolaminar block group | Experimental | Other: Retrolaminar blockPatients will receive retrolaminar block after the induction of general anesthesia. |
| Erector spinae plane block group | Experimental | Other: Erector spinae plane blockPatients will receive erector spinae plane block after the 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 (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Undergoing elective posterior lumbar discectomy under general anesthesia.
Key exclusion criteria (8 listed)
- Body mass index (BMI) >35 kg/m2.
- Patients with disturbed mental status.
- Allergies to the drugs used in the study.
- Local infection at the puncture site.
- Cardiac insufficiency.
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 |
|---|---|---|
| Retrolaminar blockPatients will receive retrolaminar block after the induction of general anesthesia. | Other | Retrolaminar block group |
| Erector spinae plane blockPatients will receive erector spinae plane block after the induction of general anesthesia. | Other | Erector spinae plane block group |
Primary outcome
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Time from end of surgery to first dose of morphine administrated.
7 secondary outcomes
Recovery time
Time frame: Till first response to verbal command (Up to 1 hour)
Time to discharge
Time frame: Till the Aldrete score is ≥9 (Up to 3 hours)
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Total morphine consumption
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Length of hospital stay
Time frame: Till discharge from hospital (Up to 1 week)
Incidence of adverse events
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 19 Nov 2025.
- 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 Retrolaminar block and Erector spinae plane block in people with Retrolaminar Block and Erector Spinae 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 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: finished, as of the sponsor's last update on 19 Nov 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?
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?
Time to the 1st rescue analgesia (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 19 Nov 2025.