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Postoperative Pain After Spinal SurgeryNCT07883616

Modified Thoracolumbar Interfascial Plane Block vs Retrolaminar Block for Pain in Lumbar Spine Surgeries

A study testing Morphine, Bupivacaine and Dexamethasone in people with Postoperative Pain After Spinal Surgery, run by Zagazig University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective randomized double-blind study aims to compare the efficacy of modified Thoracolumbar Interfascial Plane (mTLIP) block versus Retrolaminar block for postoperative pain control in patients undergoing elective two-level lumbar spine surgeries. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Postoperative Pain After Spinal Surgery
What is being tested?
Morphine, Bupivacaine and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteEgypt
Study dates
1 Oct 2025to 1 Jan 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 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 21 and 65 years
  • ASA physical status I or II
  • BMI < 30 kg/m²
  • Scheduled for elective two-level lumbar spine surgery (discectomy/decompression)
  • Expected duration of surgery less than 3 hours
  • Patient's acceptance and written informed consent

Who cannot join

  • Infection at block site
  • Known allergy to used drugs
  • Coagulation disorder
  • History of psychiatric illness
  • Pre-existing neurological deficits
  • Presence of any metastasis
  • Previous lumbar spine surgeries
  • Patients on previous opioid therapy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohamed Shehta Mohamed Ali contact

+2001014634299

m.shehta025@medicine.zu.edu.eg

Egypt1 site, 1 recruiting

  • Zagazig University Hospitals, Anesthesia, Intensive Care and Pain Management Department

    Zagazig, Sharqia Province, 44519

    Mohamed Shehta Mohamed Ali, M.B.B.CH, +2001014634299, m.shehta025@medicine.zu.edu.eg

    Mohamed Shehta, M.B.B.CH

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Modified Thoracolumbar Interfascial Plane Block Versus Retrolaminar Block for Pain Control in Postoperative Lumbar Spine Surgeries: A Prospective Randomized Double-Blind Clinical Study

This prospective randomized double-blind study aims to compare the efficacy of modified Thoracolumbar Interfascial Plane (mTLIP) block versus Retrolaminar block for postoperative pain control in patients undergoing elective two-level lumbar spine surgeries. The primary outcome is total morphine consumption in the first 24 postoperative hours.

Read the detailed description

Pain after lumbar spine surgery arises from disruption of paraspinal muscles, ligaments, and bony structures, with innervation from dorsal rami of spinal nerves. Opioids remain the cornerstone of postoperative analgesia but carry adverse effects. The mTLIP block targets the fascial plane between longissimus and iliocostalis muscles, while the Retrolaminar block deposits local anesthetic on the posterior surface of the vertebral lamina. Both target the dorsal rami. This study will compare both techniques regarding opioid consumption, pain scores, time to first rescue analgesia, block performance metrics, side effects, functional recovery, and patient satisfaction.

Being tested
Morphine, Bupivacaine, Dexamethasone, Magnesium Sulphate, Modified Thoracolumbar Interfascial Plane Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MorphineDrug

    Also called Morphine Sulfate

    Rescue analgesic administered intravenously at a dose of 0.1-0.2 mg/kg every 2-4 hours as needed for breakthrough pain (NRS > 3), with a maximum dose of 10 mg per administration.

  • BupivacaineDrug

    Also called Bupivacaine Hydrochloride

    Local anesthetic used in the block solution (0.25%, 15 mL per side).

  • DexamethasoneDrug

    Also called Dexamethasone Sodium Phosphate

    Adjuvant added to the block solution (8 mg per side) to prolong analgesia.

  • Magnesium SulphateDrug

    Also called Magnesium Sulfate

    Adjuvant added to the block solution (300 mg of 10% per side) to prolong analgesia.

  • Modified Thoracolumbar Interfascial Plane BlockProcedure or surgery

    Also called mTLIP Block

    Ultrasound-guided injection between the longissimus and iliocostalis muscles at the L3 level.

  • Retrolaminar BlockProcedure or surgery

    Also called RLB

    Ultrasound-guided injection on the posterior surface of the vertebral lamina at the L3 level, deep to the erector spinae muscles.

Study groups in NCT07883616
Study groupRoleWhat they receive
Modified Thoracolumbar Interfascial Plane (mTLIP) BlockExperimentalPreoperative ultrasound-guided mTLIP block at L3 level with 20 mL injectate (Bupivacaine 0.25% 15 mL + dexamethasone 8 mg + magnesium sulphate 300 mg per side), followed by standardized general anesthesia.
Receives: Drug: Morphine; Drug: Bupivacaine; Drug: Dexamethasone; Drug: Magnesium Sulphate; Procedure: Modified Thoracolumbar Interfascial Plane Block
Retrolaminar BlockActive comparatorPreoperative ultrasound-guided retrolaminar block at L3 level with the same 20 mL injectate composition per side, followed by standardized general anesthesia.
Receives: Drug: Morphine; Drug: Bupivacaine; Drug: Dexamethasone; Drug: Magnesium Sulphate; Procedure: Retrolaminar Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total morphine consumption in the first 24 hours postoperatively

    Cumulative morphine dose (mg) administered as rescue analgesia during the first 24 postoperative hours

    Measured: 24 hours postoperatively

Secondary outcomes (8)

  1. Pain intensity by Numerical Rating Scale (NRS)

    Pain intensity assessed using a 10-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable)

    Measured: At 2, 4, 8, 12, 18, and 24 hours postoperatively

  2. Time to first rescue analgesia

    Time from local anesthetic injection until the patient first requests additional pain-relieving medication (NRS > 3)

    Measured: First 24 hours postoperatively

  3. Block performance time

    Time required to perform the block procedure

    Measured: During block procedure

  4. Onset of sensory block

    Time from local anesthetic injection until loss of sensation in the desired dermatomes

    Measured: Within 20-30 minutes after injection

  5. Opioid-related side effects

    Incidence of postoperative nausea and vomiting (PONV) assessed by PONV impact scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), sedation, and respiratory depression

    Measured: 24 hours postoperatively

  6. Patient satisfaction score

    Patient satisfaction assessed using a 4-point scale (4 = excellent, 3 = good, 2 = fair, 1 = poor)

    Measured: 24 hours postoperatively

  7. Incidence of chronic pain

    Chronic pain will be assessed at 3 months postoperatively via a structured follow-up (telephone interview or outpatient clinic visit). Patients will be asked whether they experience persistent or recurrent pain at or around the surgical site lasting more than 3 months after surgery. Responses will be recorded as "Yes" or "No," and the proportion of patients answering "Yes" will be reported as the incidence of chronic pain, according to the IASP definition (pain persisting or recurring for more than 3 months).

    Measured: 3 to 6 months postoperatively

  8. Time of ambulation

    Time to first mobilization after surgery

    Measured: First 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study start1 Oct 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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 are randomized into two parallel groups. Group M receives modified Thoracolumbar Interfascial Plane block, and Group R receives Retrolaminar block, both followed by standardized general anesthesia.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07883616
Sponsor's protocol ID
1717-28-9-2025
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to privacy and ethical restrictions.

Publications

  • Klimek M, Ubben JF, Ammann J, Borner U, Klein J, Verbrugge SJ. Pain in neurosurgically treated patients: a prospective observational study. J Neurosurg. 2006 Mar;104(3):350-9. doi: 10.3171/jns.2006.104.3.350.

    PubMed 16572646

  • Patel TD, McNicholas MN, Paschell PA, Arnold PM, Lee CT. Thoracolumbar Interfascial Plane (TLIP) block verses other paraspinal fascial plane blocks and local infiltration for enhanced pain control after spine surgery: a systematic review. BMC Anesthesiol. 2024 Mar 28;24(1):122. doi: 10.1186/s12871-024-02500-1.

    PubMed 38539065

  • Kamel AAF, Fahmy AM, Medhat MM, Ali Elmesallamy WAE, Salem DAE. Retrolaminar block for opioid-free anaesthesia and enhanced recovery after posterior lumbar discectomy: A randomised controlled study. Indian J Anaesth. 2024 Mar;68(3):261-266. doi: 10.4103/ija.ija_773_23. Epub 2024 Feb 22.

    PubMed 38476544

  • Pfeiffer G, Oppitz N, Schone S, Richter-Heine I, Hohne M, Koltermann C. [Analgesia of the axilla using a paravertebral catheter in the lamina technique]. Anaesthesist. 2006 Apr;55(4):423-7. doi: 10.1007/s00101-005-0969-0. German.

    PubMed 16404582

  • Ahiskalioglu A, Yayik AM, Doymus O, Selvitopi K, Ahiskalioglu EO, Calikoglu C, Alici HA, Karaca O. Efficacy of ultrasound-guided modified thoracolumbar interfascial plane block for postoperative analgesia after spinal surgery: a randomized-controlled trial. Can J Anaesth. 2018 May;65(5):603-604. doi: 10.1007/s12630-018-1051-0. Epub 2018 Jan 9. No abstract available.

    PubMed 29318534

  • Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.

    PubMed 26149600

Questions about this trial

What is this clinical trial studying?

A study testing Morphine, Bupivacaine and Dexamethasone in people with Postoperative Pain After Spinal Surgery, 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 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: looking for participants now, as of the sponsor's last update on 20 Oct 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 Mohamed Shehta Mohamed Ali (+2001014634299, m.shehta025@medicine.zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total morphine consumption in the first 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?

On the ClinicalTrials.gov record for NCT07883616, which also lists 6 linked publications.

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 20 Oct 2026.

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