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

NCT07883616 — Not applicable, Recruiting, 42 participants, Zagazig University

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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

RegistryNCT07883616
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment42 (Estimated)
SponsorZagazig University (Other gov)
ConditionsPostoperative Pain After Spinal Surgery
InterventionsMorphine, Bupivacaine, Dexamethasone, Magnesium Sulphate, Modified Thoracolumbar Interfascial Plane Block, Retrolaminar Block (Drug, procedure)
Datesstart 2025-10-01, primary completion 2026-12-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-10-20, last updated 2026-10-20
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Pain After Spinal Surgery All trials of Morphine All trials of Bupivacaine

-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. The primary outcome is total morphine consumption in the first 24 postoperative hours.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Modified Thoracolumbar Interfascial Plane (mTLIP) BlockExperimentalDrug: Morphine; Drug: Bupivacaine; Drug: Dexamethasone; Drug: Magnesium Sulphate; Procedure: Modified Thoracolumbar Interfascial Plane BlockPreoperative 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.
Retrolaminar BlockActive comparatorDrug: Morphine; Drug: Bupivacaine; Drug: Dexamethasone; Drug: Magnesium Sulphate; Procedure: Retrolaminar BlockPreoperative ultrasound-guided retrolaminar block at L3 level with the same 20 mL injectate composition per side, followed by standardized general anesthesia.
  • Morphine (Drug), also known as 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.
  • Bupivacaine (Drug), also known as Bupivacaine Hydrochloride: Local anesthetic used in the block solution (0.25%, 15 mL per side).
  • Dexamethasone (Drug), also known as Dexamethasone Sodium Phosphate: Adjuvant added to the block solution (8 mg per side) to prolong analgesia.
  • Magnesium Sulphate (Drug), also known as Magnesium Sulfate: Adjuvant added to the block solution (300 mg of 10% per side) to prolong analgesia.
  • Modified Thoracolumbar Interfascial Plane Block (Procedure), also known as mTLIP Block: Ultrasound-guided injection between the longissimus and iliocostalis muscles at the L3 level.
  • Retrolaminar Block (Procedure), also known as RLB: Ultrasound-guided injection on the posterior surface of the vertebral lamina at the L3 level, deep to the erector spinae muscles.

+Outcome measures

Primary outcomes

  • Total morphine consumption in the first 24 hours postoperatively [24 hours postoperatively]: Cumulative morphine dose (mg) administered as rescue analgesia during the first 24 postoperative hours

Secondary outcomes

  • Pain intensity by Numerical Rating Scale (NRS) [At 2, 4, 8, 12, 18, and 24 hours postoperatively]: Pain intensity assessed using a 10-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable)
  • Time to first rescue analgesia [First 24 hours postoperatively]: Time from local anesthetic injection until the patient first requests additional pain-relieving medication (NRS > 3)
  • Block performance time [During block procedure]: Time required to perform the block procedure
  • Onset of sensory block [Within 20-30 minutes after injection]: Time from local anesthetic injection until loss of sensation in the desired dermatomes
  • Opioid-related side effects [24 hours postoperatively]: Incidence of postoperative nausea and vomiting (PONV) assessed by PONV impact scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), sedation, and respiratory depression
  • Patient satisfaction score [24 hours postoperatively]: Patient satisfaction assessed using a 4-point scale (4 = excellent, 3 = good, 2 = fair, 1 = poor)
  • Incidence of chronic pain [3 to 6 months postoperatively]: 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).
  • Time of ambulation [First 24 hours postoperatively]: Time to first mobilization after surgery

+Eligibility

Sex: All, ages: 21 Years to 65 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

FacilityCityCountryStatus
Zagazig University Hospitals, Anesthesia, Intensive Care and Pain Management DepartmentZagazig, Sharqia ProvinceEgyptRecruiting

+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 26149600

+Investigators