CClinicalTrials.gg
Status unknownNCT04757480Updated Feb 17, 2021

Thoracolumbar Interfascial Plane Block Versus Bilateral Erector Spinae Plane Block In Lumbar Laminectomy

An interventional study of Thoracolumbar Interfascial Plane Block (TLIP) and Bilateral Erector Spinae plane Block (ESB) in Postoperative Pain, Lumbar Laminectomy and Thoracolumbar Interfascial Plane Block, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
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Study summary

The aim of this prospective randomized trial is to compare the efficacy ultrasound guided thoracolumbar interfascial plane block versus bilateral ultrasound guided erector spinae plane block for post-operative pain management after lumbar laminectomy

02

Conditions studied

  • Postoperative Pain
  • Lumbar Laminectomy
  • Thoracolumbar Interfascial Plane Block
  • Erector Spinae Plane Block
  • Ultrasound

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In context

Pain, Postoperative

5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's planned enrollment of 70 is close to the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Seventy cases with herniated lumbar disc scheduled for lumbar single-level or multiple-level lumbar discectomy with American Society of Anesthesiologists physical status (ASA) I or II aged between 21 and 60 years of both genders.

Exclusion criteria

Exclusion Criteria:

  1. Body mass index >32
  2. History of relevant allergy to any of the drugs used in the procedure
  3. Previous lumbar spine surgery or back surgery with planed spinal fixation
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Thoracolumbar Interfascial Plane Block (TLIP)

    Procedure: Thoracolumbar Interfascial Plane Block (TLIP)

  • Experimental
    Bilateral Erector Spinae plane Block (ESB)

    Procedure: Bilateral Erector Spinae plane Block (ESB)

Interventions

  • ProcedureThoracolumbar Interfascial Plane Block (TLIP)

    (20ml) (plain bupivacaine 0.25% on each side toward the LG-MF interface.

  • ProcedureBilateral Erector Spinae plane Block (ESB)

    Will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the eighth thoracic segment (T8).

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What researchers measure

Primary outcomes

  1. Degree of pain by visual Analog Scale (VAS) score at rest

    Pain scores will be observed and recorded using the Visual Analog Scale (VAS) both at rest and during movement. The scores will be recorded in the ward at 2, 4, 8, 12, and 24 h. VAS score from 0 to 10 (0: No pain, 10: The worst pain)

    Time frame: First 24 hours postoperative

Secondary outcomes

  1. Degree of pain by visual Analog Scale (VAS) score at movement

    Pain scores will be observed and recorded using the Visual Analog Scale (VAS) both at rest and during movement. The scores will be recorded in the ward at 2, 4, 8, 12, and 24 h VAS score from 0 to 10 (0: No pain, 10: The worst pain)

    Time frame: First 24 hours postoperative

  2. Total rescue analgesics consumption

    Time frame: First 24 hours postoperative

  3. The time to first analgesic

    Time frame: First 24 hours postoperative

  4. 24-h morphine consumption

    Time frame: First 24 hours postoperative

  5. Side effects associated with morphine

    Time frame: First 24 hours postoperative

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Study locations

1 site
  • Tanta University Hospitals
    Tanta, ElGharbiaa 31511, Egypt
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References and documents

Individual participant data

Plan to share: Yes — The data will be available with reasonalble consent

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04757480
Lead sponsor
Tanta University
Responsible party
Aliaa Mohammad Abdel Reeheem Abdel kader (Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University) — Principal investigator
First posted
Feb 17, 2021
Start date
Mar 1, 2021 (estimated)
Primary completion
Sep 30, 2021 (estimated)
Completion
Oct 10, 2021 (estimated)
Last update
Feb 17, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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