Postoperative PainNCT04757480
Thoracolumbar Interfascial Plane Block Versus Bilateral Erector Spinae Plane Block In Lumbar Laminectomy
A study testing Thoracolumbar Interfascial Plane Block (TLIP) and Bilateral Erector Spinae plane Block (ESB) in people with Postoperative Pain and Lumbar Laminectomy, run by Tanta University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Postoperative Pain, Lumbar Laminectomy, Thoracolumbar Interfascial Plane Block
- What is being tested?
- Thoracolumbar Interfascial Plane Block (TLIP) and Bilateral Erector Spinae plane Block (ESB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 10 Oct 2021
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Body mass index >32
- History of relevant allergy to any of the drugs used in the procedure
- Previous lumbar spine surgery or back surgery with planed spinal fixation
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta University Hospitals
Tanta, ElGharbiaa, 31511
Aliaa M Abdel kader, 01021559948, aliaa.hasanin@gmail.com
00201000629011
About this study
Official title: Ultrasound Guided Thoracolumbar Interfascial Plane Block Versus Bilateral Ultrasound Guided Erector Spinae Plane Block for Post-Operative Pain Management In Lumbar Laminectomy
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
- Conditions
- Postoperative Pain, Lumbar Laminectomy, Thoracolumbar Interfascial Plane Block, Erector Spinae Plane Block, Ultrasound
- Being tested
- Thoracolumbar Interfascial Plane Block (TLIP), Bilateral Erector Spinae plane Block (ESB)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbar Interfascial Plane Block (TLIP)Procedure or surgery
(20ml) (plain bupivacaine 0.25% on each side toward the LG-MF interface.
Bilateral Erector Spinae plane Block (ESB)Procedure or surgery
Will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the eighth thoracic segment (T8).
| Study group | Role | What they receive |
|---|---|---|
| Thoracolumbar Interfascial Plane Block (TLIP) | Experimental | Not described Receives: Procedure: Thoracolumbar Interfascial Plane Block (TLIP) |
| Bilateral Erector Spinae plane Block (ESB) | Experimental | Not described Receives: Procedure: Bilateral Erector Spinae plane Block (ESB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: First 24 hours postoperative
Secondary outcomes (5)
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)
Measured: First 24 hours postoperative
Total rescue analgesics consumption
Measured: First 24 hours postoperative
The time to first analgesic
Measured: First 24 hours postoperative
24-h morphine consumption
Measured: First 24 hours postoperative
Side effects associated with morphine
Measured: First 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion10 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Mohammad Abdel Reeheem Abdel kader, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757480
- Sponsor's protocol ID
- 33444/10/19
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available with reasonalble consent
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Thoracolumbar Interfascial Plane Block Versus Bilateral Ultrasound Guided Erector Spinae Plane Block for Post-Operative Pain Management In Lumbar Laminectomy
- ClinicalTrials.gov ID
- NCT04757480
- Acronym / sponsor ID
- 33444/10/19
- Conditions
- Postoperative Pain, Lumbar Laminectomy, Thoracolumbar Interfascial Plane Block, Erector Spinae Plane Block, Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 10 Oct 2021 (estimated)
- First posted
- 17 Feb 2021 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracolumbar Interfascial Plane Block (TLIP) | Experimental | Procedure: Thoracolumbar Interfascial Plane Block (TLIP) |
| Bilateral Erector Spinae plane Block (ESB) | Experimental | Procedure: Bilateral Erector Spinae plane Block (ESB) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Body mass index >32
- History of relevant allergy to any of the drugs used in the procedure
- Previous lumbar spine surgery or back surgery with planed spinal fixation
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 |
|---|---|---|
| Thoracolumbar Interfascial Plane Block (TLIP)(20ml) (plain bupivacaine 0.25% on each side toward the LG-MF interface. | Procedure or surgery | Thoracolumbar Interfascial Plane Block (TLIP) |
| Bilateral 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). | Procedure or surgery | Bilateral Erector Spinae plane Block (ESB) |
Primary outcome
Degree of pain by visual Analog Scale (VAS) score at rest
Time frame: First 24 hours postoperative
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)
5 secondary outcomes
Degree of pain by visual Analog Scale (VAS) score at movement
Time frame: First 24 hours postoperative
Total rescue analgesics consumption
Time frame: First 24 hours postoperative
The time to first analgesic
Time frame: First 24 hours postoperative
24-h morphine consumption
Time frame: First 24 hours postoperative
Side effects associated with morphine
Time frame: First 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: Yes. The data will be available with reasonalble consent
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracolumbar Interfascial Plane Block (TLIP) and Bilateral Erector Spinae plane Block (ESB) in people with Postoperative Pain and Lumbar Laminectomy, 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain by visual Analog Scale (VAS) score at rest (time frame: First 24 hours 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 17 Feb 2021.