Post Operative PainNCT05705739
Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block
A study testing retrolaminar block and ESPB in people with Post Operative Pain and Analgesia, run by Minia University at 1 site in Egypt.
Trial summary
Retrolaminar block (RLB) and erector spinae plane block (ESPB) are alternative approaches to paravertebral block (PVB) and are advantageous in that they are easier and safer techniques compared with the traditional PVB. These blocks are considered to be compartment blocks or interfascial plane blocks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain, Analgesia
- What is being tested?
- retrolaminar block and ESPB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2023to 1 Aug 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age18-60.
- Both genders.
- hepatobiliary surgery.
- ASA I-III.
Who cannot join
- Drug allergy.
- Morbid obesity (BMI >40 kg/m2).
- Psychiatric disorder.
- Opiod dependence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block for Postoperative Pain in Patients Undergoing Hepatobiliary Surgery
Retrolaminar block (RLB) and erector spinae plane block (ESPB) are alternative approaches to paravertebral block (PVB) and are advantageous in that they are easier and safer techniques compared with the traditional PVB. These blocks are considered to be compartment blocks or interfascial 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.
the study aim to evaluate and compare the analgesic efficacy of retrolaminar plane block and erector spinae plane block.
- Conditions
- Post Operative Pain, Analgesia
- Being tested
- retrolaminar block, ESPB
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrolaminar blockProcedure or surgery
curved probe will be placed 1-1.5 cm lateral to the target spinous process after identification of the lamina, the needle will be advanced caudally until it contacts the lamina
ESPBProcedure or surgery
curved probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle.
| Study group | Role | What they receive |
|---|---|---|
| Retrolaminar plane block | Experimental | Not described Receives: Procedure: retrolaminar block |
| ESPB | Experimental | Not described Receives: Procedure: ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain scale
score from 0-10 (0 mean no pain and 10 the worst pain )
Measured: 24 hour
Secondary outcomes (2)
Time of first post operative analgesic request.
time to demand rescue analgesia
Measured: 24 hour
Total analgesic consumption
total fentanyl consumption during the first day postoperative
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start10 Feb 2023
- Primary completion1 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Minia 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mokhtar Elshorbagy Hetta, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705739
- Sponsor's protocol ID
- 544/2022
- Status last verified
- Oct 2023
- First submitted
- 20 Jan 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block for Postoperative Pain in Patients Undergoing Hepatobiliary Surgery
- ClinicalTrials.gov ID
- NCT05705739
- Acronym / sponsor ID
- 544/2022
- Conditions
- Post Operative Pain, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 31 Jan 2023 (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.
Retrolaminar block (RLB) and erector spinae plane block (ESPB) are alternative approaches to paravertebral block (PVB) and are advantageous in that they are easier and safer techniques compared with the traditional PVB. These blocks are considered to be compartment blocks or interfascial 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.
the study aim to evaluate and compare the analgesic efficacy of retrolaminar plane block and erector spinae plane block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrolaminar plane block | Experimental | Procedure: retrolaminar block |
| ESPB | Experimental | Procedure: ESPB |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age18-60.
- Both genders.
- hepatobiliary surgery.
- ASA I-III.
Key exclusion criteria (4 listed)
- Drug allergy.
- Morbid obesity (BMI >40 kg/m2).
- Psychiatric disorder.
- Opiod dependence.
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 blockcurved probe will be placed 1-1.5 cm lateral to the target spinous process after identification of the lamina, the needle will be advanced caudally until it contacts the lamina | Procedure or surgery | Retrolaminar plane block |
| ESPBcurved probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. | Procedure or surgery | ESPB |
Primary outcome
Visual analogue pain scale
Time frame: 24 hour
score from 0-10 (0 mean no pain and 10 the worst pain )
2 secondary outcomes
Time of first post operative analgesic request.
Time frame: 24 hour
Total analgesic consumption
Time frame: 24 hour
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 13 Oct 2023.
- Individual participant dataSharing planned: No
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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 ESPB in people with Post Operative Pain and Analgesia, run by Minia 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 4 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 13 Oct 2023. 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?
Visual analogue pain scale (time frame: 24 hour). 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 13 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.