Post Operative PainNCT05633329
Dual Injection ESPB Versus Single Injection ESPB for Laparotomies
A study testing single level and dual level in people with Post Operative Pain and Regional Block, run by Minia University at 1 site in Egypt.
Trial summary
To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain, Regional Block
- What is being tested?
- single level and dual level
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Dec 2022to 1 Jun 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.
- abdominal surgery.
- ASA I-III.
Who cannot join
- Drug allergy.
- Morbid obesity (BMI >40 kg/m2).
- Psychiatric disorder.
- Opiod dependence.
- patient refuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Efficacy of Ultrasound Guided Single Injection Erector Spinae Plane Block Versus Dual Injection Erector Spinae Plane Block for Postoperative Pain in Patients Undergoing Abdominal Surgery: Randomized Clinical Study
To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies
- Conditions
- Post Operative Pain, Regional Block
- Being tested
- single level, dual level
- Keywords
- ESPB, pain, regional block
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single levelProcedure or surgery
injection of 40 ml bupivacaine 0.25 at T8 (20 ml on each side)
dual levelProcedure or surgery
injection of 40 ml of bupivacaine 0.25 at two level T7 and T9 (10 ml on each level of both side)
| Study group | Role | What they receive |
|---|---|---|
| single ESPB | Experimental | single injection at level T8 Receives: Procedure: single level |
| dual ESB | Experimental | dual injection at level T7 and T9 Receives: Procedure: dual level |
What is being measured
The primary outcome is the main question the study is designed to answer.
first analgesic request
time to request fentanyl
Measured: 24 hours
Secondary outcomes (3)
resting visual analogue pain scale
pain score at rest from 0-10 which 0 mean no pain and 10 the worst pain
Measured: 24 hours
dynamic visual analogue pain scale
pain score at movement (cough) from 0-10 which 0 mean no pain and 10 the worst pain
Measured: 24 hours
analgesic consumption
total fentanyl required first day postoperative
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start7 Dec 2022
- Primary completion1 May 2023
- Study completion1 Jun 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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 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
- Investigators
- hassan m. hetta, lecturer, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633329
- Sponsor's protocol ID
- 474:10/2022
- Status last verified
- Jun 2023
- First submitted
- 4 Nov 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Efficacy of Ultrasound Guided Single Injection Erector Spinae Plane Block Versus Dual Injection Erector Spinae Plane Block for Postoperative Pain in Patients Undergoing Abdominal Surgery: Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05633329
- Acronym / sponsor ID
- 474:10/2022
- Conditions
- Post Operative Pain, Regional Block
- Keywords
- ESPB, pain, regional block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Dec 2022 (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.
To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single ESPB | Experimental | Procedure: single levelsingle injection at level T8 |
| dual ESB | Experimental | Procedure: dual leveldual injection at level T7 and T9 |
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.
- abdominal surgery.
- ASA I-III.
Key exclusion criteria (5 listed)
- Drug allergy.
- Morbid obesity (BMI >40 kg/m2).
- Psychiatric disorder.
- Opiod dependence.
- patient refuse.
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 |
|---|---|---|
| single levelinjection of 40 ml bupivacaine 0.25 at T8 (20 ml on each side) | Procedure or surgery | single ESPB |
| dual levelinjection of 40 ml of bupivacaine 0.25 at two level T7 and T9 (10 ml on each level of both side) | Procedure or surgery | dual ESB |
Primary outcome
first analgesic request
Time frame: 24 hours
time to request fentanyl
3 secondary outcomes
resting visual analogue pain scale
Time frame: 24 hours
dynamic visual analogue pain scale
Time frame: 24 hours
analgesic consumption
Time frame: 24 hours
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 22 Jun 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.
hassan m. hetta, lecturer principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single level and dual level in people with Post Operative Pain and Regional Block, 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 5 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 22 Jun 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?
first analgesic request (time frame: 24 hours). 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 22 Jun 2023.