Post Operative PainEOINBNCT06514417
External Oblique Intercostal Plane Block for Patients Undergoing Upper Abdominal Surgeries
A study testing US-guided external oblique intercostal block in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
Ithe study will evaluate the analgesic efficacy of external oblique intercostal block for patients undergoing upper abdominal surgeries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- US-guided external oblique intercostal block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2023to 10 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Selected patients will be more than 21 years old with ASA physical status I \& II scheduled for upper abdominal surgeries
Who cannot join
- Uncooperative patients.
- Patients who have allergy to any of the used drugs.
- Patients who are on opioids.
- Known abuse of alcohol or medication.
- Local infection at the site of injection or systemic infection.
- Pregnancy
- Patients with coagulation disorders or on anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound - Guided External Oblique Intercostal Plane Block for Patients Undergoing Upper Abdominal Surgeries: A Randomized Controlled Trial
Ithe study will evaluate the analgesic efficacy of external oblique intercostal block for patients undergoing upper abdominal surgeries
Read the detailed description
Patients will be randomly divided into two equal groups using SPSS. Group A: will receive US-guided external oblique intercostal block after induction Group B: will receive postoperative morphine on patient request. Study design: prospective controlled randomized study.
- Conditions
- Post Operative Pain
- Being tested
- US-guided external oblique intercostal block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided external oblique intercostal blockOther
After induction of general anesthesia, external oblique intercostal block will be performed (8) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz).
the patient will be positioned supine, and a linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib. 20 ml of bupivacaine 0.25% will be injected between the plane of the external oblique and the intercostal muscles. The drug will be injected after a negative aspiration.
The contralateral side block will be performed in a same manner.
| Study group | Role | What they receive |
|---|---|---|
| external oblique intercostal block | Active comparator | receive US-guided external oblique intercostal block after induction Receives: Other: US-guided external oblique intercostal block |
| No block | No intervention | receive postoperative morphine on patient request |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain scale .
postoperative pain that evaluated by visual analogue pain scale(a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)
Measured: 24 hours
Secondary outcomes (1)
total perioperative analgesics requirements
Milligram
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 posted23 Jul 2024
- Study start10 Jul 2023
- Primary completion10 May 2024
- Study completion10 Jun 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Ayman Ahmed Rady, Ahmed Mohamed Helwa
- Responsible party
- Principal investigator, Amal Gouda Elsayed Safan, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514417
- Sponsor's protocol ID
- 7/2023ANET12
- Acronym
- EOINB
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound - Guided External Oblique Intercostal Plane Block for Patients Undergoing Upper Abdominal Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06514417
- Acronym / sponsor ID
- EOINB / 7/2023ANET12
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Ayman Ahmed Rady, Ahmed Mohamed Helwa
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 23 Jul 2024 (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.
Ithe study will evaluate the analgesic efficacy of external oblique intercostal block for patients undergoing upper abdominal surgeries
Detailed description
Patients will be randomly divided into two equal groups using SPSS. Group A: will receive US-guided external oblique intercostal block after induction Group B: will receive postoperative morphine on patient request. Study design: prospective controlled randomized study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| external oblique intercostal block | Active comparator | Other: US-guided external oblique intercostal blockreceive US-guided external oblique intercostal block after induction |
| No block | No intervention | –receive postoperative morphine on patient request |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Selected patients will be more than 21 years old with ASA physical status I \& II scheduled for upper abdominal surgeries
Key exclusion criteria (7 listed)
- Uncooperative patients.
- Patients who have allergy to any of the used drugs.
- Patients who are on opioids.
- Known abuse of alcohol or medication.
- Local infection at the site of injection or systemic infection.
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 |
|---|---|---|
| US-guided external oblique intercostal blockAfter induction of general anesthesia, external oblique intercostal block will be performed (8) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz). the patient will be positioned supine, and a linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib. 20 ml of bupivacaine 0.25% will be injected between the plane of the external oblique and the intercostal muscles. The drug will be injected after a negative aspiration. The contralateral side block will be performed in a same manner. | Other | external oblique intercostal block |
Primary outcome
Visual analogue pain scale .
Time frame: 24 hours
postoperative pain that evaluated by visual analogue pain scale(a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)
1 secondary outcome
total perioperative analgesics requirements
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 24 Jul 2024.
- 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 US-guided external oblique intercostal block in people with Post Operative Pain, run by Menoufia 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 7 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 24 Jul 2024. 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 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 24 Jul 2024.