Post Operative PainEOINBvsESBNCT06048744
Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy
A study testing external oblique intercostal block and Erector Spine block in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
The patients will be randomly allocated into two equal groups using a computer program. Group A: will receive U S guided external oblique intercostal block after induction. Group B: Patients will receive US guided erector spine block after induction. 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?
- external oblique intercostal block and Erector Spine block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 25 Jan 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
- Eligible patients will be older than 21 years old with American society of anesthesiology ASA physical status I\& II\&III scheduled for elective (Subcostal) Nephrectomy
Who cannot join
- Patients who are:
- Uncooperative.
- Having allergy to any of the study drugs.
- Known abuse of alcohol or medication.
- Having Local infection at the site of injection or systemic infection.
- Pregnancy.
- With coagulation disorders or on anticoagulation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcoastal Nephrectomy: A Randomised Trial
The patients will be randomly allocated into two equal groups using a computer program.
Group A: will receive U S guided external oblique intercostal block after induction.
Group B:
Patients will receive US guided erector spine block after induction.
Read the detailed description
Patients will be premedicated with IV midazolam (0.05 mg/kg). Under standard monitoring including Electrocardiography, Non-Invasive Blood Pressure, and Pulse Oximetry. General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98%. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation
- Conditions
- Post Operative Pain
- Being tested
- external oblique intercostal block, Erector Spine 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.
external oblique intercostal blockProcedure or surgery
U S guided external oblique intercostal block after induction.
Erector Spine blockProcedure or surgery
US guided erector spine block after induction
| Study group | Role | What they receive |
|---|---|---|
| external oblique intercostal block | Active comparator | After induction of general anesthesia, external oblique intercostal blocks will be performed with patients positioned in the supine position with their ipsilateral arm abducted.
A 14-15 MHz linear ultrasound transducer (Sono-Site) was placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib.
30 ml of bupivacaine 0.25% will be administered incrementally. The drug will be injected after a negative aspiration into the plane deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. Receives: Procedure: external oblique intercostal block |
| Erector Spine Block | Active comparator | After induction of general anesthesia, patients will be positioned in the lateral position . A linear ultrasound transducer will be placed on the midline to identify the T8 spinous process. From this position, the ultrasound transducer was moved 2-3 cm laterally to visualize the hyperechoic line of the T8 transverse process with its associated acoustic shadow inferiorly, and the overlying erector spinae muscle superiorly. 30 ml 0.25% bupivacaine will be injected. Receives: Procedure: Erector Spine block |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for first rescue analgesia
hours
Measured: day 0
Secondary outcomes (2)
visual analogue score VAS score
(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) will be recorded 15 min after extubation (as soon as the patient will be alert enough to report pain)
Measured: 24 hours
the number of rescue analgesics
numbers'
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion20 Dec 2023
- Study completion25 Jan 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.
- More trials run by Menoufia 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
- 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
- Responsible party
- Principal investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- AMAL G SAFAN, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048744
- Sponsor's protocol ID
- 9/2023ANET1-2
- Acronym
- EOINBvsESB
- Status last verified
- Jan 2024
- First submitted
- 11 Sep 2023
- Last updated
- 26 Jan 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 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcoastal Nephrectomy: A Randomised Trial
- ClinicalTrials.gov ID
- NCT06048744
- Acronym / sponsor ID
- EOINBvsESB / 9/2023ANET1-2
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 21 Sep 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.
The patients will be randomly allocated into two equal groups using a computer program.
Group A: will receive U S guided external oblique intercostal block after induction.
Group B:
Patients will receive US guided erector spine block after induction.
Detailed description
Patients will be premedicated with IV midazolam (0.05 mg/kg). Under standard monitoring including Electrocardiography, Non-Invasive Blood Pressure, and Pulse Oximetry. General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98%. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation
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 | Procedure: external oblique intercostal blockAfter induction of general anesthesia, external oblique intercostal blocks will be performed with patients positioned in the supine position with their ipsilateral arm abducted. A 14-15 MHz linear ultrasound transducer (Sono-Site) was placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib. 30 ml of bupivacaine 0.25% will be administered incrementally. The drug will be injected after a negative aspiration into the plane deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. |
| Erector Spine Block | Active comparator | Procedure: Erector Spine blockAfter induction of general anesthesia, patients will be positioned in the lateral position . A linear ultrasound transducer will be placed on the midline to identify the T8 spinous process. From this position, the ultrasound transducer was moved 2-3 cm laterally to visualize the hyperechoic line of the T8 transverse process with its associated acoustic shadow inferiorly, and the overlying erector spinae muscle superiorly. 30 ml 0.25% bupivacaine will be injected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients will be older than 21 years old with American society of anesthesiology ASA physical status I\& II\&III scheduled for elective (Subcostal) Nephrectomy
Key exclusion criteria (7 listed)
- Patients who are:
- Uncooperative.
- Having allergy to any of the study drugs.
- Known abuse of alcohol or medication.
- Having 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 |
|---|---|---|
| external oblique intercostal blockU S guided external oblique intercostal block after induction. | Procedure or surgery | external oblique intercostal block |
| Erector Spine blockUS guided erector spine block after induction | Procedure or surgery | Erector Spine Block |
Primary outcome
time for first rescue analgesia
Time frame: day 0
hours
2 secondary outcomes
visual analogue score VAS score
Time frame: 24 hours
the number of rescue analgesics
Time frame: 24hours
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 26 Jan 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.
AMAL G SAFAN, MD principal investigator
Menoufia 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 external oblique intercostal block and Erector Spine 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 26 Jan 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?
time for first rescue analgesia (time frame: day 0). 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 26 Jan 2024.