Postoperative PainNCT05272280
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
A study testing External oblique intercostal (EOI) block and Erector spinae plane block (ESPB) in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- External oblique intercostal (EOI) block and Erector spinae plane block (ESPB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to Mar 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
- patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Patients scheduled for elective laparoscopic cholecystectomy.
Who cannot join
- Allergy to local anaesthetics,
- Infection at the site of injection,
- Coagulopathy,
- Chronic pain syndromes,
- Prolonged opioid medication,
- Patients who received any analgesic 24 h before surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University hospital
Asyut, Assiut, Asyut Governorate, Egypt,
Magdy M Mahdy, Lecturer, 01096502058, magdy.mahdy@aun.edu.eg
About this study
Official title: Ultrasound Guided External Oblique Intercostal (EOI) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia in Laparoscopic Cholecystectomy
To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.
- Conditions
- Postoperative Pain
- Being tested
- External oblique intercostal (EOI) block, Erector spinae plane block (ESPB)
- Keywords
- Cholecystectomy, EOI block, ESP 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 (EOI) blockOther
A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.
Erector spinae plane block (ESPB)Other
A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of Local Anesthetic mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.
| Study group | Role | What they receive |
|---|---|---|
| External oblique intercostal (EOI) block | Active comparator | Not described Receives: Other: External oblique intercostal (EOI) block |
| Erector spinae plane block (ESPB) | Active comparator | Not described Receives: Other: Erector spinae plane block (ESPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nalbuphine consumption in mg equivalent to morphine dose.
mg
Measured: 24 hours postoperatively
Secondary outcomes (6)
Numerical Rating Scale (NRS) at rest and when coughing
11-point scale where 0=no pain and 10=worst pain
Measured: at 1, 2,4 , 8, 16 and 24 hours postoperatively
Analgesic drug consumption other than nalbuphine
in mg
Measured: 24 hours postoperatively
Heart Rate
beats /min
Measured: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Mean Arterial Pressure
mmHg
Measured: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Incidence of Postoperative nausea & vomiting (PONV)
Number of patients developing PONV
Measured: 24 hours postoperatively
Shoulder pain
Number of patients developing Shoulder pain
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 May 2022
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (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 Assiut 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Mohammed Mahdy Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272280
- Sponsor's protocol ID
- ABC-5-DE
- Status last verified
- Jul 2024
- First submitted
- 28 Feb 2022
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided External Oblique Intercostal (EOI) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05272280
- Acronym / sponsor ID
- ABC-5-DE
- Conditions
- Postoperative Pain
- Keywords
- Cholecystectomy, EOI block, ESP block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 9 Mar 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 compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External oblique intercostal (EOI) block | Active comparator | Other: External oblique intercostal (EOI) block |
| Erector spinae plane block (ESPB) | Active comparator | Other: Erector spinae plane block (ESPB) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
- patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Patients scheduled for elective laparoscopic cholecystectomy.
Key exclusion criteria (6 listed)
- Allergy to local anaesthetics,
- Infection at the site of injection,
- Coagulopathy,
- Chronic pain syndromes,
- Prolonged opioid medication,
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 (EOI) blockA high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side. | Other | External oblique intercostal (EOI) block |
| Erector spinae plane block (ESPB)A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of Local Anesthetic mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side. | Other | Erector spinae plane block (ESPB) |
Primary outcome
Nalbuphine consumption in mg equivalent to morphine dose.
Time frame: 24 hours postoperatively
mg
6 secondary outcomes
Numerical Rating Scale (NRS) at rest and when coughing
Time frame: at 1, 2,4 , 8, 16 and 24 hours postoperatively
Analgesic drug consumption other than nalbuphine
Time frame: 24 hours postoperatively
Heart Rate
Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Mean Arterial Pressure
Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Incidence of Postoperative nausea & vomiting (PONV)
Time frame: 24 hours postoperatively
Shoulder pain
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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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 External oblique intercostal (EOI) block and Erector spinae plane block (ESPB) in people with Postoperative Pain, run by Assiut 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 3 inclusion and 6 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 2 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdy M mahdy, MD (0109 650 2058, magdymahdy84@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nalbuphine consumption in mg equivalent to morphine dose. (time frame: 24 hours postoperatively). 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 2 Aug 2024.