Provide Post Hepatectomy Pain ControlEOINCT06822309
Bilateral External Oblique Intercostal Plane Block in Post Operative Pain Management in Hepatectomy
A study testing External Oblique Intercostal Plane Block in people with Provide Post Hepatectomy Pain Control, run by Sherif Alaa Embaby.
Trial summary
The majority of cases undergoing hepatectomy suffer from inadequate postoperative analgesia. Therefore, multimodal analgesic techniques are required to relieve pain and discomfort such as intravenous, and epidural analgesia, and peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Provide Post Hepatectomy Pain Control
- What is being tested?
- External Oblique Intercostal Plane Block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 ≥ 18 and ≤ 65 Years.
- Both sexes.
- Patients will be scheduled for hepatectomy surgery.
- Body mass index (BMI) 18.5-30.0 /m 2 .
Who cannot join
- Extension of the surgical incision beyond coverage of T12 dermatome.
- Prolonged time of surgery \> 5 hours.
- Hepatectomy surgery combined with another organ resection.
- Patients with hypersensitivity to local anesthetics.
- History of psychiatric problems.
- Recent history of analgesic drugs including opioid abuse or addiction.
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- Coagulopathy (International normalized ratio [INR] \> 1.4).
- Localized infection at the block site.
- Morbidly obese patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bilateral External Oblique Intercostal Plane Block Versus Patient Controlled Analgesia (PCA) in Post Operative Pain Management in Hepatectomy Surgery.
The majority of cases undergoing hepatectomy suffer from inadequate postoperative analgesia. Therefore, multimodal analgesic techniques are required to relieve pain and discomfort such as intravenous, and epidural analgesia, and peripheral nerve blocks. Although epidural catheters are efficient to provide perioperative analgesia, in this type of surgery patients may be more susceptible to catheter related complications due to the alteration in coagulation parameters. That is why safer alternatives are sought for those patients. The use of patient-controlled analgesia (PCA) for postoperative pain management improves patients' quality of recovery. However, there are many concerns regarding the type of opioids used in PCA such as overdosing, underdosing, and the effect of the hepatectomy on the drug metabolism in those patients. External oblique intercostal plane block (EOI block) is a relatively novel block used in upper abdominal incisions especially subcostal laparotomy to provide intraoperative and postoperative analgesia.
This study aims to compare the efficacy of Bilateral External Oblique Intercostal Plain Block versus PCA in pain management and reduction of opioid use in hepatectomy surgery done by subcostal incision.
- Conditions
- Provide Post Hepatectomy Pain Control
- Being tested
- External Oblique Intercostal Plane Block, Patient controlled analgesia
- Keywords
- External Oblique Intercostal block, subcostal incision, hepatectomy, Patient control analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Oblique Intercostal Plane BlockProcedure or surgery
The block is performed before skin incision by a specialized anesthetist. With the patient positioned in the supine position with their ipsilateral arm abducted, the skin was sterilized, using the high frequency linear probe (M-Turbo HF 38 transducer 13- 6 MHz) of Fujifilm Sonosite ultrasound is placed over the sixth rib medial to the anterior axillary line approximately in midclavicular line in a parasagittal orientation. A 20-guage needle is inserted in a cephalocaudal direction, and the external oblique intercostal plane was hydro dissected with saline. After hydro dissection, the needle is advanced 1 to 2 cm, and 20 mL of 0.25% bupivacaine (Sunny Pharmaceutical) with 4 mg dexamethasone as an additive was administered. The same procedure will be done at the other side (bilateral external oblique intercostal plane block).
Patient controlled analgesiaDevice
Patients in group will receive intravenous patient controlled analgesia device 100 ml (Accuafuser 100 mL, basal rate 4 mL/hr., bolus 0.5 mL/time, and lock time 15 minutes) for postoperative pain management that will contain 30 mg morphine (loading dose0.1mg/kg) will be given by infusion over 10 minutes then accuafuser will be connected),8 mg dexamethasone and 8 mg ondansetron diluted in 100 ml saline.
| Study group | Role | What they receive |
|---|---|---|
| External Oblique Intercostal Plane block | Experimental | Patients in this group will receive External Oblique Intercostal plane block intraoperatively before the surgery. Receives: Procedure: External Oblique Intercostal Plane Block |
| Patient controlled analgesia | Active comparator | Patient will be on patient control analgesia after the surgery. Receives: Device: Patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Rescue morphine consumption in both groups. (Total consumption of morphine rescue shots in milligram in first 2r hours)
Measured: twenty four hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Provide Post Hepatectomy Pain ControlStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherif Alaa Embaby
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherif Alaa Embaby, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822309
- Sponsor's protocol ID
- MS-189-2024
- Acronym
- EOI
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once the study is over and published, all the data will be available.
Publications
Cosarcan SK, Ercelen O. The analgesic contribution of external oblique intercostal block: Case reports of 3 different surgeries and 3 spectacular effects. Medicine (Baltimore). 2022 Sep 9;101(36):e30435. doi: 10.1097/MD.0000000000030435.
PubMed 36086688
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral External Oblique Intercostal Plane Block Versus Patient Controlled Analgesia (PCA) in Post Operative Pain Management in Hepatectomy Surgery.
- ClinicalTrials.gov ID
- NCT06822309
- Acronym / sponsor ID
- EOI / MS-189-2024
- Conditions
- Provide Post Hepatectomy Pain Control
- Keywords
- External Oblique Intercostal block, subcostal incision, hepatectomy, Patient control analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sherif Alaa EmbabyUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 12 Feb 2025 (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 majority of cases undergoing hepatectomy suffer from inadequate postoperative analgesia. Therefore, multimodal analgesic techniques are required to relieve pain and discomfort such as intravenous, and epidural analgesia, and peripheral nerve blocks. Although epidural catheters are efficient to provide perioperative analgesia, in this type of surgery patients may be more susceptible to catheter related complications due to the alteration in coagulation parameters. That is why safer alternatives are sought for those patients. The use of patient-controlled analgesia (PCA) for postoperative pain management improves patients' quality of recovery. However, there are many concerns regarding the type of opioids used in PCA such as overdosing, underdosing, and the effect of the hepatectomy on the drug metabolism in those patients. External oblique intercostal plane block (EOI block) is a relatively novel block used in upper abdominal incisions especially subcostal laparotomy to provide intraoperative and postoperative analgesia.
This study aims to compare the efficacy of Bilateral External Oblique Intercostal Plain Block versus PCA in pain management and reduction of opioid use in hepatectomy surgery done by subcostal incision.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Oblique Intercostal Plane block | Experimental | Procedure: External Oblique Intercostal Plane BlockPatients in this group will receive External Oblique Intercostal plane block intraoperatively before the surgery. |
| Patient controlled analgesia | Active comparator | Device: Patient controlled analgesiaPatient will be on patient control analgesia after the surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 65 Years.
- Both sexes.
- Patients will be scheduled for hepatectomy surgery.
- Body mass index (BMI) 18.5-30.0 /m 2 .
Key exclusion criteria (9 listed)
- Extension of the surgical incision beyond coverage of T12 dermatome.
- Prolonged time of surgery \> 5 hours.
- Hepatectomy surgery combined with another organ resection.
- Patients with hypersensitivity to local anesthetics.
- History of psychiatric problems.
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 Plane BlockThe block is performed before skin incision by a specialized anesthetist. With the patient positioned in the supine position with their ipsilateral arm abducted, the skin was sterilized, using the high frequency linear probe (M-Turbo HF 38 transducer 13- 6 MHz) of Fujifilm Sonosite ultrasound is placed over the sixth rib medial to the anterior axillary line approximately in midclavicular line in a parasagittal orientation. A 20-guage needle is inserted in a cephalocaudal direction, and the external oblique intercostal plane was hydro dissected with saline. After hydro dissection, the needle is advanced 1 to 2 cm, and 20 mL of 0.25% bupivacaine (Sunny Pharmaceutical) with 4 mg dexamethasone as an additive was administered. The same procedure will be done at the other side (bilateral external oblique intercostal plane block). | Procedure or surgery | External Oblique Intercostal Plane block |
| Patient controlled analgesiaPatients in group will receive intravenous patient controlled analgesia device 100 ml (Accuafuser 100 mL, basal rate 4 mL/hr., bolus 0.5 mL/time, and lock time 15 minutes) for postoperative pain management that will contain 30 mg morphine (loading dose0.1mg/kg) will be given by infusion over 10 minutes then accuafuser will be connected),8 mg dexamethasone and 8 mg ondansetron diluted in 100 ml saline. | Device | Patient controlled analgesia |
Primary outcome
• Rescue morphine consumption in both groups. (Total consumption of morphine rescue shots in milligram in first 2r hours)
Time frame: twenty four hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 36086688Cosarcan SK, Ercelen O. The analgesic contribution of external oblique intercostal block: Case reports of 3 different surgeries and 3 spectacular effects. Medicine (Baltimore). 2022 Sep 9;101(36):e30435. doi: 10.1097/MD.0000000000030435.
- Individual participant dataSharing planned: Undecided. Once the study is over and published, all the data will be available.
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.
Questions about this trial
What is this clinical trial studying?
A study testing External Oblique Intercostal Plane Block in people with Provide Post Hepatectomy Pain Control, run by Sherif Alaa Embaby.
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 9 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: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherif A Embaby, Consultant (+447777918923, sherif.embaby@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Rescue morphine consumption in both groups. (Total consumption of morphine rescue shots in milligram in first 2r hours) (time frame: twenty four hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06822309, which also lists 1 linked publication.
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 12 Feb 2025.