AnalgesiaNCT06519708
Analgesic Efficacy of Erector Spinae Plane Block vs External Oblique Intercostal Plane Block in Subcostal Cancer Surgeries
A study testing Erector Spinae Plane Block and External Oblique Intercostal Plane Block in people with Analgesia and Erector Spinae Plane Block, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims to evaluate the impact of ultrasound-guided erector spinae plane block compared to ultrasound-guided external oblique intercostal plane block regarding management of postoperative acute pain in patients undergoing above Umbilical surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Erector Spinae Plane Block, External Oblique Intercostal Plane Block
- What is being tested?
- Erector Spinae Plane Block and External Oblique Intercostal Plane Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2024to 17 Jan 2026
- 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 (18-65) Years.
- Both sexes.
- Body mass index (BMI): (20-40) kg/m2.
- American Society of Anesthesiology (ASA) physical status II, III.
- Type of surgery; unilateral subcostal incision in hepatectomy and nephrectomy.
Who cannot join
- Patient refusal.
- Subcostal incisions that are crossing the midline or midline incision.
- Age <18 years or >65 years
- BMI <20 kg/m2 and >40 kg/m2
- Known sensitivity or contraindication to drugs used in the study
- Contraindication to regional anesthesia e.g. local infection at the site of introduction, pre-existing peripheral neuropathies, and coagulopathy.
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- Pregnancy.
- Physical status ASA IV
- patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
- patients with a history of drug abuse
- patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
- All patients who are going to have severe intra- or post-operative bleeding or will require postoperative mechanical ventilation are also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Erector Spinae Plane Block vs External Oblique Intercostal Plane Block in Subcostal Cancer Surgeries: A Randomized Controlled Study
This study aims to evaluate the impact of ultrasound-guided erector spinae plane block compared to ultrasound-guided external oblique intercostal plane block regarding management of postoperative acute pain in patients undergoing above Umbilical surgical procedure.
Read the detailed description
Subcostal incisions in cancer surgeries as in hepatectomy and nephrectomy are a cause of severe pain and can lead to significant respiratory impairment. Regional anesthesia of the trunk and abdominal wall is usually centered on epidural analgesia.
Erector spinae plane block (ESPB) is the deposition of local anesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.
The recently described external oblique intercostal plane block (EOIPB) is a simple, effective, and convenient block, particularly in the context of morbid obesity, at which local anesthetic (LA) is deposited in the interfacial plane deep to external oblique muscle at the sixth intercostal space. It provides a blockade of the thoracoabdominal nerves at the level of T6 to T10.
- Conditions
- Analgesia, Erector Spinae Plane Block, External Oblique Intercostal Plane Block, Subcostal Cancer Surgeries
- Being tested
- Erector Spinae Plane Block, External Oblique Intercostal Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockDrug
Patients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.
External Oblique Intercostal Plane BlockDrug
Patients will receive an ultrasound-guided external oblique intercostal plan block Intraoperative with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Patients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia. Receives: Drug: Erector Spinae Plane Block |
| External Oblique Intercostal Plane Block | Experimental | Patients will receive an ultrasound-guided external oblique intercostal plan block Intraoperative with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia. Receives: Drug: External Oblique Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of morphine consumption
Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Total amount of intraoperative fentanyl consumption
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Measured: Intraoperatively
Heart rate
Heart rate will be recorded intraoperatively at 5-minute intervals till the end of surgery and the average of each three successive readings.
Measured: Till the end of surgery
Mean arterial blood pressure
Mean arterial blood pressure will be recorded intraoperatively at 5-minute intervals till the end of surgery and the average of each three successive readings.
Measured: Till the end of surgery
Time of first rescue analgesia
Time of first rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated. Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4.
Measured: 24 hours postoperatively
Complications
Complications related to blocks (local anesthetic systemic toxicity, pneumothorax and arterial puncture) and Morphine related complications (respiratory depression, urine retention or pruritis) will be recorded.
Measured: 24 hours postoperatively
Patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
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 posted25 Jul 2024
- Study start25 Jul 2024
- Primary completion10 Jan 2026
- Study completion17 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Sayed Mohamed Ibrahim, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519708
- Sponsor's protocol ID
- AP2403-201-107
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Erector Spinae Plane Block vs External Oblique Intercostal Plane Block in Subcostal Cancer Surgeries: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06519708
- Acronym / sponsor ID
- AP2403-201-107
- Conditions
- Analgesia, Erector Spinae Plane Block, External Oblique Intercostal Plane Block, Subcostal Cancer Surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 17 Jan 2026 (actual)
- First posted
- 25 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.
This study aims to evaluate the impact of ultrasound-guided erector spinae plane block compared to ultrasound-guided external oblique intercostal plane block regarding management of postoperative acute pain in patients undergoing above Umbilical surgical procedure.
Detailed description
Subcostal incisions in cancer surgeries as in hepatectomy and nephrectomy are a cause of severe pain and can lead to significant respiratory impairment. Regional anesthesia of the trunk and abdominal wall is usually centered on epidural analgesia.
Erector spinae plane block (ESPB) is the deposition of local anesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.
The recently described external oblique intercostal plane block (EOIPB) is a simple, effective, and convenient block, particularly in the context of morbid obesity, at which local anesthetic (LA) is deposited in the interfacial plane deep to external oblique muscle at the sixth intercostal space. It provides a blockade of the thoracoabdominal nerves at the level of T6 to T10.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Drug: Erector Spinae Plane BlockPatients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia. |
| External Oblique Intercostal Plane Block | Experimental | Drug: External Oblique Intercostal Plane BlockPatients will receive an ultrasound-guided external oblique intercostal plan block Intraoperative with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age (18-65) Years.
- Both sexes.
- Body mass index (BMI): (20-40) kg/m2.
- American Society of Anesthesiology (ASA) physical status II, III.
- Type of surgery; unilateral subcostal incision in hepatectomy and nephrectomy.
Key exclusion criteria (12 listed)
- Patient refusal.
- Subcostal incisions that are crossing the midline or midline incision.
- Age <18 years or >65 years
- BMI <20 kg/m2 and >40 kg/m2
- Known sensitivity or contraindication to drugs used in the study
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 |
|---|---|---|
| Erector Spinae Plane BlockPatients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia. | Drug | Erector Spinae Plane Block |
| External Oblique Intercostal Plane BlockPatients will receive an ultrasound-guided external oblique intercostal plan block Intraoperative with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia. | Drug | External Oblique Intercostal Plane Block |
Primary outcome
Total amount of morphine consumption
Time frame: 24 hours postoperatively
Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.
6 secondary outcomes
Total amount of intraoperative fentanyl consumption
Time frame: Intraoperatively
Heart rate
Time frame: Till the end of surgery
Mean arterial blood pressure
Time frame: Till the end of surgery
Time of first rescue analgesia
Time frame: 24 hours postoperatively
Complications
Time frame: 24 hours postoperatively
Patient satisfaction
Time frame: 24 hours postoperatively
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 21 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Erector Spinae Plane Block and External Oblique Intercostal Plane Block in people with Analgesia and Erector Spinae Plane Block, run by National Cancer Institute, Egypt 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 5 inclusion and 12 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 21 Jan 2026. 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?
Total amount of morphine consumption (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 21 Jan 2026.