CholecystectomyNCT07533279
Erector Spinae Plane Block Versus External Oblique Intercostal Plane Block for Analgesia in Open Cholecystectomy
A study testing Erector Spinae Plane Block and External Oblique Intercostal Plane Block in people with Cholecystectomy and Postoperative Pain, run by Sohag University.
Trial summary
This randomized controlled trial aims to compare the analgesic efficacy of bilateral ultrasound-guided erector spinae plane block (ESPB) versus bilateral external oblique intercostal plane (EOI) block in patients undergoing open cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystectomy, Postoperative Pain, Erector Spinae Plane Block
- What is being tested?
- Erector Spinae Plane Block and External Oblique Intercostal Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to May 2027
- 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
- Adult patients aged 18-65 years.
- Patients scheduled for elective open cholecystectomy.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients who provide informed consent.
Who cannot join
- Patient refusal.
- Known allergy to local anesthetics.
- Coagulopathy or anticoagulant therapy.
- Infection at the site of injection.
- Severe hepatic, renal, or cardiac disease.
- Body mass index (BMI) > 35 kg/m².
- Pregnancy.
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: Efficacy of Bilateral Erector Spinae Plane Block Versus Bilateral External Oblique Intercostal Plane Block for Perioperative Analgesia in Open Cholecystectomy Surgeries: A Randomized Controlled Trial
This randomized controlled trial aims to compare the analgesic efficacy of bilateral ultrasound-guided erector spinae plane block (ESPB) versus bilateral external oblique intercostal plane (EOI) block in patients undergoing open cholecystectomy.
Patients will be randomly allocated into two groups to receive either ESPB or EOI block in addition to standard general anesthesia. The primary outcome is postoperative pain score assessed using the Numerical Rating Scale (NRS) at 2 hours after surgery. Secondary outcomes include intraoperative opioid consumption, postoperative nalbuphine requirements, time to first analgesic request, and hemodynamic changes.
This study seeks to determine the more effective regional anesthesia technique for improving perioperative analgesia in open cholecystectomy.
Read the detailed description
Open cholecystectomy is still indicated in selected patients such as those with complicated gallbladder disease or contraindications to laparoscopy. Effective perioperative pain management is essential to improve patient outcomes and reduce opioid consumption.
Regional anesthesia techniques have gained increasing interest, particularly with the use of ultrasound guidance. The erector spinae plane block (ESPB) is a relatively simple and widely used interfascial block that provides effective analgesia for abdominal surgeries. The external oblique intercostal plane (EOI) block is a newer technique targeting the upper abdominal wall.
In this prospective, randomized, double-blinded clinical trial, adult patients undergoing elective open cholecystectomy will be randomized into two groups. One group will receive bilateral ultrasound-guided ESPB, while the other group will receive bilateral ultrasound-guided EOI block, both performed after induction of general anesthesia and before surgical incision.
All patients will receive standardized general anesthesia. Pain will be assessed using the Numerical Rating Scale (NRS) at multiple time points postoperatively. Rescue analgesia with intravenous nalbuphine will be administered as needed.
The primary outcome is postoperative pain score at 2 hours. Secondary outcomes include intraoperative fentanyl consumption, total nalbuphine consumption over 24 hours, time to first analgesic request, hemodynamic parameters, and any block-related complications.
This study aims to provide evidence regarding the comparative effectiveness of ESPB and EOI block in open cholecystectomy surgeries.
- Being tested
- Erector Spinae Plane Block, External Oblique Intercostal Plane 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.
Erector Spinae Plane BlockProcedure or surgery
Bilateral erector spinae plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.
External Oblique Intercostal Plane BlockProcedure or surgery
Bilateral external oblique intercostal plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block Group | Experimental | Participants in this group will receive bilateral erector spinae plane block using local anesthetic for postoperative analgesia following open cholecystectomy. Receives: Procedure: Erector Spinae Plane Block |
| External Oblique Intercostal Plane Block Group | Experimental | Participants in this group will receive bilateral external oblique intercostal plane block using local anesthetic for postoperative analgesia following open cholecystectomy. Receives: Procedure: External Oblique Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (VAS)
Postoperative pain will be assessed using the Visual Analog Scale (VAS) at rest and during movement.
Measured: Within the first 24 hours postoperatively
Secondary outcomes (3)
Total Opioid Consumption
Total opioid consumption in the first 24 hours after surgery measured in morphine equivalents.
Measured: First 24 hours postoperatively
Time to First Analgesic Request
Time elapsed from the end of surgery to the first request for analgesia.
Measured: Within 24 hours postoperatively
Postoperative Complications
Incidence of postoperative complications including nausea, vomiting, and respiratory complications.
Measured: Within 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 posted16 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive either bilateral erector spinae plane block or bilateral external oblique intercostal plane block.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Salaheldin Ahmed Abdelziz, Sohag University
- Investigators
- Mohamed Mansour, MD, Principal investigator, Professor of Anesthesia, ICU and Pain Management, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533279
- Sponsor's protocol ID
- MD-37-2024
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study investigators do not plan to make individual-level data publicly available. Results will be reported in aggregate form to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bilateral Erector Spinae Plane Block Versus Bilateral External Oblique Intercostal Plane Block for Perioperative Analgesia in Open Cholecystectomy Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07533279
- Acronym / sponsor ID
- MD-37-2024
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Apr 2026 (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 randomized controlled trial aims to compare the analgesic efficacy of bilateral ultrasound-guided erector spinae plane block (ESPB) versus bilateral external oblique intercostal plane (EOI) block in patients undergoing open cholecystectomy.
Patients will be randomly allocated into two groups to receive either ESPB or EOI block in addition to standard general anesthesia. The primary outcome is postoperative pain score assessed using the Numerical Rating Scale (NRS) at 2 hours after surgery. Secondary outcomes include intraoperative opioid consumption, postoperative nalbuphine requirements, time to first analgesic request, and hemodynamic changes.
This study seeks to determine the more effective regional anesthesia technique for improving perioperative analgesia in open cholecystectomy.
Detailed description
Open cholecystectomy is still indicated in selected patients such as those with complicated gallbladder disease or contraindications to laparoscopy. Effective perioperative pain management is essential to improve patient outcomes and reduce opioid consumption.
Regional anesthesia techniques have gained increasing interest, particularly with the use of ultrasound guidance. The erector spinae plane block (ESPB) is a relatively simple and widely used interfascial block that provides effective analgesia for abdominal surgeries. The external oblique intercostal plane (EOI) block is a newer technique targeting the upper abdominal wall.
In this prospective, randomized, double-blinded clinical trial, adult patients undergoing elective open cholecystectomy will be randomized into two groups. One group will receive bilateral ultrasound-guided ESPB, while the other group will receive bilateral ultrasound-guided EOI block, both performed after induction of general anesthesia and before surgical incision.
All patients will receive standardized general anesthesia. Pain will be assessed using the Numerical Rating Scale (NRS) at multiple time points postoperatively. Rescue analgesia with intravenous nalbuphine will be administered as needed.
The primary outcome is postoperative pain score at 2 hours. Secondary outcomes include intraoperative fentanyl consumption, total nalbuphine consumption over 24 hours, time to first analgesic request, hemodynamic parameters, and any block-related complications.
This study aims to provide evidence regarding the comparative effectiveness of ESPB and EOI block in open cholecystectomy surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive either bilateral erector spinae plane block or bilateral external oblique intercostal plane block.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block Group | Experimental | Procedure: Erector Spinae Plane BlockParticipants in this group will receive bilateral erector spinae plane block using local anesthetic for postoperative analgesia following open cholecystectomy. |
| External Oblique Intercostal Plane Block Group | Experimental | Procedure: External Oblique Intercostal Plane BlockParticipants in this group will receive bilateral external oblique intercostal plane block using local anesthetic for postoperative analgesia following open cholecystectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18-65 years.
- Patients scheduled for elective open cholecystectomy.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients who provide informed consent.
Key exclusion criteria (7 listed)
- Patient refusal.
- Known allergy to local anesthetics.
- Coagulopathy or anticoagulant therapy.
- Infection at the site of injection.
- Severe hepatic, renal, or cardiac disease.
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 BlockBilateral erector spinae plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia. | Procedure or surgery | Erector Spinae Plane Block Group |
| External Oblique Intercostal Plane BlockBilateral external oblique intercostal plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia. | Procedure or surgery | External Oblique Intercostal Plane Block Group |
Primary outcome
Postoperative Pain Score (VAS)
Time frame: Within the first 24 hours postoperatively
Postoperative pain will be assessed using the Visual Analog Scale (VAS) at rest and during movement.
3 secondary outcomes
Total Opioid Consumption
Time frame: First 24 hours postoperatively
Time to First Analgesic Request
Time frame: Within 24 hours postoperatively
Postoperative Complications
Time frame: Within 24 hours postoperatively
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 16 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study investigators do not plan to make individual-level data publicly available. Results will be reported in aggregate form to ensure participant confidentiality.
Related trials for Cholecystectomy
Active, not recruitingObservational study
Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study
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Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Active, not recruiting
Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
Acut Postoperative Pain, Erector Spinae Plane Block
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.
Mohamed Mansour, MD principal investigator
Professor of Anesthesia, ICU and Pain Management, Faculty of Medicine, Cairo University
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 Cholecystectomy and Postoperative Pain, run by Sohag University.
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 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: opening soon, as of the sponsor's last update on 16 Apr 2026. 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 Khaled M Hassan mohamed, MD (01153564555, dr.khalid.azab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (VAS) (time frame: Within the first 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 16 Apr 2026.