Bilateral Erector Spinae Plane BlockNCT07602452
Bilateral Erector Spinae Plane Block Versus Bilateral Oblique Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia in Colorectal Surgery
A study testing Erector Spinae Plane Block and Oblique Subcostal Transversus Abdominis Plane Block in people with Bilateral Erector Spinae Plane Block and Bilateral Oblique Subcostal Transversus Abdominis Plane Block, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the ultrasound-guided bilateral erector spinae plane block (ESPB) and oblique subcostal transverse abdominal plane block (OSTAPB) for postoperative analgesia in colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bilateral Erector Spinae Plane Block, Bilateral Oblique Subcostal Transversus Abdominis Plane Block, Postoperative Analgesia
- What is being tested?
- Erector Spinae Plane Block and Oblique Subcostal Transversus Abdominis Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2026to 1 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Scheduled for open colorectal surgery under general anesthesia.
Who cannot join
- History of opioid abuse.
- Chronic opioid consumption.
- Body mass index (BMI) ≥ 35 kg/m2.
- Severe cardiac insufficiency, defined as New York Heart Association (NYHA) class III or IV heart failure.
- Renal failure, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
- Hepatic encephalopathy.
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- Having a skin infection at or near the puncture site.
- Coagulopathy, defined as platelet count < 100,000/mm³, INR > 1.5, or use of anticoagulant therapy that could not be withheld.
- Allergy to drugs used in the study.
- History of previous or recurrent laparoscopic cholecystectomy procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Mohammed M Alarousy, MSc, 00201149404478, mohammedalarousy0@gmail.com
Dina Z Khalaf, MD
About this study
Official title: Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Oblique Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia in Colorectal Surgery: A Prospective Randomized Study.
This study aims to compare the ultrasound-guided bilateral erector spinae plane block (ESPB) and oblique subcostal transverse abdominal plane block (OSTAPB) for postoperative analgesia in colorectal surgery.
Read the detailed description
Colorectal surgery remains the therapeutic cornerstone for the management of a wide variety of gastrointestinal disorders encompassing malignancies and inflammatory conditions.
Oblique subcostal transverse abdominal plane block (OSTAPB) is a regional block technique that involves injecting local anesthetics between the transverse abdominal muscle plane and the internal oblique abdominal muscle plane.
Ultrasound-guided erector spinae plane block (ESPB) is a novel technique that specifically targets the ventral rami, dorsal rami, and rami communicantes of the spinal nerves. Local anesthetic agents were observed to extend cranially and caudally over numerous dermatomal levels following injection.
- Conditions
- Bilateral Erector Spinae Plane Block, Bilateral Oblique Subcostal Transversus Abdominis Plane Block, Postoperative Analgesia, Colorectal Surgery
- Being tested
- Erector Spinae Plane Block, Oblique Subcostal Transversus Abdominis Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
Patients will receive ultrasound-guided erector spinae plane block.
Oblique Subcostal Transversus Abdominis Plane BlockOther
Patients will receive ultrasound-guided oblique subcostal transversus abdominis plane block.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients will receive ultrasound-guided erector spinae plane block. Receives: Other: Erector Spinae Plane Block |
| Group II | Experimental | Patients will receive ultrasound-guided oblique subcostal transversus abdominis plane block. Receives: Other: Oblique Subcostal Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 2, 4, 6, 12, and 24 h postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (8)
Time to the first rescue analgesia
Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of morphine administrated.
Measured: 24 hours postoperatively
Intraoperative fentanyl consumption
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Measured: Intraoperatively
Total morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus (maximum dose of 0.5 mg/kg/24hours) if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.
Measured: 24 hours postoperatively
Mean arterial pressure
Mean arterial pressure will be recorded at:
- T0: Baseline reading preoperatively (in the preoperative holding area).
- T1: Immediately before intubation.
- T2: 15 minutes after intubation.
- T3: 30 minutes after intubation.
- T4: 45 minutes after intubation.
- T5: 60 minutes after intubation.
- T6: At the end of surgery.
Measured: Till end of surgery (Up to 2 hours)
Heart rate
Heart rate will be recorded at:
- T0: Baseline reading preoperatively (in the preoperative holding area).
- T1: Immediately before intubation.
- T2: 15 minutes after intubation.
- T3: 30 minutes after intubation.
- T4: 45 minutes after intubation.
- T5: 60 minutes after intubation.
- T6: At the end of surgery.
Measured: Till end of surgery (Up to 2 hours)
Degree of 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
Quality of Recovery
Quality of Recovery (QOR- 15) scale will be recorded at 24 hours after surgery. Each item on the QoR-15 scale is scored from 0 (unfavourable) to 10 (favourable), resulting in an aggregate score from 0 (no recovery) to 150 (total recovery).
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.
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 posted22 May 2026
- Study start21 May 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Mahmoud Mohammed Alarousy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602452
- Sponsor's protocol ID
- MD-316-2026
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Oblique Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia in Colorectal Surgery: A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT07602452
- Acronym / sponsor ID
- MD-316-2026
- Conditions
- Bilateral Erector Spinae Plane Block, Bilateral Oblique Subcostal Transversus Abdominis Plane Block, Postoperative Analgesia, Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 May 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 study aims to compare the ultrasound-guided bilateral erector spinae plane block (ESPB) and oblique subcostal transverse abdominal plane block (OSTAPB) for postoperative analgesia in colorectal surgery.
Detailed description
Colorectal surgery remains the therapeutic cornerstone for the management of a wide variety of gastrointestinal disorders encompassing malignancies and inflammatory conditions.
Oblique subcostal transverse abdominal plane block (OSTAPB) is a regional block technique that involves injecting local anesthetics between the transverse abdominal muscle plane and the internal oblique abdominal muscle plane.
Ultrasound-guided erector spinae plane block (ESPB) is a novel technique that specifically targets the ventral rami, dorsal rami, and rami communicantes of the spinal nerves. Local anesthetic agents were observed to extend cranially and caudally over numerous dermatomal levels following injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Erector Spinae Plane BlockPatients will receive ultrasound-guided erector spinae plane block. |
| Group II | Experimental | Other: Oblique Subcostal Transversus Abdominis Plane BlockPatients will receive ultrasound-guided oblique subcostal transversus abdominis plane block. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 75 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Scheduled for open colorectal surgery under general anesthesia.
Key exclusion criteria (10 listed)
- History of opioid abuse.
- Chronic opioid consumption.
- Body mass index (BMI) ≥ 35 kg/m2.
- Severe cardiac insufficiency, defined as New York Heart Association (NYHA) class III or IV heart failure.
- Renal failure, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
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 ultrasound-guided erector spinae plane block. | Other | Group I |
| Oblique Subcostal Transversus Abdominis Plane BlockPatients will receive ultrasound-guided oblique subcostal transversus abdominis plane block. | Other | Group II |
Primary outcome
Degree of pain
Time frame: 24 hours postoperatively
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 2, 4, 6, 12, and 24 h postoperatively.
8 secondary outcomes
Time to the first rescue analgesia
Time frame: 24 hours postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Total morphine consumption
Time frame: 24 hours postoperatively
Mean arterial pressure
Time frame: Till end of surgery (Up to 2 hours)
Heart rate
Time frame: Till end of surgery (Up to 2 hours)
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Quality of Recovery
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 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 22 May 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.
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 Oblique Subcostal Transversus Abdominis Plane Block in people with Bilateral Erector Spinae Plane Block and Bilateral Oblique Subcostal Transversus Abdominis Plane Block, run by Cairo 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 May 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?
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 Mohammed M Alarousy, MSc (00201149404478, mohammedalarousy0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (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 22 May 2026.