- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07602452
Bilateral Erector Spinae Plane Block Versus Bilateral Oblique Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia in Colorectal Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammed M Alarousy, MSc
- Phone Number: 00201149404478
- Email: mohammedalarousy0@gmail.com
Study Locations
-
-
-
Cairo, Egypt, 12613
- Recruiting
- Cairo University
-
Contact:
- Mohammed M Alarousy, MSc
- Phone Number: 00201149404478
- Email: mohammedalarousy0@gmail.com
-
Sub-Investigator:
- Dina Z Khalaf, MD
-
Sub-Investigator:
- Tamer K Khair, MD
-
Sub-Investigator:
- Shady R Mikhail, MD
-
Sub-Investigator:
- Michael W Halim, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I
Patients will receive ultrasound-guided erector spinae plane block.
|
Patients will receive ultrasound-guided erector spinae plane block.
|
|
Experimental: Group II
Patients will receive ultrasound-guided oblique subcostal transversus abdominis plane block.
|
Patients will receive ultrasound-guided oblique subcostal transversus abdominis plane block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative fentanyl consumption
Time Frame: Intraoperatively
|
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).
|
Intraoperatively
|
|
Degree of patient satisfaction
Time Frame: 24 hours postoperatively
|
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).
|
24 hours postoperatively
|
|
Incidence of adverse events
Time Frame: 24 hours postoperatively
|
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.
|
24 hours postoperatively
|
|
Time to the first rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of morphine administrated.
|
24 hours postoperatively
|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
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.
|
24 hours postoperatively
|
|
Mean arterial pressure
Time Frame: Till end of surgery (Up to 2 hours)
|
Mean arterial pressure will be recorded at:
|
Till end of surgery (Up to 2 hours)
|
|
Heart rate
Time Frame: Till end of surgery (Up to 2 hours)
|
Heart rate will be recorded at:
|
Till end of surgery (Up to 2 hours)
|
|
Quality of Recovery
Time Frame: 24 hours postoperatively
|
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).
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MD-316-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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