- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394816
Can Ultrasound-Guided Fascial Plane Blocks Reduce Postoperative Pulmonary Complications After Major Abdominal Surgery? (FPB-PPC)
The Effect of Ultrasound-Guided Fascial Plane Blocks on Postoperative Pulmonary Complications in Patients Undergoing Major Abdominal Surgery: A Prospective Observational Study
This prospective observational study aims to evaluate whether the use of ultrasound-guided fascial plane blocks is associated with a lower incidence of postoperative pulmonary complications in adult patients undergoing elective major abdominal surgery under general anesthesia.
Patients will be observed in two groups based on routine clinical practice: those who receive an ultrasound-guided fascial plane block for postoperative analgesia and those managed with other standard analgesic methods. The choice of analgesic technique will be determined by the responsible anesthesia team and not influenced by the study.
Postoperative pulmonary complications occurring within the first 7 days after surgery will be recorded using reopening the European Perioperative Clinical Outcome (EPCO) criteria. Secondary outcomes will include unplanned intensive care unit admission, length of hospital stay, and 30-day mortality. No additional procedures or interventions will be performed for research purposes.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: arif timuroglu
- Phone Number: +905072601980
- Email: ariftimuroglu@yahoo.com
Study Locations
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Ankara
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Yenimahalle, Ankara, Turkey (Türkiye), 06370
- Recruiting
- Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital
-
Contact:
- arif timuroglu
- Phone Number: +905072601980
- Email: ariftimuroglu@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 65 years or older
- Scheduled for elective major abdominal surgery (e.g., colorectal, hepatobiliary, pancreatic, or gastric surgery)
- ASA physical status II-III
- Ability to provide written informed consent
- Planned use of general anesthesia with or without adjunct regional techniques
Exclusion Criteria:
- Refusal or inability to provide informed consent
- Known allergy or contraindication to local anesthetics
- Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia
- Infection at the site of planned block
- Pre-existing chronic opioid use or chronic pain syndrome
- Severe hepatic, renal, or cardiac failure (e.g., Child-Pugh C, end-stage renal disease, EF <30%)
- Cognitive impairment or severe dementia preventing adequate pain assessment
- Emergency surgery
- Body mass index (BMI > 40 kg/m²)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Fascial Plane Block Group
Patients undergoing elective major abdominal surgery who receive an ultrasound-guided fascial plane block at the end of surgery as part of routine clinical practice for postoperative analgesia.
The decision to perform the block is made by the responsible anesthesia team and is not influenced by the study protocol.
|
|
Control Group
Patients undergoing elective major abdominal surgery who do not receive an ultrasound-guided fascial plane block and are managed with other routine postoperative analgesic methods, including epidural analgesia, intravenous patient-controlled analgesia, or oral analgesics, according to standard clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative pulmonary complications (PPCs)
Time Frame: Within the first 7 postoperative days
|
Postoperative pulmonary complications will be defined and recorded according to the European Perioperative Clinical Outcome (EPCO) criteria.
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Within the first 7 postoperative days
|
Collaborators and Investigators
Investigators
- Principal Investigator: arif timuroglu, Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital
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
- 2025-12/186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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