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Can Ultrasound-Guided Fascial Plane Blocks Reduce Postoperative Pulmonary Complications After Major Abdominal Surgery? (FPB-PPC)

D

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Status

Begins enrollment this month

Conditions

Abdominal Surgeries
Postoperative Pulmonary Complications (PPCs)
Postoperative Pain Management

Study type

Observational

Funder types

Other

Identifiers

NCT07394816
2025-12/186

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

500 participants in 2 patient groups

Fascial Plane Block Group
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

arif timuroglu

Data sourced from clinicaltrials.gov

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