NCT07394816

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

January 31, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

January 31, 2026

Last Update Submit

April 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative pulmonary complications (PPCs)

    Postoperative pulmonary complications will be defined and recorded according to the European Perioperative Clinical Outcome (EPCO) criteria.

    Within the first 7 postoperative days

Study Arms (2)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients aged 65 years and older who are scheduled to undergo elective major abdominal surgery under general anesthesia. Eligible participants will be managed in a tertiary care hospital and will be allocated to either a fascial plane block group or a control group receiving standard perioperative analgesia. The study aims to evaluate postoperative outcomes in an elderly surgical population with comparable baseline characteristics.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital

Yenimahalle, Ankara, 06370, Turkey (Türkiye)

RECRUITING

Study Officials

  • arif timuroglu

    Dr. Abdurrahman yurtaslan Ankara Oncology Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology and Intensive Care

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 6, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional policies and concerns regarding patient confidentiality and data protection.

Locations