NCT07885358

Brief Summary

Patients requiring surgical jejunostomy or gastrostomy often have advanced malignancy, multiple comorbidities, and limited physiological reserve, which may increase the risks associated with general anesthesia. Ultrasound-guided fascial plane blocks may provide an alternative anesthetic approach in selected high-risk patients. This single-center retrospective observational study aims to evaluate anesthesia management and perioperative outcomes in adult patients who underwent open surgical jejunostomy or gastrostomy using fascial plane blocks as the primary anesthetic strategy between February 2024 and August 2026. The primary outcome is successful completion of surgery without conversion to general anesthesia. Secondary outcomes include supplementary sedative and analgesic requirements, airway interventions, intraoperative adverse events, postoperative rescue analgesia, length of hospital stay, and in-hospital mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

2.6 years

First QC Date

October 11, 2026

Last Update Submit

October 20, 2026

Conditions

Keywords

Regional anesthesiaFascial plane blockRecto-intercostal fascial plane block

Outcome Measures

Primary Outcomes (1)

  • Completion of Surgery Without Conversion to General Anesthesia

    The proportion of patients in whom the planned surgical jejunostomy or gastrostomy was completed using a fascial plane block-based anesthetic strategy, with supplementary sedation or analgesia as clinically indicated, without conversion to general anesthesia. Conversion status was determined from the anesthesia records. The outcome was expressed as the number and percentage of patients, with an exact binomial 95% confidence interval.

    "Perioperative/Periprocedural"

Secondary Outcomes (8)

  • Supplementary Sedative and Analgesic Requirements

    "Perioperative/Periprocedural"

  • New Airway Intervention

    "Perioperative/Periprocedural"

  • Intraoperative Adverse Events

    "Perioperative/Periprocedural"

  • Intraoperative Vasopressor Requirement

    "Perioperative/Periprocedural"

  • Postoperative Rescue Analgesic Requirement

    postoperative 24 hours

  • +3 more secondary outcomes

Study Arms (1)

Fascial Plane Block-Based Anesthesia Group

Adult patients with American Society of Anesthesiologists (ASA) physical status III-IV who underwent open surgical jejunostomy or gastrostomy using ultrasound-guided fascial plane blocks as the primary anesthetic strategy between February 2024 and August 2026. Regional anesthesia techniques included rectus sheath block (RSB), recto-intercostal fascial plane block (RIFPB), serratus-intercostal plane block (SIPB), and thoracoabdominal nerves block through the perichondrial approach (TAPA), administered individually or in combination according to clinical requirements. Intravenous sedation and analgesia were provided when clinically indicated.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with ASA physical status III-IV who underwent open surgical jejunostomy or gastrostomy using ultrasound-guided fascial plane blocks as the planned primary anesthetic strategy at Samsun City Hospital, Türkiye, between February 2024 and August 2026. Eligible patients were identified retrospectively through hospital electronic medical records and anesthesia charts.

You may qualify if:

  • Adults aged 18 years or older.
  • Patients who underwent open surgical jejunostomy or gastrostomy between February 2024 and August 2026.
  • American Society of Anesthesiologists (ASA) physical status III-IV.
  • Use of ultrasound-guided fascial plane blocks as the planned primary anesthetic strategy.
  • Availability of sufficient anesthesia records and perioperative clinical data to assess the primary outcome.

You may not qualify if:

  • Patients younger than 18 years.
  • Patients scheduled to receive general anesthesia from the outset.
  • Patients undergoing endoscopic or radiologically guided jejunostomy or gastrostomy.
  • Insufficient or incomplete medical records preventing assessment of the primary outcome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun City Hospital

Samsun, Samsun, 55080, Turkey (Türkiye)

Location

Study Officials

  • Gamze Ertaş, md

    samsun univercity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology and Reanimation

Study Record Dates

First Submitted

October 11, 2026

First Posted

October 21, 2026

Study Start

February 1, 2024

Primary Completion

September 1, 2026

Study Completion

October 1, 2026

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available due to patient confidentiality and institutional data protection requirements.

Locations