NCT07081867

Brief Summary

This study compares the postoperative analgesic effectiveness of Sacral Erector Spinae Plane Block (SESPB) and Supra-Inguinal Fascia Iliaca Block (SIFIB) in patients undergoing hip fracture surgery. Both techniques are regional anesthesia methods aiming to reduce postoperative pain and opioid consumption. The study evaluates pain scores, opioid requirements, mobilization times, and hospital discharge times to determine which block provides more effective pain management in different postoperative periods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 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

January 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

July 9, 2025

Last Update Submit

January 22, 2026

Conditions

Keywords

Nerve BlockAnesthesia, RegionalHip FracturesPostoperative PainAnalgesiaVisual Analog ScalePain Measurement

Outcome Measures

Primary Outcomes (4)

  • Postoperative Pain Scores

    Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain scores will be recorded at specific postoperative time points: 1st, 6th, 12th, and 24th hours.

    At 1 hour, 6 hours, 12 hours, and 24 hours postoperatively.

  • Time to First Postoperative Analgesic Requirement

    Time interval from end of surgery to the first request for analgesia.

    Up to 48 hours postoperatively.

  • Total Postoperative Opioid Consumption

    The total amount of opioids required by patients during the postoperative period.

    A week

  • Time to First Mobilization

    The time until patients' first mobilization (walking or standing) after surgery.

    From the end of surgery until first mobilization, typically within 24 to 48 hours postoperatively

Secondary Outcomes (2)

  • Length of Hospital Stay

    Up to 14 days postoperatively.

  • Block-Related Complications

    A week

Study Arms (2)

SIFIB Group

Patients who underwent Supra-Inguinal Fascia Iliaca Block (n=40)

Procedure: Supra-inguinal Fascia Iliaca Block (SIFIB)

SESPB Group

Patients who underwent Sacral Erector Spinae Plane Block (n=37)

Procedure: Sacral Erector Spinae Plane Block (SESPB)

Interventions

Ultrasound-guided injection of 40 mL of 0.25% bupivacaine between the iliacus muscle and fascia iliaca via a supra-inguinal approach, performed preoperatively for postoperative analgesia in patients undergoing hip fracture surgery under spinal anesthesia.

SIFIB Group

Ultrasound-guided injection of 40 mL of 0.25% bupivacaine into the fascial plane deep to the erector spinae muscle at the sacral level (S2), performed preoperatively for postoperative analgesia in patients undergoing hip fracture surgery under spinal anesthesia.

SESPB Group

Eligibility Criteria

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

Patients aged 65 years and older who underwent hip fracture surgery under spinal anesthesia at Prof. Dr. Cemil Taşçıoğlu City Hospital between January and June 2025. Only patients who provided written informed consent and met the inclusion criteria were enrolled.

You may qualify if:

  • Patients aged 65 years and older
  • Patients undergoing surgery for hip fractures under spinal anesthesia
  • Patients who are oriented and cooperative
  • Patients who have signed an informed consent form

You may not qualify if:

  • Patients with contraindications for spinal anesthesia
  • Patients with Alzheimer's disease or dementia, and those who are non-oriented or non-cooperative
  • Patients with major organ failure (such as heart, liver, or kidney failure)
  • Patients who decline to participate in the study
  • Patients classified as American Society of Anesthesiologists (ASA) Physical Status IV or higher
  • Patients with pathological fractures or bone metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Sisli, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip FracturesPain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Beyzanur Aydogdu

    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 23, 2025

Study Start

January 15, 2025

Primary Completion

June 15, 2025

Study Completion

December 1, 2025

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual patient data will not be shared due to patient privacy requirements and ethical board restrictions.

Locations