- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06925789
Influence of Standardized Perioperative Anesthetic, Analgesic Care on Outcome of Patients Undergoing Hip Fracture Surgeries
September 18, 2025 updated by: Shubha Srinivasareddy, Milton S. Hershey Medical Center
Influence of Standardized Peri-operative Anesthetic and Analgesic Care on the Outcome of Patients Undergoing Hip Fracture Surgeries
The purpose of this voluntary research study is to clarify whether or not a single injection nerve block done before surgery and after surgery nerve block catheter can effectively enhance recovery in elderly hip fracture patients in terms of reduced delirium, reduced length of stay and improved surgical and anesthesia outcomes.
Delirium is a serious change in mental abilities.
It results in confused thinking and a lack of awareness of someone's surroundings.
The disorder usually comes on fast - within hours or a few days.
Prolonged hospital stay is one of the risk factors for onset of delirium.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Undergoing anesthesia for hip fracture surgery.
- Patients with fracture neck of femur fractures.
- Geriatric patients. (65 years and older)
Exclusion Criteria:
- Non-fracture hip patients
- non-geriatric patients. (Below 65 years old)
- Patients not able to consent themselves
- Non- English-speaking patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Local anesthesia to treat hip fracture in geriatric patients
|
The nerve block is performed when the patients are admitted to the hospital with diagnosed hip fractures.
And another nerve block with catheter is performed for post-operative pain control in geriatric population with 0.25% Ropivacaine 30mls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Control
Time Frame: up to 48 hours post hospital admission.
|
Pain control is determined by the Likert pain scale, where 0 is no pain and 10 as severe pain
|
up to 48 hours post hospital admission.
|
|
Opioid Use
Time Frame: up to 48 hours post hospital admission.
|
Identification of opioid use via the EMR, Opioids usage is measured at as number of morphine equivalents during the hospital admission.
|
up to 48 hours post hospital admission.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delirium score
Time Frame: up to 48 hours post hospital admission.
|
Delirium score is calculated using the FLACC score, where FLACC score of 0 is relaxed and comfortable and FLACC score of 7-10 is severe delirium.
|
up to 48 hours post hospital admission.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shubha Srinivasareddy, MD, Penn State Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
April 7, 2025
First Submitted That Met QC Criteria
April 7, 2025
First Posted (Actual)
April 13, 2025
Study Record Updates
Last Update Posted (Estimated)
September 23, 2025
Last Update Submitted That Met QC Criteria
September 18, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25751
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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