Clinical Outcomes of Analgesia Methods in Patients With Hip Fracture

NCT03670290 | Completed

• 1 other identifier: MEUANEST001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine of clinical outcomes of analgesia methods. The primary outcomes are opioid consumption, static and dynamic visual analog scale (VAS) scores. Secondary outcomes are occurrence of side effects.

Conditions

Hip Fractures

Keywords

hip fracture; fascia iliaca compartment catheter; epidural catheter; delirium; postoperative complications

Outcome Measures

Primary Outcomes (2)

• Morphine consumption

  All perioperative morphine consumption will be recoreded every 6 hours.

  From the beginning of treatment to discharge (Totally 5 days)

• Visual analogue score

  Mean visual analogue scores will be compared for 3 groups. VAS score will measured from 0 to 10. Higher values represent worse outcome.

  From admission to second postoperative day. (Totally 5 days)

Secondary Outcomes (1)

• incidence of postoperative complications in 30 day post-surgery.

  From end of surgery to Day 30 after surgery (totally 30 days)

Other Outcomes (1)

• Anticoagulant medication status in the S-FICB group

  First day (15 min)

Study Arms (3)

Group 1

Group I will receive 30 ml of Bupivacaine 0.25% solution through the fascia iliaca compartment catheter. Catheter will be inserted with US.

Procedure: Fascia iliaca compartment catheter

Group 2

Group II will receive, morphine 0.1 mg/ml via patient controlled analgesia pump. every pump will be set 1 mg dose morphine per use and 15 min lockout time.

Procedure: patient controlled analgesia

Group 3

Group III will receive 10 ml of Bupivacaine 0.25% solution through the epidural catheter.

Procedure: epidural catheter

Interventions

Fascia iliaca compartment catheter PROCEDURE

Patient will evaluate and if VAS score \>3, catheter will be inserted and 30 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS\>3 or patient enounce pain.

Group 1

epidural catheter PROCEDURE

Patient will evaluate and if VAS score \>3, catheter will be inserted and 10 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS\>3 or patient enounce pain.

Group 3

patient controlled analgesia PROCEDURE

Patient will evaluate and if VAS score \>3, patient controlled analgesia pump will be set 1mg morphine/15 min lockout.

Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study will be performed from 01/12/2018 to 01/06/2019. It is estimated to each group includes 40 patient.

You may qualify if:

• Patients without communication problems (delirium, hearing loss, language problems etc.)
• Patients who do not use regular analgesic medication for any chronic disease
• Patients without any neurological deficit at the lower extremity
• Patients without renal or hepatic dysfunction
• Patients without bleeding diathesis
• Patients with isolated femur fractures

You may not qualify if:

• Patients with communication problems
• Patients who use regular analgesic medication for any chronic disease
• Patients with neurological deficits in the lower extremity
• Patients with renal or hepatic dysfunction
• Patients with bleeding diathesis
• Patients with multiple trauma

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mustafa AZİZOĞLU

Mersin, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip Fractures; Delirium; Postoperative Complications

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Mustafa Azizoglu

  Mersin University, Anesthesia and Reanimation Department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 13, 2018
• Study Start: December 15, 2018
• Primary Completion: August 31, 2019
• Study Completion: October 15, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After 01/03/2019
• Access Criteria: Sharing access will be depends on requests.

Locations

TU (1)