Clinical Outcomes of Analgesia Methods in Patients With Hip Fracture

NCT ID: NCT03670290

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-15
• Study Completion Date: 2019-10-15

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.

Detailed Description

Hip fracture is one of the most serious consequences of falls in the elderly, with a mortality of 10% at one month and 30% at one year. Factors of associated with increased morbidity and mortality have been researched to prevent complications.

Pain has been associated with delirium and depression in hip fracture patients. Besides, narcotic drugs are also associated with some side effects such as delirium, postoperative nausea and vomiting (PONV ), cardiovascular and respiratory depression. These clinical problems are especially important in the elderly population.

Fascia iliaca compartment block (FICB) is one of the methods applied for postoperative analgesia, which is applied under the inguinal ligament and distributes between the femoral nerve and lateral femoral cutaneous nerve block by volumetric effect. Recently, studies have been published on hip fracture patients using pop up technique in emergency services. Although many studies have shown that FICB is effective in perioperative analgesia, the effects of this method on complications and mortality rate have not yet been investigated.

The primary objective is to compare morphine consumption and VAS scores in patients with hip fracture who treated with epidural catheter, fascia iliaca compartment catheter or patient controlled analgesia.

The secondary objective is to determine complications. The investigators hypothesize that FICB catheter will provide good pain control same as epidural catheter, and will decrease complications such as delirium and pain with less mortality rate.

Patients with pain in the hip fracture, will be evaluated after admission to the hospital and analgesic treatment will be applied to patients with Visual Analog Pain Scale (VAS) score 3 and above.

Patients will be divided into three groups; Group I will include patients with treated FICB catheter, Group II will include patients with treated patient controlled analgesia, Group III will include patients with treated epidural catheter,

Catheters will be placed with US visualization in Group I. A hyperechoic needle will be used (18 G 80 mm) for inserting catheter in Group I and III.

Group I will receive 30 ml of Bupivacaine 0.25% solution through the fascia iliaca compartment catheter.

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.

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

Conditions

Hip Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Fascia iliaca compartment catheter

Intervention Type: 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 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.

patient controlled analgesia

Intervention Type: PROCEDURE

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

Group 3

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

epidural catheter

Intervention Type: 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.

Interventions

Fascia iliaca compartment catheter

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.

Intervention Type: PROCEDURE

epidural catheter

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.

Intervention Type: PROCEDURE

patient controlled analgesia

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Azizoğlu

Assistant Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa Azizoglu

Role: STUDY_DIRECTOR

Mersin University, Anesthesia and Reanimation Department

Locations

Mustafa AZİZOĞLU

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MEUANEST001

Identifier Type: -

Identifier Source: org_study_id