Clinical Outcomes of Analgesia Methods in Patients With Hip Fracture

Completed

• Conditions: Hip Fractures
• Interventions: Procedure: Fascia iliaca compartment catheter; Procedure: patient controlled analgesia; Procedure: epidural catheter

• Registration Number: NCT03670290
• Lead Sponsor: Mersin University

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.

Study Timeline

• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Study Start: 2018-12-15
• Primary Completion: 2019-08-31
• Study Completion: 2019-10-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Fascia iliaca compartment catheter	Group I will receive 30 ml of Bupivacaine 0.25% solution through the fascia iliaca compartment catheter. Catheter will be inserted with US.
Group 2	patient controlled analgesia	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 3	epidural catheter	Group III will receive 10 ml of Bupivacaine 0.25% solution through the epidural catheter.

Primary Outcome Measures

Name	Time	Method
Morphine consumption	From the beginning of treatment to discharge (Totally 5 days)	All perioperative morphine consumption will be recoreded every 6 hours.
Visual analogue score	From admission to second postoperative day. (Totally 5 days)	Mean visual analogue scores will be compared for 3 groups. VAS score will measured from 0 to 10. Higher values represent worse outcome.

Secondary Outcome Measures

Name	Time	Method
incidence of postoperative complications in 30 day post-surgery.	From end of surgery to Day 30 after surgery (totally 30 days)	Patients will be monitored and every serious complication related with surgery including respiratory failure, hypotension, delirium, thromboembolism, nausea and vomiting will be recorded. These events will be measured as percentage (%)

Trial Locations

Locations (1)

Mustafa AZİZOĞLU; 🇹🇷 Mersin, Turkey