Pre-op Femoral Nerve Block for Hip Fracture

NCT02450045 | Terminated

• 1 other identifier: Pro00044335
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fractures (broken hips) are common in older people, particularly older women with fragile bones, and usually occur with a simple fall from a standing height. In Canada, over 28,000 hip fractures occur every year, and approximately 900 occur in Edmonton. After a hip fracture, up to 50% of those who survive their hip fracture do not recover to the same level of activity that they had before breaking their hip. Managing pain with any broken bone is very important. For patients with hip fracture, their older age and fragile health makes pain management even more challenging. Many patients with a hip fracture have reduced ability to think clearly before the fracture. Some patients who have no difficulty with thinking before their hip fracture will become confused for a brief period after their hip fracture or can develop permanent difficulties with thinking. A hip fracture will usually require an operation, and choosing the right pain medication before and after the operation is important since many pain medications make confusion more likely. Permanent difficulty with thinking is a common reason for poor recovery after hip fracture. Our study will look at use of a nerve block to manage pain before patients have their operation. A nerve block provides local pain relief without requiring patients to take the medication by mouth (oral) or through an intravenous (IV) route. A nerve block before surgery may reduce the amount of oral and IV pain medication needed by the patient both before and after their operation but still provide good pain control with less confusion. This could lead to better recovery and allow more patients to return to living in the community rather than long-term care.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (2)

• Pain at rest

  Visual Analogue Scale and Checklist of Non-verbal Pain Indicators

  up to 5 days post-operative

• Pain upon movement

  Visual Analogue Scale and Checklist of Non-verbal Pain Indicators

  up to 5 days post-operative

Secondary Outcomes (2)

• Cognitive function

  up to 5 days post-operative

• Analgesia consumption

  up to 5 days post-operative

Study Arms (2)

Femoral nerve block

ACTIVE COMPARATOR

Patients will receive a pre-operative continuous femoral nerve block.

Procedure: Continuous femoral nerve block; Drug: 0.5% Ropivacaine/0.125% Bupivacaine local anesthetic mixture

Control

NO INTERVENTION

Patients will receive standard care without a continuous femoral nerve block.

Interventions

Continuous femoral nerve block PROCEDURE

Femoral nerve block

0.5% Ropivacaine/0.125% Bupivacaine local anesthetic mixture DRUG

Femoral nerve block

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Ambulatory pre-fracture
• Sustained a low-energy hip fracture (i.e., fall from standing)
• Mini Mental Status Examination (MMSE) score of 13 (moderate dementia) or greater
• Consent to participate in study

You may not qualify if:

• Failure to obtain consent
• Admitted to hospital more than 30 hours from injury
• Regular use of opiate medications
• Confusion Assessment Method (CAM) test not performed within 6 hours of ward admission
• Known allergy to local anesthetic

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (2)

• Beaupre LA, Johnston DB, Dieleman S, Tsui B. Impact of a preemptive multimodal analgesia plus femoral nerve blockade protocol on rehabilitation, hospital length of stay, and postoperative analgesia after primary total knee arthroplasty: a controlled clinical pilot study. ScientificWorldJournal. 2012;2012:273821. doi: 10.1100/2012/273821. Epub 2012 Apr 30.

  PMID: 22666096 BACKGROUND

• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

  PMID: 33238043 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 21, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CA (1)