Fascia Iliaca Compartment Blocks for Pain Control in Hip Fractures

NCT04086914 | Withdrawn Early Phase 1

• 1 other identifier: 00090054
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is comparing the use of a peripheral nerve block and standard opioid pain medications in pain control in hip fractures prior to surgery. A peripheral nerve block is a procedure that injects numbing medicine around a nerve to help decrease the pain, motion, and sensation around the painful site temporarily. The purpose of this study is to evaluate if peripheral nerve blocks are more effective for pain control than just standard opioid pain medication while decreasing the amount of side effects from opioid medication.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (2)

• Mean Baseline Pain score on Visual analogue scale at initial encounter

  pain is measured 1-10, 1 being the lowest and 10 being the highest

  0-60 minutes

• Mean Change from baseline pain score on the visual analogue scale

  pain is measured 1-10, 1 being the lowest and 10 being the highest

  3-8 hours after initial encounter

Study Arms (2)

Non nerve block

NO INTERVENTION

Receives no nerve block

Nerve block

EXPERIMENTAL

Receives nerve block

Procedure: Nerve Block

Interventions

Nerve Block PROCEDURE

This group will receive a nerve block consisting of 20mL of 5mg/mL ropivicanine and 0.1mL of 10mg'mL dexamethasone.

Nerve block

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50 or older, low energy hip fracture, acute hip fracture

You may not qualify if:

• On anticoagulants, hardware present near injection site, preexisting nerve injury.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Related Publications (1)

• 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

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: February 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share