Postop Pain Control in Hip Fracture Surgery: Fascia Iliaca Compartment Block Versus Fracture Block

NCT04335461 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 2019-10737
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to investigate the effect of intraoperative FICB and intrafragmentary fracture blockade on postoperative pain and opiate consumption using a randomized controlled trial study design. There will be three treatment groups: (1) fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine (2) intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine and (3) placebo group, with no intervention.

Conditions

Hip Fractures; Analgesia; Opioid Use; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Pain visual analog scores

  The pain visual analog scale will be used to record pain scores from 0 (no pain) to 10 (worst pain imaginable).

  24 hours

Secondary Outcomes (1)

• Opioid usage

  24 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo group, with no regional nerve blockade administered.

Procedure: Cephalomedullary nailing of extracapsular hip fracture; Device: cephalomedullary nail

Fracture block

EXPERIMENTAL

Patients will have an intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine

Procedure: Cephalomedullary nailing of extracapsular hip fracture; Device: cephalomedullary nail; Drug: Regional Anesthetics

Fascia iliaca block

EXPERIMENTAL

Fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine

Procedure: Cephalomedullary nailing of extracapsular hip fracture; Device: cephalomedullary nail; Drug: Regional Anesthetics

Interventions

Cephalomedullary nailing of extracapsular hip fracture PROCEDURE

All patients will undergo cephalomedullary nailing of their extracapsular hip fractures. Both short and long nails will be used based on fracture morphology.

Fascia iliaca block; Fracture block; Placebo

cephalomedullary nail DEVICE

Implants to be used will be variable, but include Stryker Gamma, Synthes Trochanteric Fixation Nail, Smith and Nephew Intertan.

Fascia iliaca block; Fracture block; Placebo

Regional Anesthetics DRUG

Marcaine 0.25% will be administered for the two experimental arms, as described in above protocol.

Also known as: Local anesthetics

Fascia iliaca block; Fracture block

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 60 years or older
• low energy mechanism (i.e. mechanical or syncopal fall from ground level)
• extracapsular location as defined on AP and lateral radiographs of the hip

You may not qualify if:

• polytrauma patients with multiple injuries, high energy mechanisms (i.e. pedestrian struck, motor vehicle collision, fall from height)
• inability for the patient to consent for themselves
• pathologic fracture types (secondary to tumor or atypical fractures due to bisphosphonate use)
• intolerance or allergies to opioids or local anesthetics

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Jacobi Medical Center: collaborator

Study Sites (1)

Jacobi Medical Center

New York, New York, 10461, United States

Location

Related Publications (17)

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• Malik AT, Quatman CE, Phieffer LS, Ly TV, Khan SN. Incidence, risk factors and clinical impact of postoperative delirium following open reduction and internal fixation (ORIF) for hip fractures: an analysis of 7859 patients from the ACS-NSQIP hip fracture procedure targeted database. Eur J Orthop Surg Traumatol. 2019 Feb;29(2):435-446. doi: 10.1007/s00590-018-2308-6. Epub 2018 Sep 18.

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• Sieber FE, Mears S, Lee H, Gottschalk A. Postoperative opioid consumption and its relationship to cognitive function in older adults with hip fracture. J Am Geriatr Soc. 2011 Dec;59(12):2256-62. doi: 10.1111/j.1532-5415.2011.03729.x. Epub 2011 Nov 7.

  PMID: 22092232 BACKGROUND

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  PMID: 29318091 BACKGROUND

• Swenson JD, Davis JJ, Stream JO, Crim JR, Burks RT, Greis PE. Local anesthetic injection deep to the fascia iliaca at the level of the inguinal ligament: the pattern of distribution and effects on the obturator nerve. J Clin Anesth. 2015 Dec;27(8):652-7. doi: 10.1016/j.jclinane.2015.07.001. Epub 2015 Aug 13.

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• Steenberg J, Moller AM. Systematic review of the effects of fascia iliaca compartment block on hip fracture patients before operation. Br J Anaesth. 2018 Jun;120(6):1368-1380. doi: 10.1016/j.bja.2017.12.042. Epub 2018 Apr 5.

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• Morrison RS, Dickman E, Hwang U, Akhtar S, Ferguson T, Huang J, Jeng CL, Nelson BP, Rosenblatt MA, Silverstein JH, Strayer RJ, Torrillo TM, Todd KH. Regional Nerve Blocks Improve Pain and Functional Outcomes in Hip Fracture: A Randomized Controlled Trial. J Am Geriatr Soc. 2016 Dec;64(12):2433-2439. doi: 10.1111/jgs.14386. Epub 2016 Oct 27.

  PMID: 27787895 BACKGROUND

• Dickman E, Pushkar I, Likourezos A, Todd K, Hwang U, Akhter S, Morrison S. Ultrasound-guided nerve blocks for intracapsular and extracapsular hip fractures. Am J Emerg Med. 2016 Mar;34(3):586-9. doi: 10.1016/j.ajem.2015.12.016. Epub 2015 Dec 14.

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MeSH Terms

Conditions

Hip Fractures; Agnosia; Pain, Postoperative

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Milan Sen

  Jacobi Medical Center; Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will occur at time of enrollment using unmarked envelopes. After consent, patients will be assigned a study ID that will be transcribed on the opaque envelope. The envelope will be unsealed in the operating room at time of surgery to determine the planned intervention, and it's contents will not be made available to the study personnel gathering postoperative pain data. The envelopes and randomization assignments will be kept in a locked, secured location. The only study personnel who will be unblinded are the operating surgeon and residents and physican assistants assisting in the operating room.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 6, 2020
• Study Start: August 5, 2021
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)