Ultrasound Guided Fascia Iliaca Block for Pain Control After Elective Hip Replacement Surgery

NCT ID: NCT02108847

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

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The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks performed before surgery help to reduce pain after elective total hip replacements.

Detailed Description

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Total hip arthroplasty is associated with moderate to severe pain in the acute postoperative period, which can increase the risk of postoperative complications such as thromboembolism, myocardial ischemia/infarction, pneumonia, poor wound healing, insomnia, and delirium.

Sensory innervation of the hip joint comes from a combination of peripheral nerves, including femoral, obturator, sciatic, superior gluteal, and nerve for the quadratus femoris muscle. Superficial innervation of the skin involved in incision for hip arthroplasty comes from the lateral femoral cutaneous nerve (LFCN).

The fascia iliaca block (FIB) was originally described in 1989 using a landmark technique. The ultrasound guided FIB was introduced in recent years, and has been shown to produce a better quality of block than the landmark technique. It appears to consistently block the femoral and LFCN, while being less successful in achieving consistent obturator blockade.

The FIB is effective for analgesia for hip fracture injuries in the emergency department. Thus far, there has been limited exploration into the potential use of this block as a tool for postoperative analgesia after elective hip arthroplasty. The potential benefits of this regional block, as with other regional techniques, include better analgesia, less opioid use and associated side effects, and an improved overall patient satisfaction with postoperative recovery.

Conditions

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Arthroplasty, Replacement, Hip Fascia Iliaca Block

Keywords

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Arthroplasty, Replacement, Hip Pain, Postoperative Nerve Block Anesthesia, Regional Fascia Iliaca Block Ultrasound Guided

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fascia Iliaca Block - Ropivacaine

Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of 0.2% ropivacaine.

Group Type EXPERIMENTAL

.2% Ropivacaine

Intervention Type DRUG

Fascia Iliaca Block

Intervention Type PROCEDURE

Ultrasound-guided regional anesthesia block to the groin area.

Fascia Iliaca Block - Saline

Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of Saline.

Group Type SHAM_COMPARATOR

Saline

Intervention Type DRUG

Fascia Iliaca Block

Intervention Type PROCEDURE

Ultrasound-guided regional anesthesia block to the groin area.

Interventions

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.2% Ropivacaine

Intervention Type DRUG

Saline

Intervention Type DRUG

Fascia Iliaca Block

Ultrasound-guided regional anesthesia block to the groin area.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists' (ASA) score I, II or III
* Scheduled for elective total hip arthroplasty

Exclusion Criteria

* Contraindication to regional anesthesia (allergy to local anesthetic, coagulopathy, infection or malignancy in the area)
* Neurologic disorder affecting the ability to sense pain
* Long term opioid use or chronic pain disorder
* History of drug or alcohol abuse
* Patient refusal
* Pregnancy
* Revision procedures
* General anesthetic
* Psychiatric or mental conditions that may affect assessment of outcomes
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saskatoon Health Region

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Jacelyn Larson

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacelyn Larson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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Saskatoon City Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Chelly JE, Ben-David B, Williams BA, Kentor ML. Anesthesia and postoperative analgesia: outcomes following orthopedic surgery. Orthopedics. 2003 Aug;26(8 Suppl):s865-71. doi: 10.3928/0147-7447-20030802-08.

Reference Type RESULT
PMID: 12934742 (View on PubMed)

Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

Reference Type RESULT
PMID: 12873949 (View on PubMed)

Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.

Reference Type RESULT
PMID: 9479711 (View on PubMed)

Mitchell ME. Regional anesthesia for hip surgery. Techniques in Regional Anesthesia and Pain Management 3(2): 94-106, 1999.

Reference Type RESULT

Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13.

Reference Type RESULT
PMID: 2589650 (View on PubMed)

Dolan J, Williams A, Murney E, Smith M, Kenny GN. Ultrasound guided fascia iliaca block: a comparison with the loss of resistance technique. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):526-31. doi: 10.1016/j.rapm.2008.03.008.

Reference Type RESULT
PMID: 19258967 (View on PubMed)

Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.

Reference Type RESULT
PMID: 17413915 (View on PubMed)

Godoy Monzon D, Iserson KV, Vazquez JA. Single fascia iliaca compartment block for post-hip fracture pain relief. J Emerg Med. 2007 Apr;32(3):257-62. doi: 10.1016/j.jemermed.2006.08.011. Epub 2007 Feb 8.

Reference Type RESULT
PMID: 17394987 (View on PubMed)

Other Identifiers

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Bio 13-314

Identifier Type: -

Identifier Source: org_study_id