Clinical trial NCT02108847: Ultrasound Guided Fascia Iliaca Block for Pain Control After Elective Hip Replacement Surgery
Official title: Ultrasound Guided Fascia Iliaca Block for Postoperative Analgesia After Elective Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Fascia Iliaca Block
Keywords: Arthroplasty, Replacement, Hip
Pain, Postoperative
Nerve Block
Anesthesia, Regional
Fascia Iliaca Block
Ultrasound Guided
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatoon Health Region
First posted: 2014-04-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative opioid consumption
timeFrame: 12 hours after surgery
measure: Cumulative opioid consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Cumulative opioid consumption
timeFrame: 4, 8, and 48 hours after surgery
measure: Verbal pain score (static and dynamic)
timeFrame: PACU, 4, 8, 12, 24, and 48 hours after surgery
measure: Opioid side effect (nausea/vomiting, pruritus, constipation, urinary retention, sedation)
timeFrame: PACU, 4, 8, 12, 24, and 48 hours after surgery
measure: Overall patient satisfaction
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Saskatoon City Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Jacelyn Larson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Mitchell ME. Regional anesthesia for hip surgery. Techniques in Regional Anesthesia and Pain Management 3(2): 94-106, 1999.
citation: 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.
citation: 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.
citation: 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.
citation: 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.