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

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Ultrasound Guided Fascia Iliaca Block for Postoperative Analgesia After Elective Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108847
• Other study ID #: Bio 13-314
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: November 10, 2016
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2016
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Fascia Iliaca Block

Intervention

Drug:
• .2% Ropivacaine

• Saline

Procedure:
• Fascia Iliaca Block
Ultrasound-guided regional anesthesia block to the groin area.

Locations

Country	Name	City	State
Canada	Saskatoon City Hospital	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatoon Health Region

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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):534-40, table of contents. — View 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. — View 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. Review. — View 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. Erratum in: Anesth Analg 1990 Apr;70(4):474. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative opioid consumption	Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison	12 hours after surgery	No
Primary	Cumulative opioid consumption	Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison	24 hours after surgery	No
Secondary	Cumulative opioid consumption	Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison	4, 8, and 48 hours after surgery	No
Secondary	Verbal pain score (static and dynamic)	Pain score 0-10 with 10 being worst possible pain	PACU, 4, 8, 12, 24, and 48 hours after surgery	No
Secondary	Opioid side effect (nausea/vomiting, pruritus, constipation, urinary retention, sedation)	Presence of each side effect documented as "yes" or "no". Sedation will be assessed by the Ramsay Sedation Scale.	PACU, 4, 8, 12, 24, and 48 hours after surgery	No
Secondary	Overall patient satisfaction	Satisfaction rated as: very dissatisfied, dissatisfied, neutral, satisfied, or very satisfied	48 hours after surgery	No