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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip; Fascia Iliaca Block
• Intervention / Treatment: Drug: Saline; Drug: .2% Ropivacaine; Procedure: Fascia Iliaca Block

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • Saskatoon City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fascia Iliaca Block - Ropivacaine; Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of 0.2% ropivacaine.	Drug: .2% Ropivacaine; Procedure: Fascia Iliaca Block; Ultrasound-guided regional anesthesia block to the groin area.
Sham Comparator: Fascia Iliaca Block - Saline; Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of Saline.	Drug: Saline; Procedure: Fascia Iliaca Block; Ultrasound-guided regional anesthesia block to the groin area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Overall patient satisfaction	Satisfaction rated as: very dissatisfied, dissatisfied, neutral, satisfied, or very satisfied	48 hours after surgery

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatoon Health Region
• Investigators: Principal Investigator: Jacelyn Larson, MD, University of Saskatchewan

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Nerve Block; Fascia Iliaca Block; Anesthesia, Regional; Arthroplasty, Replacement, Hip; Pain, Postoperative; Ultrasound Guided
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Bio 13-314