Ultrasound Guided Fascia Iliaca Block for Pain Control After Elective Hip Replacement Surgery
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedNovember 15, 2016
November 1, 2016
1 year
March 21, 2014
November 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Cumulative opioid consumption
4, 8, and 48 hours after surgery
Verbal pain score (static and dynamic)
PACU, 4, 8, 12, 24, and 48 hours after surgery
Opioid side effect (nausea/vomiting, pruritus, constipation, urinary retention, sedation)
PACU, 4, 8, 12, 24, and 48 hours after surgery
Overall patient satisfaction
48 hours after surgery
Study Arms (2)
Fascia Iliaca Block - Ropivacaine
EXPERIMENTALUltrasound guided fascia iliaca block performed preoperatively with 40 mL of 0.2% ropivacaine.
Fascia Iliaca Block - Saline
SHAM COMPARATORUltrasound guided fascia iliaca block performed preoperatively with 40 mL of Saline.
Interventions
Ultrasound-guided regional anesthesia block to the groin area.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists' (ASA) score I, II or III
- Scheduled for elective total hip arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Saskatchewanlead
- Saskatoon Health Regioncollaborator
Study Sites (1)
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada
Related Publications (8)
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.
PMID: 12934742RESULTApfelbaum 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.
PMID: 12873949RESULTBirnbaum 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.
PMID: 9479711RESULTMitchell ME. Regional anesthesia for hip surgery. Techniques in Regional Anesthesia and Pain Management 3(2): 94-106, 1999.
RESULTDalens 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.
PMID: 2589650RESULTDolan 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.
PMID: 19258967RESULTFoss 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.
PMID: 17413915RESULTGodoy 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.
PMID: 17394987RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacelyn Larson, MD
University of Saskatchewan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
March 21, 2014
First Posted
April 9, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
November 15, 2016
Record last verified: 2016-11