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Psoas Compartment Block Versus Fascia Iliaca Block After Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01378949
Recruitment Status : Unknown
Verified June 2011 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2011
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Hillel Yaffe Medical Center

Brief Summary:
A psoas compartment block has been used with good results for postoperative pain relief after total hip arthroplasty (THA). However, case reports describing serious complications after the use of this block, have been reported. The fascia iliaca compartment block (FICB) has been shown to be a reliable block for postoperative pain relief for procedures and injuries involving the hip. The investigators have not found any literature that has compared these two blocks. This study will compare the two blocks when used for post-operative pain relief after THA.

Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine Drug: Morphine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : September 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Active Comparator: PsCB Group
Ultrasound-Guided Psoas Compartment Block will be used in patients for pain relief after THA
Drug: Bupivacaine
Bupivacaine 0.5% with adrenaline 5 mcg/cc

Active Comparator: FICB Group
Ultrasound-Guided Fascia Iliaca Compartment Block will be used in patients for pain relief after THA
Drug: Bupivacaine
Bupivacaine 0.5% with adrenaline 5 mcg/cc

Active Comparator: Patient-Controlled Analgesia
Patient-controlled analgesia will be used for pain relief after THA
Drug: Morphine
Morphine 1 mg/cc




Primary Outcome Measures :
  1. Pain score of patients who have been given FICB for post-operative pain relief after THA [ Time Frame: 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA Class I-III
  • Patients undergoing THA for osteoarthritis

Exclusion Criteria:

  • Skin infections adjacent to block site
  • Allergy to local analgesics
  • Patient unable to understand visual analogue scale (VAS)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378949


Contacts
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Contact: Anatoly Stav, MD 972-4-630-4529 stav@hy.health.gov.il

Locations
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Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Principal Investigator: Anatoly Stav, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center

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Responsible Party: A. Stav, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01378949    
Other Study ID Numbers: 2259-11-HYMC
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Keywords provided by Hillel Yaffe Medical Center:
pain score
Additional relevant MeSH terms:
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Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics