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Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

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. Identifier: NCT01133730
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : December 15, 2017
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Hand or wrist surgery often requires the use of bony material in order to accomplish any associated reconstructive aspects required for the surgery. The iliac crest is often used as the source of bone for such surgery and harvesting from this site is performed simultaneously with the hand/wrist surgery. In terms of anesthesia, patients typically receive a supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the bone graft, though spinal block may also be performed. This study will look at the use of a transversalis fascia plane (TFP) nerve block (ie, to numb the nerves going to the iliac crest) in combination with a general anesthetic to see if post-operative pain and opioid consumption is reduced using the TFP block.

Condition or disease Intervention/treatment Phase
Upper Limb Surgery Iliac Crest Bone Harvest Drug: Active treatment Drug: Placebo Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting
Actual Study Start Date : August 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Active treatment group
Ultrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine
Drug: Active treatment
US-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine

Placebo Comparator: Placebo arm
Ultrasound-guided TFP block with 20ml of 5% dextrose solution
Drug: Placebo Arm
US-guided TFP block with 20ml of 5% dextrose solution

Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: 24 hours ]
    Opioid consumption in the first 24 hours following ICBG. This will be expressed in terms of milligrams doses of IV morphine. Where other opioids are used, the doses will be converted to the equivalent IV morphine dose using standard opioid dosage conversion tables.

Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: 7 days ]

    Opioid consumption (expressed as milligram doses of IV morphine) in the following phases

    • Intraoperative phase (from start of surgery to end of surgery)
    • Postoperative care unit stay (from admission to discharge)
    • First 48 hours following ICBG

  2. Pain measures [ Time Frame: 48 hours ]
    • Pain scores at the ICBG site, measured using a visual analogue scale (VAS) (scale 0-10) and starting in recovery, then every 4 hrs for the next 48 hrs.
    • Pain at the primary surgical site (VAS 0-10)
    • Duration of block, defined as the time from completion of block performance to the time of onset of increased pain at the ICBG harvest site (as perceived by the patient)

  3. Time of block performance [ Time Frame: 6 hours ]
    Time required to perform the TFP block (defined as the time between placement of the ultrasound probe on the patient, and withdrawal of the block needle)

  4. Complications [ Time Frame: 12 months ]
    TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma)

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. ASA physical status I-III
  2. 18-85 years of age, inclusive
  3. Weight 50kg+
  4. Scheduled for elective upper limb surgery, which can be solely performed under a brachial plexus block, and requiring an ICBG

Exclusion Criteria:

  1. Contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
  2. Pregnancy
  3. History of alcohol or drug dependency/abuse
  4. History of long term opioid intake or chronic pain disorder
  5. History of significant psychiatric conditions that may affect patient assessment
  6. Failure of upper extremity block
  7. Previous iliac crest bone grafting
  8. History of severe pelvic and hip conditions that could interfere with the long-term functional assessments of the study
  9. Inability to understand the informed consent and demands of the study.

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 identifier (NCT number): NCT01133730

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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: University Health Network, Toronto Identifier: NCT01133730     History of Changes
Other Study ID Numbers: 10-0200-A
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: May 2010
Keywords provided by University Health Network, Toronto:
supraclavicular nerve block
regional anesthesia
transversalis fascia plane block
ultrasound guided
opioid consumption
iliac crest bone harvest
hand surgery
wrist surgery
Upper limb surgery combined with iliac crest bone harvest.
Additional relevant MeSH terms:
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CREST Syndrome
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Scleroderma, Limited
Scleroderma, Systemic
Connective Tissue Diseases
Skin Diseases
Calcium Metabolism Disorders
Metabolic Diseases