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Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01133730
First received: May 27, 2010
Last updated: April 25, 2012
Last verified: May 2010

May 27, 2010
April 25, 2012
August 2010
June 2012   (final data collection date for primary outcome measure)
Opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01133730 on ClinicalTrials.gov Archive Site
  • Opioid consumption [ Time Frame: 7 days ] [ Designated as safety issue: No ]

    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
  • Pain measures [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    • 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)
  • Time of block performance [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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)
  • Complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma)
Same as current
Not Provided
Not Provided
 
Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft
The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Upper Limb Surgery
  • Iliac Crest Bone Harvest
  • Drug: Active treatment
    US-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine
  • Drug: Placebo Arm
    US-guided TFP block with 20ml of 5% dextrose solution
  • Experimental: Active treatment group
    Ultrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine
    Intervention: Drug: Active treatment
  • Placebo Comparator: Placebo arm
    Ultrasound-guided TFP block with 20ml of 5% dextrose solution
    Intervention: Drug: Placebo Arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
December 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Ki Jinn Chin, MD 416 603-5118 kijinn.chin@uhn.on.ca
Canada
 
NCT01133730
10-0200-A
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Not Provided
University Health Network, Toronto
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP