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
  Purpose

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 Intervention
Upper Limb Surgery
Iliac Crest Bone Harvest
Drug: Active treatment
Drug: Placebo Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 56
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133730

Contacts
Contact: Ki Jinn Chin, MD 416 603-5118 kijinn.chin@uhn.on.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Ki Jinn Chin, MD    416 603-5118    kijinn.chin@uhn.on.ca   
Contact: Kris Abbas, MD    416 603-5800 ext 6237    kris.abbas@uhn.ca   
Principal Investigator: Ki Jinn Chin, MD         
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01133730     History of Changes
Other Study ID Numbers: 10-0200-A
Study First Received: May 27, 2010
Last Updated: April 25, 2012
Health Authority: Canada: Canadian REB

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:
Raynaud Disease
CREST Syndrome
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Telangiectasis
Scleroderma, Limited
Scleroderma, Systemic
Connective Tissue Diseases
Skin Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014