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
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
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
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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:
Genetics Home Reference related topics:
systemic scleroderma
MedlinePlus related topics:
Bone Grafts
U.S. FDA Resources
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:
- ASA physical status I-III
- 18-85 years of age, inclusive
- Weight 50kg+
- Scheduled for elective upper limb surgery, which can be solely performed under a brachial plexus block, and requiring an ICBG
Exclusion Criteria:
- Contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- Pregnancy
- History of alcohol or drug dependency/abuse
- History of long term opioid intake or chronic pain disorder
- History of significant psychiatric conditions that may affect patient assessment
- Failure of upper extremity block
- Previous iliac crest bone grafting
- History of severe pelvic and hip conditions that could interfere with the long-term functional assessments of the study
- Inability to understand the informed consent and demands of the study.
Contacts and Locations
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:
|
CREST Syndrome Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Raynaud Disease 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 May 19, 2013