Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

Study Overview
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Brief Summary
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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.

Official Title
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The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting

Conditions
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Upper Limb Surgery, Iliac Crest Bone Harvest

Intervention / Treatment
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* Drug: Active treatment
* Drug: Placebo Arm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment group<br>Ultrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine | Drug: Active treatment<br>* US-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine<br>|
| Placebo Comparator: Placebo arm<br>Ultrasound-guided TFP block with 20ml of 5% dextrose solution | Drug: Placebo Arm<br>* US-guided TFP block with 20ml of 5% dextrose solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | 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 | 7 days | 
| Pain measures | 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) | 48 hours | 
| Time of block performance | 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) | 6 hours | 
| Complications | TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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.