Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

Not Applicable

Completed

• Conditions: Iliac Crest Bone Harvest; Upper Limb Surgery
• Interventions: Drug: Placebo Arm; Drug: Active treatment

• Registration Number: NCT01133730
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-05-31
• Study Start: 2010-08
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo Arm	Ultrasound-guided TFP block with 20ml of 5% dextrose solution
Active treatment group	Active treatment	Ultrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine

Primary Outcome Measures

Name	Time	Method
Opioid consumption	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

Name	Time	Method
Opioid consumption	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
Complications	12 months	TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma)
Pain measures	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)
Time of block performance	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)

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada