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.

Study Overview

• Status: Completed
• Conditions: Upper Limb Surgery; Iliac Crest Bone Harvest
• Intervention / Treatment: Drug: Active treatment; Drug: Placebo Arm

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 27, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): May 31, 2010

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: regional anesthesia; opioid consumption; hand surgery; wrist surgery; ultrasound guided; transversalis fascia plane block; supraclavicular nerve block; iliac crest bone harvest; Upper limb surgery combined with iliac crest bone harvest.
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Skin Diseases; Gastrointestinal Diseases; Connective Tissue Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Calcium Metabolism Disorders; Peripheral Vascular Diseases; Calcinosis; Scleroderma, Systemic; Raynaud Disease; Telangiectasis; Scleroderma, Limited; CREST Syndrome
• Other Study ID Numbers: 10-0200-A