Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

Upper Limb Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133730
• Other study ID #: 10-0200-A
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: December 13, 2017
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• CREST Syndrome
• Iliac Crest Bone Harvest
• Upper Limb Surgery

Intervention

Drug:
• Active treatment
US-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine
• Placebo Arm
US-guided TFP block with 20ml of 5% dextrose solution

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Complications	TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma)	12 months