Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01133730

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Limb Surgery Iliac Crest Bone Harvest	Drug: Active treatment Drug: Placebo Arm	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
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)
Complications [12 months]
TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.