Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

University Health Network, Toronto

Status: Completed

Conditions: Upper Limb Surgery; Iliac Crest Bone Harvest

Treatments: Drug: Placebo Arm; Drug: Active treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01133730

10-0200-A

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

Active treatment group

Experimental group

Description:

Ultrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine

Treatment:

Drug: Active treatment

Placebo arm

Placebo Comparator group

Description:

Ultrasound-guided TFP block with 20ml of 5% dextrose solution

Treatment:

Drug: Placebo Arm