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Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

NCT ID: NCT01133730

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Upper Limb Surgery Iliac Crest Bone Harvest

Keywords

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supraclavicular nerve block regional anesthesia transversalis fascia plane block ultrasound guided opioid consumption iliac crest bone harvest hand surgery wrist surgery Upper limb surgery combined with iliac crest bone harvest.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active treatment group

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

Group Type EXPERIMENTAL

Active treatment

Intervention Type DRUG

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

Placebo arm

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

Group Type PLACEBO_COMPARATOR

Placebo Arm

Intervention Type DRUG

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

Interventions

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Active treatment

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

Intervention Type DRUG

Placebo Arm

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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10-0200-A

Identifier Type: -

Identifier Source: org_study_id