Skip to main content
OpenTrials
Completed

NCT Number: NCT01133730

Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Upper Limb Surgery Iliac Crest Bone Harvest

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active treatment

Drug

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

Placebo arm

Drug

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

Primary outcomes

  1. Opioid consumption

    Time frame: 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 outcomes

  1. Opioid consumption

    Time frame: 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

  2. Pain measures

    Time frame: 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)

  3. Time of block performance

    Time frame: 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)

  4. Complications

    Time frame: 12 months

    TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 31, 2010
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.