Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

NCT01133730 | Completed

• 1 other identifier: 10-0200-A
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Surgery; Iliac Crest Bone Harvest

Keywords

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.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Opioid consumption

  7 days

• Pain measures

  48 hours

• Time of block performance

  6 hours

• Complications

  12 months

Study Arms (2)

Active treatment group

EXPERIMENTAL

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

Drug: Active treatment

Placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo Arm

Interventions

Active treatment DRUG

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

Active treatment group

Placebo Arm DRUG

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

Placebo arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 15, 2017

Record last verified: 2010-05

Locations

CA (1)