Upper Limb SurgeryNCT01133730
Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft
A study testing Active treatment in people with Upper Limb Surgery and Iliac Crest Bone Harvest, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Upper Limb Surgery, Iliac Crest Bone Harvest
- What is being tested?
- Active treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting
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
- Being tested
- Active treatment, Placebo Arm
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active treatmentDrug
US-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine
Placebo ArmDrug
US-guided TFP block with 20ml of 5% dextrose solution
| Study group | Role | What they receive |
|---|---|---|
| Active treatment group | Experimental | Ultrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine Receives: Drug: Active treatment |
| Placebo arm | Placebo comparator | Ultrasound-guided TFP block with 20ml of 5% dextrose solution Receives: Drug: Placebo Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (4)
Opioid consumption
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
Measured: 7 days
Pain measures
- 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)
Measured: 48 hours
Time of block performance
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)
Measured: 6 hours
Complications
TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133730
- Sponsor's protocol ID
- 10-0200-A
- Status last verified
- May 2010
- First submitted
- 27 May 2010
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting
- ClinicalTrials.gov ID
- NCT01133730
- Acronym / sponsor ID
- 10-0200-A
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment group | Experimental | Drug: Active treatmentUltrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine |
| Placebo arm | Placebo comparator | Drug: Placebo ArmUltrasound-guided TFP block with 20ml of 5% dextrose solution |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active treatmentUS-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine | Drug | Active treatment group |
| Placebo ArmUS-guided TFP block with 20ml of 5% dextrose solution | Drug | Placebo arm |
Primary outcome
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.
4 secondary outcomes
Opioid consumption
Time frame: 7 days
Pain measures
Time frame: 48 hours
Time of block performance
Time frame: 6 hours
Complications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active treatment in people with Upper Limb Surgery and Iliac Crest Bone Harvest, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.