Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb SurgeryPhase 4TFPNCT02398474
Ultrasound TFP (Transversalis Fascia Plane) for Analgesia After Iliac Crest Bone Graft Harvest
A Phase 4 study testing TFP block ropivacaine and ropivacaine infiltration of the iliac crest bone in people with Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery, run by Rennes University Hospital at 1 site in France.
Trial summary
Iliac crest bone graft harvest is associated with acute pain that can lead to chronic postoperative pain. Local anesthetic infiltration and regional anesthesia could be of interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the associated risk of chronic postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery
- What is being tested?
- TFP block ropivacaine and ropivacaine infiltration of the iliac crest bone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2015to Dec 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients scheduled for iliac crest bone graft harvest during upper or lower limb surgery
Who cannot join
- Allergy to ropivacaine, propofol, paracetamol, remifentanil, morphine, cisatracurium, ketoprofene, nefopam
- Weight < 50 kg
- Pregnancy
- Severe psychiatric disorder
- Paraplegia or tetraplegia
- Spinal anesthesia
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- Contra indication to ketoprofene: age ≥ 75 years, renal insufficiency (creatinine clearance < 50 ml/min), active gastric ulcer, past of asthma with NSAID
- Contra indication to nefopam: severe cardiac insufficiency, glaucoma, prostate hypertrophy, epilepsy
- Contra indication to paracetamol: severe hepatic insufficiency
- Severe respiratory insufficiency
- Abnormal hemostasis or anticoagulant treatment
- Chronic use of morphine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intérêt du TFP (Transversalis Fascia Plane) Bloc échoguidé Pour l'analgésie du prélèvement Osseux de crête Iliaque
Iliac crest bone graft harvest is associated with acute pain that can lead to chronic postoperative pain. Local anesthetic infiltration and regional anesthesia could be of interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the associated risk of chronic postoperative pain. In this surgery, local anesthetic infiltration of the iliac crest is associated with a pain reduction compare with placebo.
Some studies have shown the benefit of a TAP (transversus abdominal block) for postoperative analgesia after iliac crest bone graft harvest. The TFP block (transversalis fascia plane block) has been recently described. Considering the nerves trajectories, the TFP block is probably anatomically the most appropriate block for analgesia after iliac crest bone graft harvest.
The aim of this study is therefore to assess the benefit of an ultrasound TFP block for analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration Design is prospective, randomized, double blind, controlled study
- Being tested
- TFP block ropivacaine, ropivacaine infiltration of the iliac crest bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFP block ropivacaineDrug
ropivacaine infiltration of the iliac crest boneDrug
| Study group | Role | What they receive |
|---|---|---|
| iliac crest bone graft with a TFP block | Experimental | Regional anesthesia (RA) for the upper or lower limb depending on the surgery + general anesthesia (GA) + TFP block Receives: Drug: TFP block ropivacaine |
| local anesthetic infiltration of the surgical site. | Active comparator | RA for the upper or lower limb depending on the surgery + GA + ropivacaine infiltration of the iliac crest bone Receives: Drug: ropivacaine infiltration of the iliac crest bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption 24 hours after the surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study start12 May 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb SurgeryStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398474
- Sponsor's protocol ID
- 2014-003383-21
- Other IDs
- 2014
- Acronym
- TFP
- Status last verified
- Jul 2019
- First submitted
- 20 Mar 2015
- Last updated
- 13 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt du TFP (Transversalis Fascia Plane) Bloc échoguidé Pour l'analgésie du prélèvement Osseux de crête Iliaque
- ClinicalTrials.gov ID
- NCT02398474
- Acronym / sponsor ID
- TFP / 2014-003383-21
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 12 May 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Mar 2015 (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.
Iliac crest bone graft harvest is associated with acute pain that can lead to chronic postoperative pain. Local anesthetic infiltration and regional anesthesia could be of interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the associated risk of chronic postoperative pain. In this surgery, local anesthetic infiltration of the iliac crest is associated with a pain reduction compare with placebo.
Some studies have shown the benefit of a TAP (transversus abdominal block) for postoperative analgesia after iliac crest bone graft harvest. The TFP block (transversalis fascia plane block) has been recently described. Considering the nerves trajectories, the TFP block is probably anatomically the most appropriate block for analgesia after iliac crest bone graft harvest.
The aim of this study is therefore to assess the benefit of an ultrasound TFP block for analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration Design is prospective, randomized, double blind, controlled study
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 |
|---|---|---|
| iliac crest bone graft with a TFP block | Experimental | Drug: TFP block ropivacaineRegional anesthesia (RA) for the upper or lower limb depending on the surgery + general anesthesia (GA) + TFP block |
| local anesthetic infiltration of the surgical site. | Active comparator | Drug: ropivacaine infiltration of the iliac crest boneRA for the upper or lower limb depending on the surgery + GA + ropivacaine infiltration of the iliac crest bone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Patients scheduled for iliac crest bone graft harvest during upper or lower limb surgery
Key exclusion criteria (12 listed)
- Allergy to ropivacaine, propofol, paracetamol, remifentanil, morphine, cisatracurium, ketoprofene, nefopam
- Weight < 50 kg
- Pregnancy
- Severe psychiatric disorder
- Paraplegia or tetraplegia
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 |
|---|---|---|
| TFP block ropivacaine | Drug | iliac crest bone graft with a TFP block |
| ropivacaine infiltration of the iliac crest bone | Drug | local anesthetic infiltration of the surgical site. |
Primary outcome
Morphine consumption 24 hours after the surgery
Time frame: 24 hours
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 13 Nov 2019.
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 Phase 4 study testing TFP block ropivacaine and ropivacaine infiltration of the iliac crest bone in people with Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery, run by Rennes University Hospital at 1 site in France.
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 2 inclusion and 12 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 13 Nov 2019. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Morphine consumption 24 hours after the surgery (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 13 Nov 2019.