Ultrasound TFP (Transversalis Fascia Plane) for Analgesia After Iliac Crest Bone Graft Harvest (TFP)
Primary Purpose
Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
TFP block ropivacaine
ropivacaine infiltration of the iliac crest bone
Sponsored by
About this trial
This is an interventional treatment trial for Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Patients scheduled for iliac crest bone graft harvest during upper or lower limb surgery
Exclusion Criteria:
- Allergy to ropivacaine, propofol, paracetamol, remifentanil, morphine, cisatracurium, ketoprofene, nefopam
- Weight < 50 kg
- Pregnancy
- Severe psychiatric disorder
- Paraplegia or tetraplegia
- Spinal anesthesia
- 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
Sites / Locations
- CHU de Rennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
iliac crest bone graft with a TFP block
local anesthetic infiltration of the surgical site.
Arm Description
Regional anesthesia (RA) for the upper or lower limb depending on the surgery + general anesthesia (GA) + TFP block
RA for the upper or lower limb depending on the surgery + GA + ropivacaine infiltration of the iliac crest bone
Outcomes
Primary Outcome Measures
Morphine consumption 24 hours after the surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT02398474
First Posted
March 20, 2015
Last Updated
November 12, 2019
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02398474
Brief Title
Ultrasound TFP (Transversalis Fascia Plane) for Analgesia After Iliac Crest Bone Graft Harvest
Acronym
TFP
Official Title
Intérêt du TFP (Transversalis Fascia Plane) Bloc échoguidé Pour l'analgésie du prélèvement Osseux de crête Iliaque
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 12, 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iliac crest bone graft with a TFP block
Arm Type
Experimental
Arm Description
Regional anesthesia (RA) for the upper or lower limb depending on the surgery + general anesthesia (GA) + TFP block
Arm Title
local anesthetic infiltration of the surgical site.
Arm Type
Active Comparator
Arm Description
RA for the upper or lower limb depending on the surgery + GA + ropivacaine infiltration of the iliac crest bone
Intervention Type
Drug
Intervention Name(s)
TFP block ropivacaine
Intervention Type
Drug
Intervention Name(s)
ropivacaine infiltration of the iliac crest bone
Primary Outcome Measure Information:
Title
Morphine consumption 24 hours after the surgery
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Patients scheduled for iliac crest bone graft harvest during upper or lower limb surgery
Exclusion Criteria:
Allergy to ropivacaine, propofol, paracetamol, remifentanil, morphine, cisatracurium, ketoprofene, nefopam
Weight < 50 kg
Pregnancy
Severe psychiatric disorder
Paraplegia or tetraplegia
Spinal anesthesia
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
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Ultrasound TFP (Transversalis Fascia Plane) for Analgesia After Iliac Crest Bone Graft Harvest
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