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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
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 20, 2015
Last Updated
November 12, 2019
Sponsor
Rennes University Hospital
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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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