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Ultrasound TFP (Transversalis Fascia Plane) for Analgesia After Iliac Crest Bone Graft Harvest (TFP)

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ClinicalTrials.gov Identifier: NCT02398474
Recruitment Status : Recruiting
First Posted : March 25, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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


Condition or disease Intervention/treatment Phase
Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery Drug: TFP block ropivacaine Drug: ropivacaine infiltration of the iliac crest bone Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intérêt du TFP (Transversalis Fascia Plane) Bloc échoguidé Pour l'analgésie du prélèvement Osseux de crête Iliaque
Study Start Date : April 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: iliac crest bone graft with a TFP block
Regional anesthesia (RA) for the upper or lower limb depending on the surgery + general anesthesia (GA) + TFP block
Drug: TFP block ropivacaine
Active Comparator: local anesthetic infiltration of the surgical site.
RA for the upper or lower limb depending on the surgery + GA + ropivacaine infiltration of the iliac crest bone
Drug: ropivacaine infiltration of the iliac crest bone



Primary Outcome Measures :
  1. Morphine consumption 24 hours after the surgery [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398474


Locations
France
CHU de Rennes Recruiting
Rennes, France
Contact: Beloeil Hélène    02 99 28 43 21      
Sponsors and Collaborators
Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02398474     History of Changes
Other Study ID Numbers: 2014-003383-21
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: March 2015

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents