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Completed

NCT Number: NCT02398474

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

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

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Key information

Conditions

Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Rennes

Rennes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TFP block ropivacaine

Drug

ropivacaine infiltration of the iliac crest bone

Drug

Primary outcomes

  1. Morphine consumption 24 hours after the surgery

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Intérêt du TFP (Transversalis Fascia Plane) Bloc échoguidé Pour l'analgésie du prélèvement Osseux de crête Iliaque

Acronym: TFP

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2015
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.