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

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

— TFP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398474
• Other study ID #: 2014-003383-21
• Status: Completed
• Phase: Phase 4
• Start date: May 12, 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• TFP block ropivacaine

• ropivacaine infiltration of the iliac crest bone

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption 24 hours after the surgery		24 hours