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

Phase 4

Completed

• Conditions: Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery
• Interventions: Drug: TFP block ropivacaine; Drug: ropivacaine infiltration of the iliac crest bone

• Registration Number: NCT02398474
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-25
• Study Start: 2015-05-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-11-12
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iliac crest bone graft with a TFP block	TFP block ropivacaine	Regional anesthesia (RA) for the upper or lower limb depending on the surgery + general anesthesia (GA) + TFP block
local anesthetic infiltration of the surgical site.	ropivacaine infiltration of the iliac crest bone	RA for the upper or lower limb depending on the surgery + GA + ropivacaine infiltration of the iliac crest bone

Primary Outcome Measures

Name	Time	Method
Morphine consumption 24 hours after the surgery	24 hours

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France