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

Rennes University Hospital

Status and phase: Completed; Phase 4

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

Treatments: Drug: TFP block ropivacaine; Drug: ropivacaine infiltration of the iliac crest bone

Study type: Interventional

Funder types: Other

Identifiers

NCT02398474

2014-003383-21

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups

iliac crest bone graft with a TFP block

Experimental group

Description:

Regional anesthesia (RA) for the upper or lower limb depending on the surgery + general anesthesia (GA) + TFP block

Treatment:

Drug: TFP block ropivacaine

local anesthetic infiltration of the surgical site.

Active Comparator group

Description:

RA for the upper or lower limb depending on the surgery + GA + ropivacaine infiltration of the iliac crest bone

Treatment:

Drug: ropivacaine infiltration of the iliac crest bone