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

NCT ID: NCT02398474

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-12
• Study Completion Date: 2018-12-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

TFP block ropivacaine

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

ropivacaine infiltration of the iliac crest bone

Intervention Type: DRUG

Interventions

TFP block ropivacaine

Intervention Type: DRUG

ropivacaine infiltration of the iliac crest bone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Rennes

Rennes, , France

Countries

France

Other Identifiers

2014-003383-21

Identifier Type: -

Identifier Source: org_study_id