Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery

NCT04011839 | Completed

• 1 other identifier: Local/2018/JL-01
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous peripheral nerve blocks are considered as the gold standard for postoperative analgesia in orthopaedic surgery (shoulder, knee, foot). These techniques are also used in chronic pain. The main disadvantage of these techniques is that they can drive a more or less deep motor block that slows down the rehabilitation process. This disadvantage could be prevented (or minimized) by adapting the protocol for administering local anesthetics or by changing molecules (levobupivacaine 0.625 mg/ml instead of ropivacaine 2 mg/ml). There is no literature comparing the effectiveness of the sensory block and its impact on the motor block according to the administration protocol and/or the type of local anesthetics. The main judgement criterion of such a study could be a composite criterion crossing the quality of the sensory block and the depth of the motor blockades, the ideal being to have a perfect sensory block without any motor block.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Comparison between sensory Block Quality and motor Block deep

  Composite score between 0 to 2 for Sensory Block and 0 to 2 for motor Block

  Day1 to Day 3

Interventions

Levobupivacaïne DRUG

Use of Levobupivacaïne instead ropivacaïne

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing scheduled orthopedic surgery for which perinervous catheter analgesia is usually indicated (complex shoulder, elbow, femur, knee, foot surgery) will be included.

You may qualify if:

• \>18 years old
• ASA score 1 to 4
• Scheduled orthopaedic surgery
• consent to participate

You may not qualify if:

• Pregnant, parturient, or breastfeeding woman
• Emergency situation
• Contraindications to local anaesthesia
• Patient refusal

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de NIMES

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 9, 2019
• Study Start: June 7, 2021
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

FR (1)