Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery

Analgesia Clinical Trial

— Cathepos  

Official title:

Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04011839
• Other study ID #: Local/2018/JL-01
• Status: Recruiting
• Start date: June 7, 2021
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Joel L'HERMITE, MD
• Phone: +3346683050
• Email: joel.lhermite[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• ASA score 1 to 4

• Scheduled orthopaedic surgery

• consent to participate

Exclusion Criteria:

• Pregnant, parturient, or breastfeeding woman

• Emergency situation

• Contraindications to local anaesthesia

• Patient refusal

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Levobupivacaïne
Use of Levobupivacaïne instead ropivacaïne

Locations

Country	Name	City	State
France	CHU de NIMES	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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