Cathepos: Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04011839
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 17.8
• Patients Per Site Per Month: 16.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: Levobupivacaïne

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery
• Actual Study Start Date: Jun 7, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. Comparison between sensory Block Quality and motor Block deep [Day1 to Day 3]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de NIMES	Nimes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT04011839
• Other Study ID Numbers: Local/2018/JL-01
• First Posted: Jul 9, 2019
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Levobupivacaine

Study Results

No Results Posted as of Feb 18, 2022