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Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery (Cathepos)
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 |
|---|---|
| Analgesia | Drug: Levobupivacaïne |
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery |
| Estimated Study Start Date : | April 1, 2021 |
| Estimated Primary Completion Date : | July 2022 |
| Estimated Study Completion Date : | July 2022 |
- Comparison between sensory Block Quality and motor Block deep [ Time Frame: Day1 to Day 3 ]Composite score between 0 to 2 for Sensory Block and 0 to 2 for motor Block
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 2, 2019 | ||||
| First Posted Date | July 9, 2019 | ||||
| Last Update Posted Date | December 19, 2020 | ||||
| Estimated Study Start Date | April 1, 2021 | ||||
| Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Comparison between sensory Block Quality and motor Block deep [ Time Frame: Day1 to Day 3 ] Composite score between 0 to 2 for Sensory Block and 0 to 2 for motor Block
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery | ||||
| Official Title | Evaluation of Perineural Catheterization Practices in Postoperative Orthopedic Surgery | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition | Analgesia | ||||
| Intervention | Drug: Levobupivacaïne
Use of Levobupivacaïne instead ropivacaïne
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Not yet recruiting | ||||
| Estimated Enrollment |
300 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | July 2022 | ||||
| Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04011839 | ||||
| Other Study ID Numbers | Local/2018/JL-01 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Centre Hospitalier Universitaire de Nīmes | ||||
| Study Sponsor | Centre Hospitalier Universitaire de Nīmes | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Centre Hospitalier Universitaire de Nīmes | ||||
| Verification Date | December 2020 | ||||
