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The Optimal Dosage of Ropivacaine for Arthroscopic Knee Surgery

The Optimal Dosage of Ropivacaine for Arthroscopic Knee Surgery

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04759742
Enrollment
115
Registered
2021-02-18
Start date
2021-03-01
Completion date
2023-06-01
Last updated
2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroscopic Knee Surgery, Combined Spinal Epidurai Anesthesia, ED50, ED95, Ropivacaine

Brief summary

Fast-track Surgery (FTS ) refers to the application of various proven effective methods in perioperative period to reduce stress and complications and accelerate the recovery of patients.Nowadays, FTS has been successfully applied in clinical practice.FTS truly embodies the concept of patient-centered and the direction of medical development. Lower limb joint damage (the meniscus, and patellar ligament, etc.) is the joint movement orthopedic common disease, often characterized by joint swelling, pain, sports relaxation instability, thigh muscle atrophy, most can't continue to pursue the original movement, even unbend and flexor limited activity, result in patients with walking difficulties, serious impact on the patient's quality of life.Practice has proved that minimally invasive surgery under arthroscopy is the best way to treat such injuries. According to literature reports, the average hospital stay after arthroscopy is 5\ 7 days, while successful application of FTS can shorten it to 2\ 3 days. Anesthesia plays an important role in the process of FTS.Compared with general anesthesia, intra-spinal anesthesia can effectively reduce the incidence of postoperative complications in patients, such as ventilator-related lung injury, deep vein thrombosis, cardiovascular and cerebrovascular accidents, and acute renal failure.Ropivacaine is a long-acting amide local anesthetic. Compared with bupivacaine, it is more and more widely used in spinal anesthesia due to its advantages of lower degree of motor nerve block and weaker toxicity to central nervous system and cardiac.However, the optimal dosage of ropivacaine for arthroscopic surgery is still unclear. Conventional dosage makes patients unable to move 2-4h after surgery and unable to urinate autonomically. Therefore, this study aims to optimize the dosage of ropivacaine for spinal anesthesia and enable patients to recover motor function at an early stage.

Interventions

DRUGropivacaine

According to previous clinical experience, 0.5% ropivacaine was given in the subarachnoid cavity, and the initial dose was set at 2.5 mL (12.5mg). Dixon's up-and down method was adopted to adjust or down-adjust the dose of ropivacaine in the next patient according to the experimental results of the previous patient, and the adjusted dose was 0.1 mL (0.5mg).

Sponsors

Yanchao Yang
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing elective arthroscopic knee surgery * ASA: grade I to III

Exclusion criteria

* There are contraindications to spinal anesthesia * Allergic to local anesthetics * Patient refused

Design outcomes

Primary

MeasureTime frameDescription
the median effective dose (ED) of ropivacaine in knee arthroscopic surgeryfrom preoperative to postoperative 24 hoursThe primary outcome of this present study was the median effective dose (ED) of ropivacaine in knee arthroscopic surgery to allow immediate postoperative mobilization as well as adequate anesthesia during surgery.The up and down method as described by Dixon and Massey was used.This is a sequential allocation model in which patients received a dose of ropivacaine according to the outcome of the preceding patient. A starting dose of the test sequence was set to 12.5 mg ropivacaine .The dose of ropivacaine in the next patient was increased or decreased according to the experimental results of the previous patient, and the adjusted dose was 0.5mg.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026