The Optimal Dosage of Ropivacaine for Arthroscopic Knee Surgery

NCT ID: NCT04759742

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-06-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group Ropivacaine

The recommended administration concentration of ropivacaine in the subarachnoid space was 0.5% and the dose was 2-3ml (practical clinical anesthesiology). Based on previous clinical experience, the starting dose of ropivacaine was set at 12.5mg (2.5ml) and Dixon's up-and down method was adopted (Dixon WJ, Massey FJ Jr. Introduction to Statistical Analysis. NY: McGraw-Hill;1969. P. 344.) The dose of ropivacaine in the next patient was adjusted to 0.5mg (0.1 mL) according to the results of the previous patient's trial.

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

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).

Interventions

ropivacaine

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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanchao Yang

OTHER

Sponsor Role: lead

Responsible Party

Yanchao Yang

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

junchao Zhu

Role: STUDY_CHAIR

Shengjing Hospital

Locations

Shengjing Hospital

Shengyang, Liaoning, China

Countries

China

Other Identifiers

Arthroscopic anesthesia

Identifier Type: -

Identifier Source: org_study_id