Clinical trial

Analgesic Effect of Ropivacaine Hydrochloride Combined With Hydromorphone Hydrochloride for Combined Spinal-epidural Anesthesia After Total Knee Arthroplasty

Name
2ed hosp JLU ana dept
Description
The aim of this study is to investigate the continuous analgesic effect and side effects of ropivacaine combined with hydromorphone for combined spinal-epidural anesthesia(CSEA) after total knee arthroplasty and to explore its clinical application value. To observe whether hydromorphone combined with ropivacaine can promote the rapid recovery of patients.
Trial arms
Trial start
2022-10-27
Estimated PCD
2023-11-30
Trial end
2023-11-30
Status
Completed
Treatment
Hydromorphone was injected into the subarachnoid space
The dose of hydromorphone is 50 micrograms
Arms:
Hydromorphone group
Size
136
Primary endpoint
Incidence of moderate to severe pain at rest at 6, 12, 18, and 24 hours after anesthesia.
6, 12, 18, and 24 hours after anesthesia
Incidence of moderate to severe pain with movement at 6, 12, 18, and 24 hours after anesthesia.
6, 12, 18, and 24 hours after anesthesia
Eligibility criteria
Inclusion Criteria: * Age between 55 and 80 years old. * ASA grade I to III. * BMI:20-29kg/m2. * No recent use of sedatives, opioids, or other analgesics. * There was no contraindication of spinal anesthesia, severe dysfunction of heart, lung and other important organs or serious systemic diseases. * Patients were willing to participate in the study and signed the informed consent. Exclusion Criteria: * The patient has mental illness or cannot cooperate with the completion of spinal anesthesia. * The patient had a history of spinal surgery and spinal deformity. * Patients had a history of opioid intolerance or adverse reactions. * puncture site infection, coagulopathy or recent use of anticoagulant drugs. * History of allergy to local anesthetics. * Failed puncture. * Unable to cooperate to complete the research process.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The participants, the surgeon, the surgical nurse, the data collector, and the anesthesiologist administering anesthesia were not aware of the patient groups', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 136, 'type': 'ACTUAL'}}
Updated at
2024-01-24

1 organization

1 product

1 indication