Analgesic Effect of Ropivacaine Combined With Hydromorphone for CSEA After Total Knee Arthroplasty

NCT ID: NCT06205199

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-27
• Study Completion Date: 2023-11-30

Brief Summary

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.

Detailed Description

For patients undergoing total knee arthroplasty, different spinal anesthesia drugs were injected in the two groups. The spinal anesthetic drugs injected in the hydromorphone group were hydromorphone 50 μg and ropivacaine 15 mg. In the control group, the spinal anesthetic was ropivacaine 15 mg.The differences in analgesia, sedation, and side effects between the hydromorphone group and the control group were analyzed by collecting various data at different times after anesthesia.

Conditions

Postoperative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hydromorphone group

Hydromorphone 50 micrograms combined with ropivacaine 15 mg was injected into the subarachnoid space

Group Type: EXPERIMENTAL

Hydromorphone was injected into the subarachnoid space

Intervention Type: DRUG

The dose of hydromorphone is 50 micrograms

Control group

Ropivacaine 15 mg was injected into the subarachnoid space

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hydromorphone was injected into the subarachnoid space

The dose of hydromorphone is 50 micrograms

Intervention Type: DRUG

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Tian

Role: PRINCIPAL_INVESTIGATOR

Second Hospital of Jilin University

Locations

Second Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

2ed hosp JLU ana dept

Identifier Type: -

Identifier Source: org_study_id