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

NCT06205199 | Completed

• 1 other identifier: 2ed hosp JLU ana dept
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (2)

• Incidence of moderate to severe pain at rest at 6, 12, 18, and 24 hours after anesthesia.

  The NRS scale was used to evaluate pain scores at rest at 6, 12, 18, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)

  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.

  NRS rating scale was used to evaluate pain score during movement at 6 hours, 12 hours, 18 hours, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)

  6, 12, 18, and 24 hours after anesthesia

Secondary Outcomes (14)

• Sedation and agitation at 6, 12, 18 and 24 hours after anesthesia

  6, 12, 18, and 24 hours after anesthesia

• The number of effective compressions of PCIA at 24 hours after surgery

  Postoperative 24 hours

• The proportion of the required additional analgesia after 24 hours

  Postoperative 24 hours

• Total non-steroidal analgesic drug consumption 48 hours after surgery

  Postoperative 48 hours

• Total opioid analgesic consumption at 48 hours after surgery

  Postoperative 48 hours

Study Arms (2)

Hydromorphone group

EXPERIMENTAL

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

Drug: Hydromorphone was injected into the subarachnoid space

Control group

NO INTERVENTION

Ropivacaine 15 mg was injected into the subarachnoid space

Interventions

Hydromorphone was injected into the subarachnoid space DRUG

The dose of hydromorphone is 50 micrograms

Hydromorphone group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Hospital of Jilin University: lead

Study Sites (1)

Second Hospital of Jilin University

Changchun, Jilin, China

Location

Study Officials

• Dan Tian

  Second Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants, the surgeon, the surgical nurse, the data collector, and the anesthesiologist administering anesthesia were not aware of the patient groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 12, 2024
• Study Start: October 27, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)