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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Drug: Hydromorphone was injected into the subarachnoid space

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • Second Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydromorphone group; Hydromorphone 50 micrograms combined with ropivacaine 15 mg was injected into the subarachnoid space	Drug: Hydromorphone was injected into the subarachnoid space; The dose of hydromorphone is 50 micrograms
No Intervention: Control group; Ropivacaine 15 mg was injected into the subarachnoid space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation and agitation at 6, 12, 18 and 24 hours after anesthesia	RASS was used to assess sedation and agitation at 6, 12, 18, and 24 hours after anesthesia；Richmond Agitation and Sedation Scale(RASS,a 10-point scale where -5=unwakeable,0=clear and calm,+4=aggressive)	6, 12, 18, and 24 hours after anesthesia
The number of effective compressions of PCIA at 24 hours after surgery	Effective number of PCIA compressions during the 24 hours after surgery	Postoperative 24 hours
The proportion of the required additional analgesia after 24 hours	The proportion of patients requiring additional analgesia 24 hours after surgery in the whole group	Postoperative 24 hours
Total non-steroidal analgesic drug consumption 48 hours after surgery	Non-steroidal analgesic consumption at 48 hours after surgery	Postoperative 48 hours
Total opioid analgesic consumption at 48 hours after surgery	Opioid analgesic consumption at 48 hours after surgery	Postoperative 48 hours
The proportion of getting out of bed within 48h	The proportion of people who got out of bed 48 hours after operation in the whole group	Postoperative 48 hours
Satisfaction with postoperative analgesia	Patient satisfaction with postoperative analgesia；0=unsatisfied, 10=fully satisfied	5 days after surgery
Retention time of urinary tube	Retention time of urinary catheter after surgery	5 days after surgery
Length of postoperative hospital stay	The hospitalization days after surgery	2 weeks after surgery
The incidence of postoperative nausea or vomiting	Nausea and vomiting accounted for the proportion of the whole group	Postoperative 48 hours
The incidence of postoperative pruritus	Pruritus accounted for the proportion of the whole group	Postoperative 48 hours
The incidence of intraoperative hypotension	Systolic blood pressure drops to 20% of basal blood pressure or systolic blood pressure drops below 90mmHg	During the operation
The incidence of intraoperative hypoxemia	SpO2 drop below 90%	During the operation
Incidence of intraoperative HR reduction	HR < 45 beats /min	During the operation

Collaborators and Investigators

• Sponsor: Second Hospital of Jilin University
• Investigators: Principal Investigator: Dan Tian, Second Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Hydromorphone
• Other Study ID Numbers: 2ed hosp JLU ana dept

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No