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

Not Applicable

Completed

• Conditions: Postoperative Analgesia
• Interventions: Drug: Hydromorphone was injected into the subarachnoid space

• Registration Number: NCT06205199
• Lead Sponsor: Second Hospital of Jilin University

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.

Study Timeline

• Study Start: 2022-10-27
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Study First Submitted: 2023-12-17
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-12
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydromorphone group	Hydromorphone was injected into the subarachnoid space	Hydromorphone 50 micrograms combined with ropivacaine 15 mg was injected into the subarachnoid space

Primary Outcome Measures

Name	Time	Method
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	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)
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	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China