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

Postoperative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06205199
• Other study ID #: 2ed hosp JLU ana dept
• Status: Completed
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Second Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

Drug:
• Hydromorphone was injected into the subarachnoid space
The dose of hydromorphone is 50 micrograms

Locations

Country	Name	City	State
China	Second Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Total non-steroidal analgesic drug consumption 48 hours after surgery	Non-steroidal analgesic consumption at 48 hours after surgery	Postoperative 48 hours
Secondary	Total opioid analgesic consumption at 48 hours after surgery	Opioid analgesic consumption at 48 hours after surgery	Postoperative 48 hours
Secondary	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
Secondary	Satisfaction with postoperative analgesia	Patient satisfaction with postoperative analgesia;0=unsatisfied, 10=fully satisfied	5 days after surgery
Secondary	Retention time of urinary tube	Retention time of urinary catheter after surgery	5 days after surgery
Secondary	Length of postoperative hospital stay	The hospitalization days after surgery	2 weeks after surgery
Secondary	The incidence of postoperative nausea or vomiting	Nausea and vomiting accounted for the proportion of the whole group	Postoperative 48 hours
Secondary	The incidence of postoperative pruritus	Pruritus accounted for the proportion of the whole group	Postoperative 48 hours
Secondary	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
Secondary	The incidence of intraoperative hypoxemia	SpO2 drop below 90%	During the operation
Secondary	Incidence of intraoperative HR reduction	HR < 45 beats /min	During the operation