Clinical trial NCT06205199: Analgesic Effect of Ropivacaine Combined With Hydromorphone for CSEA After Total Knee Arthroplasty
Official title: Analgesic Effect of Ropivacaine Hydrochloride Combined With Hydromorphone Hydrochloride for Combined Spinal-epidural Anesthesia After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Analgesia
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 136
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of moderate to severe pain at rest at 6, 12, 18, and 24 hours after anesthesia.
timeFrame: 6, 12, 18, and 24 hours after anesthesia
measure: Incidence of moderate to severe pain with movement at 6, 12, 18, and 24 hours after anesthesia.
timeFrame: 6, 12, 18, and 24 hours after anesthesia
Secondary outcomes:
measure: Sedation and agitation at 6, 12, 18 and 24 hours after anesthesia
timeFrame: 6, 12, 18, and 24 hours after anesthesia
measure: The number of effective compressions of PCIA at 24 hours after surgery
timeFrame: Postoperative 24 hours
measure: The proportion of the required additional analgesia after 24 hours
timeFrame: Postoperative 24 hours
measure: Total non-steroidal analgesic drug consumption 48 hours after surgery
timeFrame: Postoperative 48 hours
measure: Total opioid analgesic consumption at 48 hours after surgery
timeFrame: Postoperative 48 hours
measure: The proportion of getting out of bed within 48h
timeFrame: Postoperative 48 hours
measure: Satisfaction with postoperative analgesia
timeFrame: 5 days after surgery
measure: Retention time of urinary tube
timeFrame: 5 days after surgery
measure: Length of postoperative hospital stay
timeFrame: 2 weeks after surgery
measure: The incidence of postoperative nausea or vomiting
timeFrame: Postoperative 48 hours
measure: The incidence of postoperative pruritus
timeFrame: Postoperative 48 hours
measure: The incidence of intraoperative hypotension
timeFrame: During the operation
measure: The incidence of intraoperative hypoxemia
timeFrame: During the operation
measure: Incidence of intraoperative HR reduction
timeFrame: During the operation
Other outcomes:
Locations:
city: Changchun
country: China
facility: Second Hospital of Jilin University
state: Jilin
Study officials:
affiliation: Second Hospital of Jilin University
name: Dan Tian
role: PRINCIPAL_INVESTIGATOR
References: