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

N/ACompletedNCT06205199

Second Hospital of Jilin University136 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

136

Conditions

Postoperative Analgesia

Interventions

Hydromorphone was injected into the subarachnoid spaceDRUG

The dose of hydromorphone is 50 micrograms

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Second Hospital of Jilin University

Changchun, Jilin, China

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 6, 12, 18, and 24 hours after anesthesia

Secondary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: Postoperative 24 hours

Total non-steroidal analgesic drug consumption 48 hours after surgery

Non-steroidal analgesic consumption at 48 hours after surgery

Data from ClinicalTrials.gov

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