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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydromorphone group | Experimental | Hydromorphone 50 micrograms combined with ropivacaine 15 mg was injected into the subarachnoid space |
|
| Control group | No Intervention | Ropivacaine 15 mg was injected into the subarachnoid space |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone was injected into the subarachnoid space | Drug | The dose of hydromorphone is 50 micrograms |
|
| 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 anesthesiaï¼›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 anesthesiaï¼›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 |
| 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 anesthesiaï¼›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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Tian | Second Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Hospital of Jilin University | Changchun | Jilin | China |
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The participants, the surgeon, the surgical nurse, the data collector, and the anesthesiologist administering anesthesia were not aware of the patient groups
| 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 analgesiaï¼›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 |