Postoperative Analgesia
Conditions
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.
Interventions
DRUGHydromorphone was injected into the subarachnoid space
The dose of hydromorphone is 50 micrograms
Sponsors
Second Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participants, the surgeon, the surgical nurse, the data collector, and the anesthesiologist administering anesthesia were not aware of the patient groups
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The incidence of intraoperative hypoxemia | During the operation | SpO2 drop below 90% |
| 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) |
| 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 non-steroidal analgesic drug consumption 48 hours after surgery | Postoperative 48 hours | Non-steroidal analgesic consumption at 48 hours after surgery |
| Total opioid analgesic consumption at 48 hours after surgery | Postoperative 48 hours | Opioid analgesic consumption at 48 hours after surgery |
| 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 |
| 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 postoperative pruritus | Postoperative 48 hours | Pruritus accounted for the proportion of the whole group |
| 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 intraoperative hypotension | During the operation | Systolic blood pressure drops to 20% of basal blood pressure or systolic blood pressure drops below 90mmHg |
Countries
China
Outcome results
None listed