A Phase 4 interventional study of Opioid-Sparing Protocol and Opioid-Based Patient Controlled Analgesia in Knee Replacement, Postoperative Pain and Opioid Use, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-21.
Sponsored by Taipei Veterans General Hospital, Taiwan · Phase 4, Interventional, and Treatment
The concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. Historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. Compared to the Opioid-Based patient controlled analgesia(PCA), the opioid-sparing protocol may have benefits to decrease the concerns of the opioid use and opioid-related complication and provides the equivalent efficacy for pain control. The purpose of this trial in to provide a novel opioid-sparing protocol (OSP) to evaluate the efficacy for pain control and reducing the immediate postoperative opioid consumption.
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's planned enrollment of 56 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses.
Drug: Opioid-Sparing Protocol
Preemptive(before incision) and Postoperative: the initial setting was 0.01mg/kg\*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours; adjusted by the PCA staff
Drug: Opioid-Based Patient Controlled Analgesia
After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. In the opioid-sparing group, a dose of Parecoxib sodium 40 mg was administrated through intravenous route before the incision. After the surgery, Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.
Also known as: OSP Protocol
After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. The patient was informed that the intravenous bolus of rescue morphine (4mg) was available every 4 hours if the pain was intolerable. In the PCA group, the device was applied before incision and the initial setting was 0.01mg/kg\*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours. After the surgery, the staff of PCA group would visit the patients and adjusted the dosage. The PCA was removed after 72 hours from the surgery. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.
Also known as: PCA Protocol
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 6 hours
Time frame: Post-operative 6 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 12 hours
Time frame: Post-operative 12 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 24 hours
Time frame: Post-operative 24 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 48 hours
Time frame: Post-operative 48 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 72 hours
Time frame: Post-operative 72 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Post-operative 24 hours
Time frame: Post-operative 24 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Post-operative 48 hours
Time frame: Post-operative 48 hour hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Post-operative 72 hours
Time frame: Post-operative 72 hour hours after surgery
maximum angle of continuous passive motion (CPM) as tolerated (Degrees)
recorded at post-operative 24 hours, 48 hours and 72 hours
Time frame: 0-72 hours after surgery
Cumulative morphine consumption(mg)
recorded at post-operative 24 hours, 48 hours and 72 hours
Time frame: 0-72 hours after surgery
drug-related (opioid) adverse events
nausea/vomiting, dizziness, urinary retention, pruritus, dry mouth, constipation, dyspepsia, GI bleeding, pitting edema over lower extremities, cardiovascular event, respiratory depression, delirium or coma
Time frame: 0-72 hours after surgery
Satisfaction scale (0-100 points)
satisfaction with regard to the efficacy and safety of the pain management protocol.
Time frame: postoperative 2 weeks after surgery
Length of hospital stay (LOS) (Days)
Time from admission to discharge
Time frame: After surgery until discharge (about 3-5 days after surgery)
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Taipei Veterans General Hospital, Taiwan