Opioid-Sparing Protocol Comparing With Opioid-based Protocol After Bilateral Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

Opioid-Sparing Protocol Using for Postoperative Pain Management Comparing With Opioid-based Patient Control Analgesia After Simultaneous Bilateral Total Knee Arthroplasty: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04314505
• Other study ID #: 2020-02-008C
• Status: Recruiting
• Phase: Phase 4
• Start date: March 20, 2020
• Est. completion date: August 20, 2020

Study information

• Verified date: July 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Hsuan-Hsiao Ma, M.D.
• Phone: 02-28717557
• Email: tyc20192[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: August 20, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• patient with bilateral advanced knee osteoarthritis undergoing simultaneous bilateral total knee arthroplasty surgery

• willing to participate in this study and randomly allocated to either opioid-sparing protocol or PCA protocol.

Exclusion Criteria:

• patient who refused to participate or with contraindication or hypersensitivity to any of the study drugs

• chronic pain disorder (exceeding 50 mg oral morphine equivalence per day at time of recruitment)

• substance abuse (e.g. alcoholism)

• severe renal impairment.

Related Conditions & MeSH terms

• Knee Replacement
• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Opioid-Sparing Protocol
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.
• 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. 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.

Locations

Country	Name	City	State
Taiwan	Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital	Taipei city	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores using numerical rating scale (VAS, 0 to 10) at rest	Post-operative 6 hours	Post-operative 6 hours after surgery
Primary	Pain scores using numerical rating scale (VAS, 0 to 10) at rest	Post-operative 12 hours	Post-operative 12 hours after surgery
Primary	Pain scores using numerical rating scale (VAS, 0 to 10) at rest	Post-operative 24 hours	Post-operative 24 hours after surgery
Primary	Pain scores using numerical rating scale (VAS, 0 to 10) at rest	Post-operative 48 hours	Post-operative 48 hours after surgery
Primary	Pain scores using numerical rating scale (VAS, 0 to 10) at rest	Post-operative 72 hours	Post-operative 72 hours after surgery
Primary	Pain scores using numerical rating scale (VAS, 0 to 10) at motion	Post-operative 24 hours	Post-operative 24 hours after surgery
Primary	Pain scores using numerical rating scale (VAS, 0 to 10) at motion	Post-operative 48 hours	Post-operative 48 hour hours after surgery
Primary	Pain scores using numerical rating scale (VAS, 0 to 10) at motion	Post-operative 72 hours	Post-operative 72 hour hours after surgery
Secondary	maximum angle of continuous passive motion (CPM) as tolerated (Degrees)	recorded at post-operative 24 hours, 48 hours and 72 hours	0-72 hours after surgery
Secondary	Cumulative morphine consumption(mg)	recorded at post-operative 24 hours, 48 hours and 72 hours	0-72 hours after surgery
Secondary	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	0-72 hours after surgery
Secondary	Satisfaction scale (0-100 points)	satisfaction with regard to the efficacy and safety of the pain management protocol.	postoperative 2 weeks after surgery
Secondary	Length of hospital stay (LOS) (Days)	Time from admission to discharge	After surgery until discharge (about 3-5 days after surgery)