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

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain; Opioid Use; Knee Replacement

Treatments: Drug: Opioid-Based Patient Controlled Analgesia; Drug: Opioid-Sparing Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04314505

2020-02-008C

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Opioid Sparing Protocol

Experimental group

Description:

Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses.

Treatment:

Drug: Opioid-Sparing Protocol

Opioid Based Patient Controlled Analgesia

Active Comparator group

Description:

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

Treatment:

Drug: Opioid-Based Patient Controlled Analgesia