Overview

Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Pregabalin
Criteria
Inclusion Criteria:

- Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia
(neuroaxial with or without peripheral nerve block).

- Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity
to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as
part of the standard of care.

- The subject's preoperative health is graded as American Society of Anesthesiology
Class 1 to Class 3

Exclusion Criteria:

- Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or
subjects with planned second knee total knee arthroplasty at time of present
procedure.

- Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing
spondylitis, psoriatic arthritis); Lyme disease.

- Subjects with fibromyalgia and or other chronic pain syndromes