Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

Viatris

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain; Osteoarthritis

Treatments: Drug: pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442546

A0081133

Details and patient eligibility

About

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.

Enrollment: 307 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

307 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin

2

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin

3

Placebo Comparator group

Treatment:

Drug: Placebo