Phase 3
Completed N=307
Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
Source: ClinicalTrials.gov NCT00442546 ↗Enrolled (actual)
307
Serious AEs
9.3%
Results posted
Aug 2010
Primary outcomePrimary: Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf) — 7.041; 6.740; 7.079 scores on a scale — p=0.9185
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf) |
7.041; 6.740; 7.079 | 0.9185 |
| SECONDARY Cumulative Total Amount of Opioids Used During the Entire Hospital Stay |
151.790; 152.306; 167.854; 86.402; 93.846; 122.830 | 0.4091 |
| SECONDARY Opioids Used Post Discharge |
30.255; 27.692; 26.119; 37.130; 37.507; 34.271 | 0.3602 |
| SECONDARY Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) |
235.175; 1442.025; 1425.825; 32.961; 53.432; 27.189 | 0.0656 |
| SECONDARY Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] |
498.613; 797.463; 992.613; 603.496; 665.574; 630.787 | 0.1996 |
| SECONDARY Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups |
862.350; 983.850 | 0.9341 |
| SECONDARY Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group |
— | — |
| SECONDARY Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4 |
650.000; 22.100 | <0.0001 sig |
| SECONDARY Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4 |
— | — |
| SECONDARY Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET |
513.163 | — |
| SECONDARY Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET |
— | — |
| SECONDARY The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score |
0.767; 0.808; 0.888; 0.782; 0.779; 0.908 | 0.1661 |
| SECONDARY The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score |
0.579; 0.590; 0.621; 0.642; 0.624; 0.695 | 0.5791 |
| SECONDARY The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score |
0.671; 0.788; 0.836; 0.810; 0.769; 0.918 | 0.1078 |
| SECONDARY The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score |
0.669; 0.727; 0.778; 0.743; 0.722; 0.838 | 0.1949 |
| SECONDARY Total Clinically Meaningful Event (CME) Score |
0.822; 0.817; 0.772; 0.814; 0.834; 0.789 | 0.8071 |
| SECONDARY Pain Interference Index Score as Measured by the m-BPI-sf |
3.427; 3.488; 3.887; 2.969; 2.814; 3.037 | 0.1537 |
| SECONDARY Pain Interference With Relations With People as Measured by the m-BPI-sf |
1.837; 1.716; 2.624; 1.566; 1.370; 1.671 | 0.0359 sig |
| SECONDARY Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf |
3.487; 3.769; 3.744; 2.945; 2.802; 2.953 | 0.5786 |
| SECONDARY Pain Interference With General Activity as Measured by the m-BPI-sf |
3.794; 4.499; 4.764; 3.254; 3.526; 3.524 | 0.0284 sig |
| SECONDARY Pain Interference With Mood as Measured by the m-BPI-sf |
2.588; 2.418; 3.354; 2.640; 2.115; 2.554 | 0.0613 |
| SECONDARY Pain Interference With Walking Ability as Measured by the m-BPI-sf |
4.918; 4.728; 4.982; 3.297; 3.344; 3.425 | 0.8868 |
| SECONDARY Pain Interference With Normal Work as Measured by the m-BPI-sf |
4.879; 4.738; 4.873; 4.010; 3.539; 3.831 | 0.9912 |
| SECONDARY Pain Interference With Sleep as Measured by the m-BPI-sf |
2.696; 2.642; 3.307; 3.139; 3.015; 3.587 | 0.1448 |
| SECONDARY Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) |
7.217; 7.002; 8.770; 7.477; 7.290; 7.201 | 0.0476 sig |
| SECONDARY Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS |
5.712; 4.845; 6.748; 4.961; 4.614; 4.918 | 0.1486 |
| SECONDARY Current Pain During the Hospital Stay Assessed by the Pain NRS |
4.940; 3.554; 4.363; 5.083; 4.529; 5.119 | 0.2211 |
| SECONDARY Pain-Related Sleep Interference Post Surgery |
4.452; 3.671; 5.481; 3.830; 3.408; 4.027 | 0.0388 sig |
| SECONDARY Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery |
6.133; 7.103; 6.992; 6.974; 3.272; 6.085 | 0.7958 |
| SECONDARY Timed Up-and-Go (TUG) |
76.153; 79.973; 82.964; 80.027; 79.548; 86.842 | 0.5736 |
| SECONDARY Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee |
54.877; 60.744; 55.738; 69.981; 73.370; 69.178 | 0.7742 |
| SECONDARY ROM Assessment of the Passive Flexion of the Surgical Knee |
66.720; 71.523; 64.991; 77.714; 81.322; 76.813 | 0.5117 |
| SECONDARY Time From End of Surgery to Meet Hospital Discharge Criteria |
106.802; 112.966; 95.531 | 0.4365 |
| SECONDARY Time From End of Surgery to Actual Discharge |
75.709; 73.906; 78.451 | 0.4024 |
| SECONDARY Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) |
79.897; 80.706; 77.550; 85.274; 85.294; 80.148 | 0.3483 |
| SECONDARY Satisfaction With Medication Characteristics Measured by the PTSS |
85.733; 85.732; 81.556; 91.880; 87.869; 84.583 | 0.0739 |
| SECONDARY Satisfaction With Medication Efficacy Measured by the PTSS |
74.156; 75.705; 73.577; 78.669; 82.724; 75.713 | 0.8545 |
| SECONDARY Overall Satisfaction Measured by the PTSS |
1.845; 1.654; 1.821; 2.333; 1.667; 1.833 | 0.9405 |
| SECONDARY Overall Pain Relief Measured by the PTSS |
2.260; 1.696; 2.051; 2.333; 1.667; 1.833 | 0.5299 |
| SECONDARY Number of Subjects With Global Evaluation of Study Medication Scores |
31; 27; 19; 31; 46; 39 | 0.2473 |
| SECONDARY Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) |
22; 22; 27; 43; 37; 34 | 0.1509 |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) |
1.348; 0.792; 0.828; 1.091; 1.400; 0.667 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00442546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.