Trial · NCT01333956
Effects of Pregabalin on Pain After Total Knee Arthroplasty
NCT01333956, Phase 1, Phase 2, Completed, Hospital for Special Surgery, New York; results first posted 2016-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Pregabalin on Pain After Total Knee Arthroplasty. Trials, record NCT01333956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01333956
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Pregabalin on Pain After Total Knee Arthroplasty
- NCT number
- NCT01333956
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Hospital for Special Surgery, New York
- Conditions
- Primary Total Knee Arthroplasty
- Interventions
- Pregabalin 50mg, Pregabalin 100mg, Pregabalin 150mg, Placebo
- First posted
- 2011-04-12
- Last updated
- 2016-05-18
- Results first posted
- 2016-05-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Postoperative Pain | 2 weeks postoperatively | Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable). |
| Secondary | Opioid-Related Symptom Distress Score | 2 weeks postoperatively | Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high). |
| Secondary | Self-assessed Sedation and Confusion | 1 day postoperatively | Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1) |
| Secondary | Numeric Rating Scale (NRS) | 3 months | NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months) |
| Secondary | Neuropathic Pain | 3 months | Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes. |
| Secondary | Opioid Usage | 3 months | Opioid Usage (POD1, POD 3, 2 weeks, 3 months) |
| Secondary | Satisfaction | 2 weeks | Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Postoperative Pain | 2 weeks postoperatively | units on a scale | MEAN | |
| SECONDARY | Opioid-Related Symptom Distress Score | 2 weeks postoperatively | units on a scale | MEDIAN | |
| SECONDARY | Self-assessed Sedation and Confusion | 1 day postoperatively | percentage of patients | NUMBER | |
| SECONDARY | Numeric Rating Scale (NRS) | 3 months | units on a scale | MEAN | |
| SECONDARY | Neuropathic Pain | 3 months | units on a scale | MEDIAN | |
| SECONDARY | Opioid Usage | 3 months | mg | MEAN | |
| SECONDARY | Satisfaction | 2 weeks | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Postoperative Pain | Control | POD14 Pain score with flexion | 4 | Standard Deviation 2.3 | units on a scale |
| Postoperative Pain | 50mg Arm | POD14 Pain score with flexion | 4.8 | Standard Deviation 2.1 | units on a scale |
| Postoperative Pain | 100mg Arm | POD14 Pain score with flexion | 4.5 | Standard Deviation 2.4 | units on a scale |
| Postoperative Pain | 150mg Arm | POD14 Pain score with flexion | 4.0 | Standard Deviation 2.1 | units on a scale |
| Postoperative Pain | Control | POD14 Pain score with ambulation | 3.6 | Standard Deviation 2.0 | units on a scale |
| Postoperative Pain | 50mg Arm | POD14 Pain score with ambulation | 3.8 | Standard Deviation 1.6 | units on a scale |
| Postoperative Pain | 100mg Arm | POD14 Pain score with ambulation | 3.5 | Standard Deviation 1.8 | units on a scale |
| Postoperative Pain | 150mg Arm | POD14 Pain score with ambulation | 3.1 | Standard Deviation 1.9 | units on a scale |
| Postoperative Pain | Control | POD14 Pain score at rest | 2.9 | Standard Deviation 2.3 | units on a scale |
| Postoperative Pain | 50mg Arm | POD14 Pain score at rest | 2.9 | Standard Deviation 2.0 | units on a scale |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 30 | |
| Overall Study | STARTED | 50mg Arm | 30 | |
| Overall Study | STARTED | 100mg Arm | 30 | |
| Overall Study | STARTED | 150mg Arm | 30 | |
| Overall Study | COMPLETED | Control | 28 | |
| Overall Study | COMPLETED | 50mg Arm | 26 | |
| Overall Study | COMPLETED | 100mg Arm | 29 | |
| Overall Study | COMPLETED | 150mg Arm | 28 | |
| Overall Study | NOT COMPLETED | Control | 2 | |
| Overall Study | NOT COMPLETED | 50mg Arm | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | ||
| Total, all-cause mortality | 50mg Arm | ||
| Total, all-cause mortality | 100mg Arm | ||
| Total, all-cause mortality | 150mg Arm | ||
| Total, other adverse events | Control | 0 | 30 |
| Total, other adverse events | 50mg Arm | 0 | 30 |
| Total, other adverse events | 100mg Arm | 0 | 30 |
| Total, other adverse events | 150mg Arm | 0 | 30 |
| Total, serious adverse events | Control | 0 | 30 |
| Total, serious adverse events | 50mg Arm | 0 | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26170351 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01333956
GET https://conductscience.org/api/trials/v1/NCT01333956/results?page=2