Trial · NCT00729690
Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement
NCT00729690, Phase 3, Completed, Asokumar Buvanendran; results first posted 2012-12-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement. Trials, record NCT00729690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00729690
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement
- NCT number
- NCT00729690
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 48 participants, actual
- Lead sponsor
- Asokumar Buvanendran
- Conditions
- PAIN
- Interventions
- Pregabalin, Pregabalin, Placebo
- First posted
- 2008-08-07
- Last updated
- 2012-12-19
- Results first posted
- 2012-12-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | NRS Pain Score AUC (NRS*hr) - 1st 24 Hours | 24 hours | Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 24 hours after initial dose (0-24hr). AUC measured in NRS pain score points per hour (NRS\*hr). Larger AUC values indicate higher levels of reported pain. |
| Primary | NRS Pain Score AUC (NRS*hr) - 1st 12 Hours | 12 hours Post dose | Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 12 hours after initial dose (0-12hr). AUC measured in NRS pain score points per hour (NRS\*hr). Larger AUC values indicate higher levels of reported pain. |
| Secondary | Active Knee Flexion | PostOp day 2 | The degree of active knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. Active flexion is the unassisted moment of the joint by the subject. On postoperative (PostOp) day 2 |
| Secondary | Passive Knee Flexion | PostOp day 2 | Passive flexion is the moment of the joint with the assistance of a clinician (The clinician or therapist physically hold and moves the knee through it's range of motion). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | NRS Pain Score AUC (NRS*hr) - 1st 24 Hours | 24 hours | All Completed Patients were included in the analysis. | Area (NRS*hr) | MEAN |
| SECONDARY | Active Knee Flexion | PostOp day 2 | All completed patients used. | Degrees | MEAN |
| PRIMARY | NRS Pain Score AUC (NRS*hr) - 1st 12 Hours | 12 hours Post dose | All Completed Patients | Area (NRS*hr) | MEAN |
| SECONDARY | Passive Knee Flexion | PostOp day 2 | All Completed Patients were used | Degrees | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| NRS Pain Score AUC (NRS*hr) - 1st 24 Hours | 1 Multi-Dose Pregabalin | 70.4 | Standard Deviation 34.4 | Area (NRS*hr) | |
| NRS Pain Score AUC (NRS*hr) - 1st 24 Hours | 2 Single-dose Pregabalin | 59.6 | Standard Deviation 31.1 | Area (NRS*hr) | |
| NRS Pain Score AUC (NRS*hr) - 1st 24 Hours | 3 Placebo | 73.4 | Standard Deviation 34.6 | Area (NRS*hr) | |
| Active Knee Flexion | 1 Multi-Dose Pregabalin | 78.1 | Standard Deviation 10.6 | Degrees | |
| Active Knee Flexion | 2 Single-dose Pregabalin | 80.5 | Standard Deviation 10.1 | Degrees | |
| Active Knee Flexion | 3 Placebo | 80.5 | Standard Deviation 7.0 | Degrees | |
| NRS Pain Score AUC (NRS*hr) - 1st 12 Hours | 1 Multi-Dose Pregabalin | 30.1 | Standard Deviation 15.6 | Area (NRS*hr) | |
| NRS Pain Score AUC (NRS*hr) - 1st 12 Hours | 2 Single-dose Pregabalin | 22.7 | Standard Deviation 16.9 | Area (NRS*hr) | |
| NRS Pain Score AUC (NRS*hr) - 1st 12 Hours | 3 Placebo | 27.7 | Standard Deviation 16.7 | Area (NRS*hr) | |
| Passive Knee Flexion | 1 Multi-Dose Pregabalin | 86.5 | Standard Deviation 15.3 | Degrees |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1 Multi-Dose Pregabalin | 16 | |
| Overall Study | STARTED | 2 Single-dose Pregabalin | 16 | |
| Overall Study | STARTED | 3 Placebo | 16 | |
| Overall Study | COMPLETED | 1 Multi-Dose Pregabalin | 16 | |
| Overall Study | COMPLETED | 2 Single-dose Pregabalin | 14 | |
| Overall Study | COMPLETED | 3 Placebo | 14 | |
| Overall Study | NOT COMPLETED | 1 Multi-Dose Pregabalin | 0 | |
| Overall Study | NOT COMPLETED | 2 Single-dose Pregabalin | 2 | |
| Overall Study | NOT COMPLETED | 3 Placebo | 2 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pruritus | Skin and subcutaneous tissue disorders | 1 Multi-Dose Pregabalin | 2 | 16 | 2 |
| other | Pruritus | Skin and subcutaneous tissue disorders | 2 Single-dose Pregabalin | 3 | 16 | 3 |
| other | Pruritus | Skin and subcutaneous tissue disorders | 3 Placebo | 7 | 16 | 7 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 Multi-Dose Pregabalin | ||
| Total, all-cause mortality | 2 Single-dose Pregabalin | ||
| Total, all-cause mortality | 3 Placebo | ||
| Total, other adverse events | 1 Multi-Dose Pregabalin | 2 | 16 |
| Total, other adverse events | 2 Single-dose Pregabalin | 3 | 16 |
| Total, other adverse events | 3 Placebo | 7 | 16 |
| Total, serious adverse events | 1 Multi-Dose Pregabalin | 0 | 16 |
| Total, serious adverse events | 2 Single-dose Pregabalin | 0 | 16 |
| Total, serious adverse events | 3 Placebo | 0 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22156332 | RESULT |
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/NCT00729690
GET https://conductscience.org/api/trials/v1/NCT00729690/registered