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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryNRS Pain Score AUC (NRS*hr) - 1st 24 Hours24 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.
PrimaryNRS Pain Score AUC (NRS*hr) - 1st 12 Hours12 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.
SecondaryActive Knee FlexionPostOp 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
SecondaryPassive Knee FlexionPostOp day 2Passive 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).

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNRS Pain Score AUC (NRS*hr) - 1st 24 Hours24 hoursAll Completed Patients were included in the analysis.Area (NRS*hr)MEAN
SECONDARYActive Knee FlexionPostOp day 2All completed patients used.DegreesMEAN
PRIMARYNRS Pain Score AUC (NRS*hr) - 1st 12 Hours12 hours Post doseAll Completed PatientsArea (NRS*hr)MEAN
SECONDARYPassive Knee FlexionPostOp day 2All Completed Patients were usedDegreesMEAN

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
NRS Pain Score AUC (NRS*hr) - 1st 24 Hours1 Multi-Dose Pregabalin70.4Standard Deviation 34.4Area (NRS*hr)
NRS Pain Score AUC (NRS*hr) - 1st 24 Hours2 Single-dose Pregabalin59.6Standard Deviation 31.1Area (NRS*hr)
NRS Pain Score AUC (NRS*hr) - 1st 24 Hours3 Placebo73.4Standard Deviation 34.6Area (NRS*hr)
Active Knee Flexion1 Multi-Dose Pregabalin78.1Standard Deviation 10.6Degrees
Active Knee Flexion2 Single-dose Pregabalin80.5Standard Deviation 10.1Degrees
Active Knee Flexion3 Placebo80.5Standard Deviation 7.0Degrees
NRS Pain Score AUC (NRS*hr) - 1st 12 Hours1 Multi-Dose Pregabalin30.1Standard Deviation 15.6Area (NRS*hr)
NRS Pain Score AUC (NRS*hr) - 1st 12 Hours2 Single-dose Pregabalin22.7Standard Deviation 16.9Area (NRS*hr)
NRS Pain Score AUC (NRS*hr) - 1st 12 Hours3 Placebo27.7Standard Deviation 16.7Area (NRS*hr)
Passive Knee Flexion1 Multi-Dose Pregabalin86.5Standard Deviation 15.3Degrees

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTED1 Multi-Dose Pregabalin16
Overall StudySTARTED2 Single-dose Pregabalin16
Overall StudySTARTED3 Placebo16
Overall StudyCOMPLETED1 Multi-Dose Pregabalin16
Overall StudyCOMPLETED2 Single-dose Pregabalin14
Overall StudyCOMPLETED3 Placebo14
Overall StudyNOT COMPLETED1 Multi-Dose Pregabalin0
Overall StudyNOT COMPLETED2 Single-dose Pregabalin2
Overall StudyNOT COMPLETED3 Placebo2

Adverse events3

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherPruritusSkin and subcutaneous tissue disorders1 Multi-Dose Pregabalin2162
otherPruritusSkin and subcutaneous tissue disorders2 Single-dose Pregabalin3163
otherPruritusSkin and subcutaneous tissue disorders3 Placebo7167

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortality1 Multi-Dose Pregabalin
Total, all-cause mortality2 Single-dose Pregabalin
Total, all-cause mortality3 Placebo
Total, other adverse events1 Multi-Dose Pregabalin216
Total, other adverse events2 Single-dose Pregabalin316
Total, other adverse events3 Placebo716
Total, serious adverse events1 Multi-Dose Pregabalin016
Total, serious adverse events2 Single-dose Pregabalin016
Total, serious adverse events3 Placebo016

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
22156332RESULT

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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