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Trial · NCT01366196

Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

NCT01366196, Not applicable, Completed, Hospital for Special Surgery, New York; results first posted 2017-06-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Pregabalin for the Treatment of Pain After Posterior Spinal Fusions. Trials, record NCT01366196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01366196

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
NCT number
NCT01366196
Status
Completed
Phases
Not applicable
Enrollment
86 participants, actual
Lead sponsor
Hospital for Special Surgery, New York
Conditions
Lumbar Spinal Fusions
Interventions
Pregabalin 150 mg, Placebo
First posted
2011-06-03
Last updated
2022-04-14
Results first posted
2017-06-21

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPatient Controlled Analgesia (PCA) Hydromorphone UsagePostoperative day 1
SecondaryOral Analgesic Supplementation UseDay of surgeryTabulate number of patients that used supplemental oral analgesics
OtherNumerical Pain Rating Scale Score on Day of SurgeryDay of SurgeryPain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
OtherNumerical Pain Rating Scale Score on Postoperative Day 1 at RestPostoperative Day 1 at restPain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
OtherNumerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1Postoperative Day 1 with Physical TherapyPain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.

Outcomes5

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPatient Controlled Analgesia (PCA) Hydromorphone UsagePostoperative day 1mLMEAN
SECONDARYOral Analgesic Supplementation UseDay of surgeryParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDNumerical Pain Rating Scale Score on Day of SurgeryDay of Surgeryunits on a scaleMEAN
OTHER_PRE_SPECIFIEDNumerical Pain Rating Scale Score on Postoperative Day 1 at RestPostoperative Day 1 at restunits on a scaleMEAN
OTHER_PRE_SPECIFIEDNumerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1Postoperative Day 1 with Physical Therapyunits on a scaleMEAN

Results by group10

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

OutcomeGroupCategoryValueSpreadUnits
Patient Controlled Analgesia (PCA) Hydromorphone UsageControl Group (C)44Standard Deviation 12mL
Patient Controlled Analgesia (PCA) Hydromorphone UsagePregabalin Group (P)39Standard Deviation 9mL
Oral Analgesic Supplementation UseControl Group (C)25Participants
Oral Analgesic Supplementation UsePregabalin Group (P)21Participants
Numerical Pain Rating Scale Score on Day of SurgeryControl Group (C)3.8Standard Deviation 2.6units on a scale
Numerical Pain Rating Scale Score on Day of SurgeryPregabalin Group (P)2.9Standard Deviation 2.2units on a scale
Numerical Pain Rating Scale Score on Postoperative Day 1 at RestControl Group (C)3.7Standard Deviation 2.1units on a scale
Numerical Pain Rating Scale Score on Postoperative Day 1 at RestPregabalin Group (P)3.3Standard Deviation 2.4units on a scale
Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1Control Group (C)4.3Standard Deviation 3.0units on a scale
Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1Pregabalin Group (P)4.5Standard Deviation 3.4units on a scale

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDControl Group (C)43
Overall StudySTARTEDPregabalin Group (P)43
Overall StudyCOMPLETEDControl Group (C)43
Overall StudyCOMPLETEDPregabalin Group (P)43
Overall StudyNOT COMPLETEDControl Group (C)0
Overall StudyNOT COMPLETEDPregabalin Group (P)0

Adverse events0

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

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityControl Group (C)
Total, all-cause mortalityPregabalin Group (P)
Total, other adverse eventsControl Group (C)043
Total, other adverse eventsPregabalin Group (P)043
Total, serious adverse eventsControl Group (C)043
Total, serious adverse eventsPregabalin Group (P)043

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
7177755BACKGROUNDPubMed
8657426BACKGROUNDPubMed
12467992BACKGROUNDPubMed
16223384BACKGROUNDPubMed
17177755BACKGROUNDPubMed
17513656BACKGROUNDPubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Pregabalin Group (P) vs Control Group (C): Oral Analgesic Supplementation UseTrial comparisons
Pregabalin Group (P) vs Control Group (C): serious adverse eventsTrial comparisons

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/NCT01366196

GET https://conductscience.org/api/trials/v1/NCT01366196/registered