Comparison · NCT01366196-sae
Pregabalin Group (P) vs Control Group (C): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Pregabalin Group (P) vs Control Group (C): serious adverse events. Trial comparisons, record NCT01366196-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01366196-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.082 | wilson | |
| Risk in group 2 | 0 | 0 | 0.082 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.082 | 0.082 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pregabalin Group (P) | Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.~Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.~All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.~On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.~Pregabalin 150 mg: Patients will receive two 75 mg capsules of pregabalin 1 hour before surgery. They continue to take 2 capsules of 75 mg (total 150 mg) until POD 14. | 0 | 43 | EG001 |
| Group 2 | Control Group (C) | Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.~Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.~All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.~On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.~Placebo: Patients will first receive two capsules of the placebo drug (with no active ingredients per dose) one hour before surgery. Patients will continue taking two capsules per day until POD 14. | 0 | 43 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
- NCT number
- NCT01366196
- Phases
- NA
- Conditions
- Lumbar Spinal Fusions
- Interventions
- Pregabalin 150 mg, Placebo
- Lead sponsor
- Hospital for Special Surgery, New York
- Results first posted
- 2017-06-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01366196?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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