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Comparison · NCT04254081-sae

Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block vs 1% Lidocaine Paracervical Block: 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. Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block vs 1% Lidocaine Paracervical Block: serious adverse events. Trial comparisons, record NCT04254081-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04254081-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.00000000000000001390.121wilson
Risk in group 2000.117wilson
Risk difference, group 1 minus group 20-0.1170.121newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block
Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine~Buprenorphine 0.15 MG: Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
028EG000
Group 21% Lidocaine Paracervical Block
Paracervical block with 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate~Lidocaine 1% Injectable Solution: 20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
029EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion
NCT number
NCT04254081
Phases
PHASE4
Conditions
Procedural Pain, Buprenorphine, Adjuvants, Anesthesia, Dilation and Evacuation, Analgesics
Interventions
Buprenorphine 0.15 MG, Lidocaine 1% Injectable Solution
Lead sponsor
University of California, San Diego
Results first posted
2023-08-01

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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