Comparison · NCT02494336-sae
Trans-incisional Rectus Sheath Block vs Laparoscopic Guided Rectus Sheath 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
Cite this record
ConductScience Library. Trans-incisional Rectus Sheath Block vs Laparoscopic Guided Rectus Sheath Block: serious adverse events. Trial comparisons, record NCT02494336-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02494336-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 | 0.0833 | 0.0232 | 0.258 | wilson | |
| Risk in group 2 | 0.0417 | 0.00739 | 0.202 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0417 | -0.13 | 0.22 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.194 | 20.6 | log | |
| Odds ratio, group 1 over group 2 | 2.09 | 0.177 | 24.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Trans-incisional Rectus Sheath Block than on Laparoscopic Guided Rectus Sheath Block | 24 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Trans-incisional Rectus Sheath Block | rectus sheath block under direct visualization through the umbilical incision by the attending surgeon~Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms. | 2 | 24 | EG000 |
| Group 2 | Laparoscopic Guided Rectus Sheath Block | rectus sheath block under direct laparoscopic visualization by the attending surgeon~Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms. | 1 | 24 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 30 days
Source ClinicalTrials.gov
Trial
- Title
- Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy
- NCT number
- NCT02494336
- Phases
- NA
- Conditions
- Pain, Postoperative
- Interventions
- Trans-incisional rectus sheath block, Laparoscopic guided rectus sheath block, Ropivacaine
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Results first posted
- 2020-04-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02494336?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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