Trial · NCT02494336
Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy
NCT02494336, Not applicable, Completed, Johns Hopkins All Children's Hospital; results first posted 2020-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy. Trials, record NCT02494336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02494336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy
- NCT number
- NCT02494336
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 48 participants, actual
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Conditions
- Pain, Postoperative
- Interventions
- Trans-incisional rectus sheath block, Laparoscopic guided rectus sheath block, Ropivacaine
- First posted
- 2015-07-10
- Last updated
- 2021-01-22
- Results first posted
- 2020-04-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post Operative Pain Rating | 5 days | Using the Wong-Baker FACES Pain Rating Scale (WBFPRS). The WBFPRS is a visual pain rating scale in which the participant looks at pictures of faces depicting levels of pain and chooses the one that most closely resembles their own pain. The scale ranges from 0 "no hurt" to 10 "Hurts Worst." |
| Secondary | Operative Time | 1 day | Operative time is measured as the time between X and Y. Reported in minutes. |
| Secondary | Use of Post-operative Intravenous/Oral Opioid and Non-opioid | 5 days | Amount of postoperative intravenous/oral opioid and non-opioid medications received by patient. This is being recorded as Morphine milligram equivalents (MME)/kilogram(kg) for days 1-5. |
| Secondary | Time to First Rescue Analgesic | 1 day | Amount of time in minutes until the first analgesic is given postoperatively. |
| Secondary | Number of Participants With Side Effects | 5 days | Number of participants with side effects such as nausea, vomiting, allergic reactions. |
| Secondary | Number of Participants With Complications | 30 days | Number of participants with complications such as infection, bleeding, intravascular injection, bowel puncture. |
| Secondary | Total Number of Complications | 30 days | Total number of complications such as infection, bleeding, intravascular injection, bowel puncture. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Post Operative Pain Rating | 5 days | score on a scale | MEAN | |
| SECONDARY | Operative Time | 1 day | minutes | MEAN | |
| SECONDARY | Use of Post-operative Intravenous/Oral Opioid and Non-opioid | 5 days | MME/kg | MEAN | |
| SECONDARY | Time to First Rescue Analgesic | 1 day | minutes | MEAN | |
| SECONDARY | Number of Participants With Side Effects | 5 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Complications | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Number of Complications | 30 days | complications | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Post Operative Pain Rating | Trans-incisional Rectus Sheath Block | 4.03 | Standard Deviation 1.46 | score on a scale | |
| Post Operative Pain Rating | Laparoscopic Guided Rectus Sheath Block | 4.03 | Standard Deviation 1.16 | score on a scale | |
| Operative Time | Trans-incisional Rectus Sheath Block | 62 | Standard Deviation 27 | minutes | |
| Operative Time | Laparoscopic Guided Rectus Sheath Block | 60 | Standard Deviation 19 | minutes | |
| Use of Post-operative Intravenous/Oral Opioid and Non-opioid | Trans-incisional Rectus Sheath Block | 0.49 | Standard Deviation 0.32 | MME/kg | |
| Use of Post-operative Intravenous/Oral Opioid and Non-opioid | Laparoscopic Guided Rectus Sheath Block | 056 | Standard Deviation .42 | MME/kg | |
| Time to First Rescue Analgesic | Trans-incisional Rectus Sheath Block | 14.4 | Standard Deviation 11.3 | minutes | |
| Time to First Rescue Analgesic | Laparoscopic Guided Rectus Sheath Block | 17.9 | Standard Deviation 16.8 | minutes | |
| Number of Participants With Side Effects | Trans-incisional Rectus Sheath Block | 0 | Participants | ||
| Number of Participants With Side Effects | Laparoscopic Guided Rectus Sheath Block | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trans-incisional Rectus Sheath Block | 24 | |
| Overall Study | STARTED | Laparoscopic Guided Rectus Sheath Block | 24 | |
| Overall Study | COMPLETED | Trans-incisional Rectus Sheath Block | 24 | |
| Overall Study | COMPLETED | Laparoscopic Guided Rectus Sheath Block | 24 | |
| Overall Study | NOT COMPLETED | Trans-incisional Rectus Sheath Block | 0 | |
| Overall Study | NOT COMPLETED | Laparoscopic Guided Rectus Sheath Block | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | readmission | Hepatobiliary disorders | Trans-incisional Rectus Sheath Block | 1 | 24 | 1 |
| serious | readmission | Hepatobiliary disorders | Laparoscopic Guided Rectus Sheath Block | 0 | 24 | 0 |
| serious | readmission | Renal and urinary disorders | Trans-incisional Rectus Sheath Block | 1 | 24 | 1 |
| serious | readmission | Renal and urinary disorders | Laparoscopic Guided Rectus Sheath Block | 0 | 24 | 0 |
| serious | Attempted suicide | Psychiatric disorders | Trans-incisional Rectus Sheath Block | 0 | 24 | 0 |
| serious | Attempted suicide | Psychiatric disorders | Laparoscopic Guided Rectus Sheath Block | 1 | 24 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trans-incisional Rectus Sheath Block | 0 | 24 |
| Total, all-cause mortality | Laparoscopic Guided Rectus Sheath Block | 0 | 24 |
| Total, other adverse events | Trans-incisional Rectus Sheath Block | 0 | 24 |
| Total, other adverse events | Laparoscopic Guided Rectus Sheath Block | 0 | 24 |
| Total, serious adverse events | Trans-incisional Rectus Sheath Block | 2 | 24 |
| Total, serious adverse events | Laparoscopic Guided Rectus Sheath Block | 1 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Trans-incisional Rectus Sheath Block vs Laparoscopic Guided Rectus Sheath Block: deaths from any cause | Trial comparisons |
| Trans-incisional Rectus Sheath Block vs Laparoscopic Guided Rectus Sheath Block: Number of Participants With Complications | Trial comparisons |
| Trans-incisional Rectus Sheath Block vs Laparoscopic Guided Rectus Sheath Block: Number of Participants With Side Effects | Trial comparisons |
| Trans-incisional Rectus Sheath Block vs Laparoscopic Guided Rectus Sheath Block: serious adverse events | Trial 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.
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/NCT02494336
GET https://conductscience.org/api/trials/v1/NCT02494336/registered