Study Stopped
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Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2016
Longer than P75 for not_applicable postoperative-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 10, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedMarch 6, 2020
March 1, 2020
4 years
October 10, 2016
March 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Minutes under anesthesia
2 years
Secondary Outcomes (2)
Pain scores
2 years
Narcotic usage
2 years
Study Arms (3)
Local port site injection
NO INTERVENTIONUltrasound-guided nerve blocks
NO INTERVENTIONLaparoscopic guided nerve blocks
EXPERIMENTALThese patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy.
Interventions
It is common to use ultrasound to define the correct plane for abdominal wall nerve blocks, however, the utilization of laparoscopy to identify this plane is a new intervention that is previously undescribed in children.
Ropivacaine is a local anesthetic used to prevent pain during and after procedures. In this study, ropivacaine will be injected either directly at the port sites, or for a regional abdominal wall nerve block, either under ultrasound or laparoscopic guidance.
Eligibility Criteria
You may qualify if:
- Patients 5 - 17 years old.
- Patients undergoing laparoscopic procedures
- Patients that weigh greater than or equal to 34 kg and less than 100 kg.
You may not qualify if:
- Patients who underwent open surgical procedures will be excluded from this study.
- Patients that weigh less than 34kg.
- Patients that weigh more than 100 kg.
- Perforated appendicitis.
- Bowel obstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marcus Maleklead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 10, 2016
First Posted
October 26, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
March 6, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share