Clinical trial NCT01997593: Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected
Official title: Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Testicular
Colic
Keywords: analgesia
pediatric
pain
laparoscopy
ropivacaine
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.

Detailed description: 1. Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
2. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
3. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources .
4. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information .
5. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
6. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
7. Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
8. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan

Eligibility criteria: Inclusion Criteria:

1. Between 6 months and 5years.
2. Laparoscopic inguinal hernia repair
3. Laparoscopic testicular descent fixation

Exclusion Criteria:

1. Patient who are suffering from mental disease
2. Patient who suffering from neuromuscular disease
3. Local anesthetic allergy
4. Patient who needs directly into ICU after the operation.

Primary outcomes:
measure: pain score
timeFrame: within the first 2days after the surgery
Secondary outcomes:
measure: Analgesic dose
timeFrame: Within the first 2days after the surgery
measure: Gastrointestinal function recovery score
timeFrame: Within the first 2days after the surgery
measure: Wound score
timeFrame: Within the first 2days after the surgery
measure: Time to discharge
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: China Tongji Hospital
name: Yang Hui, Professor
role: STUDY_DIRECTOR
References: