Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

Colic Clinical Trial

Official title:

Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997593
• Other study ID #: 20130801
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2013
• Last updated: March 25, 2015
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Testicular

Intervention

Drug:
• intraperitoneal infiltration of ropivacaine
intraperitoneal infiltration of ropivacaine by a special equipment

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Ping Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score		within the first 2days after the surgery	No
Secondary	Analgesic dose		Within the first 2days after the surgery	No
Secondary	Gastrointestinal function recovery score		Within the first 2days after the surgery	No
Secondary	Wound score		Within the first 2days after the surgery	No
Secondary	Time to discharge		Participants will be followed for the duration of hospital stay, an expected average of 2weeks	No