Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

NCT ID: NCT01997593

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-06-30

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

Conditions

Testicular; Colic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ropivacaine

Preincisional wound intraperitoneal infiltration of 1% ropivacaine 0.3ml/kg was performed in group I patients before surgery.

Group Type: EXPERIMENTAL

intraperitoneal infiltration of ropivacaine

Intervention Type: DRUG

intraperitoneal infiltration of ropivacaine by a special equipment

Interventions

intraperitoneal infiltration of ropivacaine

intraperitoneal infiltration of ropivacaine by a special equipment

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ping Yang

OTHER

Sponsor Role: lead

Responsible Party

Ping Yang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yang Hui, Professor

Role: STUDY_DIRECTOR

China Tongji Hospital

Locations

Tongji Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

20130801

Identifier Type: -

Identifier Source: org_study_id