Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

Phase 2

Completed

• Conditions: Testicular; Colic
• Interventions: Drug: intraperitoneal infiltration of ropivacaine

• Registration Number: NCT01997593
• Lead Sponsor: Ping Yang

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

Study Timeline

• Study First Submitted: 2013-10-27
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-28
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
pain score	within the first 2days after the surgery

Secondary Outcome Measures

Name	Time	Method
Time to discharge	Participants will be followed for the duration of hospital stay, an expected average of 2weeks
Gastrointestinal function recovery score	Within the first 2days after the surgery
Analgesic dose	Within the first 2days after the surgery
Wound score	Within the first 2days after the surgery

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China