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Completed

NCT Number: NCT01997593

Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

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

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Key information

About this study

  • Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
  • Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
  • Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources .
  • Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information .
  • 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.
  • Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 6 months and 5years.
  • Laparoscopic inguinal hernia repair
  • Laparoscopic testicular descent fixation

Exclusion criteria

  • Patient who are suffering from mental disease
  • Patient who suffering from neuromuscular disease
  • Local anesthetic allergy
  • Patient who needs directly into ICU after the operation.

Treatment and study plan

intraperitoneal infiltration of ropivacaine

Drug

intraperitoneal infiltration of ropivacaine by a special equipment

Primary outcomes

  1. pain score

    Time frame: within the first 2days after the surgery

Secondary outcomes

  1. Analgesic dose

    Time frame: Within the first 2days after the surgery

  2. Gastrointestinal function recovery score

    Time frame: Within the first 2days after the surgery

  3. Wound score

    Time frame: Within the first 2days after the surgery

  4. Time to discharge

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2weeks

Sponsors and collaborators

Lead sponsor

Ping Yang

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 28, 2013
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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