TesticularPhase 2NCT01997593
Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected
A Phase 2 study testing intraperitoneal infiltration of ropivacaine in people with Testicular and Colic, run by Ping Yang at 1 site in China.
Trial summary
The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Testicular, Colic
- What is being tested?
- intraperitoneal infiltration of ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 6 months and 5years.
- Laparoscopic inguinal hernia repair
- Laparoscopic testicular descent fixation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery
The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.
Read the detailed description
- 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
- Conditions
- Testicular, Colic
- Being tested
- intraperitoneal infiltration of ropivacaine
- Keywords
- analgesia, pediatric, pain, laparoscopy, ropivacaine
- Medical subject headings
- Colic, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraperitoneal infiltration of ropivacaineDrug
intraperitoneal infiltration of ropivacaine by a special equipment
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Experimental | Preincisional wound intraperitoneal infiltration of 1% ropivacaine 0.3ml/kg was performed in group I patients before surgery. Receives: Drug: intraperitoneal infiltration of ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Measured: within the first 2days after the surgery
Secondary outcomes (4)
Analgesic dose
Measured: Within the first 2days after the surgery
Gastrointestinal function recovery score
Measured: Within the first 2days after the surgery
Wound score
Measured: Within the first 2days after the surgery
Time to discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TesticularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ping Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ping Yang, Tongji Hospital
- Investigators
- Yang Hui, Professor, Study director, China Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997593
- Sponsor's protocol ID
- 20130801
- Status last verified
- Mar 2015
- First submitted
- 27 Oct 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01997593
- Acronym / sponsor ID
- 20130801
- Conditions
- Testicular, Colic
- Keywords
- analgesia, pediatric, pain, laparoscopy, ropivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ping YangUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.
Detailed description
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Experimental | Drug: intraperitoneal infiltration of ropivacainePreincisional wound intraperitoneal infiltration of 1% ropivacaine 0.3ml/kg was performed in group I patients before surgery. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 6 months and 5years.
- Laparoscopic inguinal hernia repair
- Laparoscopic testicular descent fixation
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraperitoneal infiltration of ropivacaineintraperitoneal infiltration of ropivacaine by a special equipment | Drug | ropivacaine |
Primary outcome
pain score
Time frame: within the first 2days after the surgery
4 secondary outcomes
Analgesic dose
Time frame: Within the first 2days after the surgery
Gastrointestinal function recovery score
Time frame: Within the first 2days after the surgery
Wound score
Time frame: Within the first 2days after the surgery
Time to discharge
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Hui, Professor study director
China Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intraperitoneal infiltration of ropivacaine in people with Testicular and Colic, run by Ping Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: within the first 2days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.