Laparoscopic Colonic SurgeryPhase 4NCT02219542
Cytokines of Patients With Transversus Abdominis Plane Block After Laparoscopic Colonic Surgery
A Phase 4 study testing transversus abdominis plane block in people with Laparoscopic Colonic Surgery, run by China Medical University, China at 1 site in China.
Trial summary
The investigators designed a study to determine whether with combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokines in patients undergoing Laparoscopic Colonic Surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Colonic Surgery
- What is being tested?
- transversus abdominis plane block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Feb 2015
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Participants were deemed eligible if they were candidates for spinal anesthesia undergoing Laparoscopic Colonic Surgery
Who cannot join
- •Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24 (of the 30 possible points)
- A history of neurological and psychiatric diseases including stroke, and psychosis
- Severe visual or hearing impairment
- Unwillingness to comply with the protocol or procedures
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Cytokines of Patients After Laparoscopic Colonic Surgery
The investigators designed a study to determine whether with combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokines in patients undergoing Laparoscopic Colonic Surgery.
Read the detailed description
The investigators designed a study to determine whether combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokine in patients undergoing Laparoscopic Colonic Surgery.
- Conditions
- Laparoscopic Colonic Surgery
- Being tested
- transversus abdominis plane block
- Keywords
- cytokine Transversus Abdominis Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversus abdominis plane blockDrug
transversus abdominis plane block with 20 mL saline
transversus abdominis plane blockDrug
transversus abdominis plane block with 20 mL 0.25% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| a standard general anesthesia | Placebo comparator | a standard general anesthesia and with transversus abdominis plane block 20 ml 0.9% sodium chloride Receives: Drug: transversus abdominis plane block |
| transversus abdominis plane block | Experimental | a standard general anesthesia with transversus abdominis plane block 20 mL 0.25% ropivacaine Receives: Drug: transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of cytokine level in plasma samples
The blood samples were collected before induction of anesthesia and at the end of surgery.
Measured: just after anesthesia induction ; at the end of the surgery; 24h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Colonic SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
- Investigators
- Hong Ma, M.D.,PhD, Study chair, The department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219542
- Sponsor's protocol ID
- 20140804
- Status last verified
- May 2014
- First submitted
- 14 Aug 2014
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokines of Patients After Laparoscopic Colonic Surgery
- ClinicalTrials.gov ID
- NCT02219542
- Acronym / sponsor ID
- 20140804
- Conditions
- Laparoscopic Colonic Surgery
- Keywords
- cytokine Transversus Abdominis Plane Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Aug 2014 (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 investigators designed a study to determine whether with combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokines in patients undergoing Laparoscopic Colonic Surgery.
Detailed description
The investigators designed a study to determine whether combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokine in patients undergoing Laparoscopic Colonic Surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a standard general anesthesia | Placebo comparator | Drug: transversus abdominis plane blocka standard general anesthesia and with transversus abdominis plane block 20 ml 0.9% sodium chloride |
| transversus abdominis plane block | Experimental | Drug: transversus abdominis plane blocka standard general anesthesia with transversus abdominis plane block 20 mL 0.25% ropivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Participants were deemed eligible if they were candidates for spinal anesthesia undergoing Laparoscopic Colonic Surgery
Key exclusion criteria (4 listed)
- •Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24 (of the 30 possible points)
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 |
|---|---|---|
| transversus abdominis plane blocktransversus abdominis plane block with 20 mL saline | Drug | a standard general anesthesia |
| transversus abdominis plane blocktransversus abdominis plane block with 20 mL 0.25% ropivacaine | Drug | transversus abdominis plane block |
Primary outcome
The change of cytokine level in plasma samples
Time frame: just after anesthesia induction ; at the end of the surgery; 24h after surgery
The blood samples were collected before induction of anesthesia and at the end of surgery.
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 1 Jul 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.
Hong Ma, M.D.,PhD study chair
The department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transversus abdominis plane block in people with Laparoscopic Colonic Surgery, run by China Medical University, China 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 1 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 1 Jul 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The change of cytokine level in plasma samples (time frame: just after anesthesia induction ; at the end of the surgery; 24h after 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 1 Jul 2015.