Gallbladder DiseasesNCT02827097
The Effect of Rectus Sheath Block on the Postoperative Analgesia in the Patients Undergoing Robotic Single Port Cholecystectomy
A study testing denogan and rectus sheath block and denogan in people with Gallbladder Diseases, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The primary purpose of this study is to investigate the effect of rectus sheath block on abdominal pain score after robotic single port cholecystectomy. The secondary purpose of this study is to investigate the effect of rectus sheath block on fentanyl consumption during stay of recovery room after surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gallbladder Diseases
- What is being tested?
- denogan and rectus sheath block and denogan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Oct 2016
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- robotic single Port cholecystectomy for gallbladder disease
Who cannot join
- Allergy to ropivacaine, infection, history of abdominal surgery, body mass index more than 30
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Seoum
About this study
The primary purpose of this study is to investigate the effect of rectus sheath block on abdominal pain score after robotic single port cholecystectomy.
The secondary purpose of this study is to investigate the effect of rectus sheath block on fentanyl consumption during stay of recovery room after surgery.
- Conditions
- Gallbladder Diseases
- Being tested
- denogan and rectus sheath block, denogan
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denogan and rectus sheath blockDrug
administration of denogan and rectus sheath block with 0.375% ropivacaine
denoganDrug
administration of denogan
| Study group | Role | What they receive |
|---|---|---|
| Rectus sheath block group | Experimental | 1. administration of denogan
2. rectus sheath block with 0.375% ropivacaine Receives: Drug: denogan and rectus sheath block |
| Control group | Placebo comparator | just administration of denogan Receives: Drug: denogan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain score after surgery
Measured: Change from baseline abdominal pain score up to 24 hours
Secondary outcomes (1)
Fentanyl consumption in recovery room
Measured: Up to 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder DiseasesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Eun Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827097
- Sponsor's protocol ID
- AJIRB-MED-CT4-16-127
- Status last verified
- Jul 2019
- First submitted
- 4 Jul 2016
- Last updated
- 5 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rectus Sheath Block on the Postoperative Analgesia in the Patients Undergoing Robotic Single Port Cholecystectomy
- ClinicalTrials.gov ID
- NCT02827097
- Acronym / sponsor ID
- AJIRB-MED-CT4-16-127
- Conditions
- Gallbladder Diseases
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Jul 2016 (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 primary purpose of this study is to investigate the effect of rectus sheath block on abdominal pain score after robotic single port cholecystectomy.
The secondary purpose of this study is to investigate the effect of rectus sheath block on fentanyl consumption during stay of recovery room after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus sheath block group | Experimental | Drug: denogan and rectus sheath block1. administration of denogan 2. rectus sheath block with 0.375% ropivacaine |
| Control group | Placebo comparator | Drug: denoganjust administration of denogan |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- robotic single Port cholecystectomy for gallbladder disease
Key exclusion criteria (1 listed)
- Allergy to ropivacaine, infection, history of abdominal surgery, body mass index more than 30
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 |
|---|---|---|
| denogan and rectus sheath blockadministration of denogan and rectus sheath block with 0.375% ropivacaine | Drug | Rectus sheath block group |
| denoganadministration of denogan | Drug | Control group |
Primary outcome
Abdominal pain score after surgery
Time frame: Change from baseline abdominal pain score up to 24 hours
1 secondary outcome
Fentanyl consumption in recovery room
Time frame: Up to 1 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing denogan and rectus sheath block and denogan in people with Gallbladder Diseases, run by Ajou University School of Medicine at 1 site in South Korea.
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 1 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: withdrawn, as of the sponsor's last update on 5 Jul 2019. 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 South Korea. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Abdominal pain score after surgery (time frame: Change from baseline abdominal pain score up to 24 hours). 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 5 Jul 2019.