Gallbladder DiseasesNCT02827136
Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy
A study testing Lidocaine patch and hypafix and hypafix 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 lidocaine patch on the shoulder pain score after end of surgery. The secondary purpose of this study is to investigate the effect of lidocaine patch on the total number of analgesic request on ward. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Gallbladder Diseases
- What is being tested?
- Lidocaine patch and hypafix and hypafix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Feb 2017to 27 Sep 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic cholecystectomy under general anesthesia
Who cannot join
- Infection, trauma, or bleeding on shoulder
- Allergy to lidocaine
- Chronic pain
- Renal dysfunction
- Liver dysfunction
- Seizure
- History of shoulder surgery
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
Official title: Ajou University School of Medicine
The primary purpose of this study is to investigate the effect of lidocaine patch on the shoulder pain score after end of surgery.
The secondary purpose of this study is to investigate the effect of lidocaine patch on the total number of analgesic request on ward.
- Conditions
- Gallbladder Diseases
- Being tested
- Lidocaine patch and hypafix, hypafix
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patch and hypafixDrug
Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction
hypafixDrug
Appliance of hypafix on both shoulder tip after anesthetic induction
| Study group | Role | What they receive |
|---|---|---|
| Patch group | Experimental | Lidocaine patch and Hypafix Receives: Drug: Lidocaine patch and hypafix |
| Control group | Placebo comparator | Just Hypafix Receives: Drug: hypafix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain score
Measured: Change from baseline shoulder pain score up to 24 hr after end of surgery
Secondary outcomes (1)
Total number of analgesics request on ward
Measured: Up to postoperative day 3
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 start8 Feb 2017
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
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
- 63 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
- NCT02827136
- Sponsor's protocol ID
- AJIRB-MED-OBS-16-076
- Status last verified
- Dec 2017
- First submitted
- 4 Jul 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ajou University School of Medicine
- ClinicalTrials.gov ID
- NCT02827136
- Acronym / sponsor ID
- AJIRB-MED-OBS-16-076
- Conditions
- Gallbladder Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (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 lidocaine patch on the shoulder pain score after end of surgery.
The secondary purpose of this study is to investigate the effect of lidocaine patch on the total number of analgesic request on ward.
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 |
|---|---|---|
| Patch group | Experimental | Drug: Lidocaine patch and hypafixLidocaine patch and Hypafix |
| Control group | Placebo comparator | Drug: hypafixJust Hypafix |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Laparoscopic cholecystectomy under general anesthesia
Key exclusion criteria (7 listed)
- Infection, trauma, or bleeding on shoulder
- Allergy to lidocaine
- Chronic pain
- Renal dysfunction
- Liver dysfunction
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 |
|---|---|---|
| Lidocaine patch and hypafixAppliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction | Drug | Patch group |
| hypafixAppliance of hypafix on both shoulder tip after anesthetic induction | Drug | Control group |
Primary outcome
Shoulder pain score
Time frame: Change from baseline shoulder pain score up to 24 hr after end of surgery
1 secondary outcome
Total number of analgesics request on ward
Time frame: Up to postoperative day 3
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 19 Dec 2017.
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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 Lidocaine patch and hypafix and hypafix 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 7 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 19 Dec 2017. 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 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?
Shoulder pain score (time frame: Change from baseline shoulder pain score up to 24 hr after end of 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 19 Dec 2017.