Postoperative, PainPhase 4NCT01485939
Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy
A Phase 4 study testing 5% lidocaine patch in people with Postoperative, Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores after operation compared with placebo patch in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative, Pain
- What is being tested?
- 5% lidocaine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to May 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients of ASA Ⅰ-Ⅱ
- aged 18~65
- scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia.
Who cannot join
- patients with chronic pain
- patients with taking regular analgesics
- patients with allergy to ketorolac or lidocaine
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university Bundang hospital
Seongnam, Kyoung-ki-do, 463-707
Eunjoo Choi, MD, 82-31-787-6572, ejchoi7956@gmail.com
Pyung Bok Lee, MD, PhD
About this study
The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores after operation compared with placebo patch in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
- The 5% lidocaine patch have been approved for the treatment of postherpetic neuralgia.
- The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores, pain controlled drug(opioids, NSAID) in post operative period.
- Conditions
- Postoperative, Pain
- Being tested
- placebo patch applied, 5% lidocaine patch
- Keywords
- lidocaine patch, laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo patch appliedOther
Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.
5% lidocaine patchOther
Patients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| placebo patch | Placebo comparator | Not described Receives: Other: placebo patch applied |
| lidocaine patch | Active comparator | Not described Receives: Other: 5% lidocaine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain after laparoscopic cholecystectomy
We will measure intensity of pain(numeric rating scale)at post operative 30 minutes, 1, 2, 4, 6, 12, 24, 48 hours.
Measured: post operative periods
Secondary outcomes (1)
pain controlled drug doses in postoperative periods.
We will measure doses of pain controlled drug(opioid, NSAIDS) at post operative 30 minutes, 1, 2, 4, 6, 12, 24, 48 hours.
Measured: postoperative periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative, PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485939
- Sponsor's protocol ID
- Laparo_cholecystectomy_lidotop
- Status last verified
- Dec 2011
- First submitted
- 28 Nov 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01485939
- Acronym / sponsor ID
- Laparo_cholecystectomy_lidotop
- Conditions
- Postoperative, Pain
- Keywords
- lidocaine patch, laparoscopic cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 6 Dec 2011 (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 hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores after operation compared with placebo patch in patients undergoing laparoscopic cholecystectomy.
Detailed description
- The 5% lidocaine patch have been approved for the treatment of postherpetic neuralgia.
- The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores, pain controlled drug(opioids, NSAID) in post operative period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo patch | Placebo comparator | Other: placebo patch applied |
| lidocaine patch | Active comparator | Other: 5% lidocaine patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients of ASA Ⅰ-Ⅱ
- aged 18~65
- scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia.
Key exclusion criteria (3 listed)
- patients with chronic pain
- patients with taking regular analgesics
- patients with allergy to ketorolac or lidocaine
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 |
|---|---|---|
| placebo patch appliedPatients in this group would applied the placebo patch after laparoscopic cholecystectomy. | Other | placebo patch |
| 5% lidocaine patchPatients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy. | Other | lidocaine patch |
Primary outcome
post operative pain after laparoscopic cholecystectomy
Time frame: post operative periods
We will measure intensity of pain(numeric rating scale)at post operative 30 minutes, 1, 2, 4, 6, 12, 24, 48 hours.
1 secondary outcome
pain controlled drug doses in postoperative periods.
Time frame: postoperative periods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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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.
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 5% lidocaine patch in people with Postoperative, Pain, run by Seoul National University Hospital 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Dec 2011. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunjoo Choi, MD (82-31-787-6572, ejchoi7956@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain after laparoscopic cholecystectomy (time frame: post operative periods). 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 6 Dec 2011.