Acute PainPhase 4NCT04754451
The Effect of Lidocaine Patch for Postoperative Pain
A Phase 4 study testing Group L in people with Acute Pain, run by BON WOOK KOO at 1 site in South Korea.
Trial summary
The lidocaine patch is currently only permitted for post herpetic neuralgia but the investigators want to study its effectiveness in post operative pain after inguinal herniorrhaphy Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Group L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2021to 30 Nov 2022
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I - II
- Scheduled open unilateral herniorrhaphy
Who cannot join
- body mass index (BMI) < 18.5 or ≥ 35 kg/m2
- severe renal or hepatic dysfunction
- allergy to amide-based local anesthetic agents
- taking class 1 antiarrhythmic drugs (tocainide and mexiletine, etc.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Universuty, Bundang Hospital
Seongnam-si, Gyonggido
About this study
Official title: The Efficacy and Safety of 5% Lidocaine Patch for Postoperative Pain in Unilateral Inguinal Herniorrhaphy
The lidocaine patch is currently only permitted for post herpetic neuralgia but the investigators want to study its effectiveness in post operative pain after inguinal herniorrhaphy
Read the detailed description
After open unilateral inguinal herniorrhaphy, patients are randomly divided into group L and group P groups. Group L attaches two lidocaine patches for 12 hours, above and below the incision site. Group P attaches two placebo patches for 12 hours, above and below the incision site. Pain scores are recorded for 30 minutes, 2 hours, 24 hours, and 1 week after surgery.
- Conditions
- Acute Pain
- Being tested
- Group L
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group LDrug
Also called lidotopcaplasma
Attach two lidocaine patches for 12 hours, one above and below the incision site.
| Study group | Role | What they receive |
|---|---|---|
| Group P(placebo) | No intervention | Attach two placebo patches for 12 hours, above and below the incision site. |
| Group L(lidocaine patch) | Experimental | Attach two lidocaine patches for 12 hours, above and below the incision site. Receives: Drug: Group L |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain score
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Measured: 24 hours after the anesthesia finished.
Secondary outcomes (3)
The pain score
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Measured: 30 min after the anesthesia finished.
The pain score
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Measured: 2 hours after the anesthesia finished.
Total amount of cumulative analgesics
total amount of analgesics are measured for 24 hours after surgery.
Measured: 24 hours after the anesthesia finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Mar 2021
- Primary completion23 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies 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, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- BON WOOK KOO
- Sponsor type
- University, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Responsible party
- Sponsor-investigator, BON WOOK KOO, Seoul National University Bundang Hospital
- Investigators
- BON WOOK KOO, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754451
- Sponsor's protocol ID
- LDPS
- Status last verified
- Dec 2023
- First submitted
- 10 Feb 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahn HM, Oh HK, Kim DW, Kang SB, Koo BW, Lee PB. Efficacy and safety of 5% lidocaine patches for postoperative pain management in patients undergoing unilateral inguinal hernia repair: study protocol for a prospective, double-blind, randomized, controlled clinical trial. Trials. 2022 Sep 11;23(1):767. doi: 10.1186/s13063-022-06700-3.
PubMed 36089597
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of 5% Lidocaine Patch for Postoperative Pain in Unilateral Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT04754451
- Acronym / sponsor ID
- LDPS
- Conditions
- Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BON WOOK KOOUniversity, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- 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 lidocaine patch is currently only permitted for post herpetic neuralgia but the investigators want to study its effectiveness in post operative pain after inguinal herniorrhaphy
Detailed description
After open unilateral inguinal herniorrhaphy, patients are randomly divided into group L and group P groups. Group L attaches two lidocaine patches for 12 hours, above and below the incision site. Group P attaches two placebo patches for 12 hours, above and below the incision site. Pain scores are recorded for 30 minutes, 2 hours, 24 hours, and 1 week after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P(placebo) | No intervention | –Attach two placebo patches for 12 hours, above and below the incision site. |
| Group L(lidocaine patch) | Experimental | Drug: Group LAttach two lidocaine patches for 12 hours, above and below the incision site. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I - II
- Scheduled open unilateral herniorrhaphy
Key exclusion criteria (4 listed)
- body mass index (BMI) < 18.5 or ≥ 35 kg/m2
- severe renal or hepatic dysfunction
- allergy to amide-based local anesthetic agents
- taking class 1 antiarrhythmic drugs (tocainide and mexiletine, etc.)
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 |
|---|---|---|
| Group LAlso: lidotopcaplasmaAttach two lidocaine patches for 12 hours, one above and below the incision site. | Drug | Group L(lidocaine patch) |
Primary outcome
The pain score
Time frame: 24 hours after the anesthesia finished.
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
3 secondary outcomes
The pain score
Time frame: 30 min after the anesthesia finished.
The pain score
Time frame: 2 hours after the anesthesia finished.
Total amount of cumulative analgesics
Time frame: 24 hours after the anesthesia finished.
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 Dec 2023.
- Derived from this study: PubMed 36089597Ahn HM, Oh HK, Kim DW, Kang SB, Koo BW, Lee PB. Efficacy and safety of 5% lidocaine patches for postoperative pain management in patients undergoing unilateral inguinal hernia repair: study protocol for a prospective, double-blind, randomized, controlled clinical trial. Trials. 2022 Sep 11;23(1):767. doi: 10.1186/s13063-022-06700-3.
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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.
BON WOOK KOO principal investigator
Seoul National University Bundang Hospital
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 Group L in people with Acute Pain, run by BON WOOK KOO 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 2 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 Dec 2023. 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. 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 pain score (time frame: 24 hours after the anesthesia finished.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754451, which also lists 1 linked publication.
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 Dec 2023.