Back to resultsThe Effect of Lidocaine Patch for Postoperative Pain
Primary Purpose
Acute Pain
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Group L
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists physical status I - II
- Scheduled open unilateral herniorrhaphy
Exclusion Criteria:
- 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.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Group P(placebo)
Group L(lidocaine patch)
Arm Description
Attach two placebo patches for 12 hours, above and below the incision site.
Attach two lidocaine patches for 12 hours, above and below the incision site.
Outcomes
Primary Outcome Measures
The pain score
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Secondary Outcome Measures
The pain score
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
The pain score
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Total amount of cumulative analgesics
total amount of analgesics are measured for 24 hours after surgery.
Full Information
NCT ID
NCT04754451
First Posted
February 10, 2021
Last Updated
February 10, 2021
Sponsor
BON WOOK KOO
Collaborators
SK Chemicals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04754451
Brief Title
The Effect of Lidocaine Patch for Postoperative Pain
Official Title
The Efficacy and Safety of 5% Lidocaine Patch for Postoperative Pain in Unilateral Inguinal Herniorrhaphy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
BON WOOK KOO
Collaborators
SK Chemicals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The lidocaine patch is currently only permitted for postherpetic neuralgia but we want to investigate 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group P(placebo)
Arm Type
No Intervention
Arm Description
Attach two placebo patches for 12 hours, above and below the incision site.
Arm Title
Group L(lidocaine patch)
Arm Type
Experimental
Arm Description
Attach two lidocaine patches for 12 hours, above and below the incision site.
Intervention Type
Drug
Intervention Name(s)
Group L
Other Intervention Name(s)
lidotopcaplasma
Intervention Description
Attach two lidocaine patches for 12 hours, one above and below the incision site.
Primary Outcome Measure Information:
Title
The pain score
Description
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Time Frame
24 hours after the anesthesia finished.
Secondary Outcome Measure Information:
Title
The pain score
Description
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Time Frame
30 min after the anesthesia finished.
Title
The pain score
Description
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Time Frame
2 hours after the anesthesia finished.
Title
Total amount of cumulative analgesics
Description
total amount of analgesics are measured for 24 hours after surgery.
Time Frame
24 hours after the anesthesia finished.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists physical status I - II
Scheduled open unilateral herniorrhaphy
Exclusion Criteria:
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BON WOOK KOO
Phone
0317877499
Email
tendong2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BON WOOK KOO
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
36089597
Citation
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.
Results Reference
derived
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The Effect of Lidocaine Patch for Postoperative Pain
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