The Effect of Lidocaine Patch for Postoperative Pain
The Efficacy and Safety of 5% Lidocaine Patch for Postoperative Pain in Unilateral Inguinal Herniorrhaphy
1 other identifier
interventional
32
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedDecember 26, 2023
December 1, 2023
1.7 years
February 10, 2021
December 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The pain score
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
24 hours after the anesthesia finished.
Secondary Outcomes (3)
The pain score
30 min after the anesthesia finished.
The pain score
2 hours after the anesthesia finished.
Total amount of cumulative analgesics
24 hours after the anesthesia finished.
Study Arms (2)
Group P(placebo)
NO INTERVENTIONAttach two placebo patches for 12 hours, above and below the incision site.
Group L(lidocaine patch)
EXPERIMENTALAttach two lidocaine patches for 12 hours, above and below the incision site.
Interventions
Attach two lidocaine patches for 12 hours, one above and below the incision site.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status I - II
- Scheduled open unilateral herniorrhaphy
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BON WOOK KOOlead
- SK Chemicals Co., Ltd.collaborator
Study Sites (1)
Seoul National Universuty, Bundang Hospital
Seongnam-si, Gyonggido, South Korea
Related Publications (1)
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.
PMID: 36089597DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BON WOOK KOO
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- associative professor of anesthesiology
Study Record Dates
First Submitted
February 10, 2021
First Posted
February 15, 2021
Study Start
March 15, 2021
Primary Completion
November 23, 2022
Study Completion
November 30, 2022
Last Updated
December 26, 2023
Record last verified: 2023-12