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Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02827136
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ji Eun Kim, Ajou University School of Medicine

Brief 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.


Condition or disease Intervention/treatment Phase
Gallbladder Diseases Drug: Lidocaine patch and hypafix Drug: hypafix Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ajou University School of Medicine
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : September 27, 2017
Actual Study Completion Date : September 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patch group
Lidocaine patch and Hypafix
Drug: Lidocaine patch and hypafix
Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction

Placebo Comparator: Control group
Just Hypafix
Drug: hypafix
Appliance of hypafix on both shoulder tip after anesthetic induction




Primary Outcome Measures :
  1. Shoulder pain score [ Time Frame: Change from baseline shoulder pain score up to 24 hr after end of surgery ]

Secondary Outcome Measures :
  1. Total number of analgesics request on ward [ Time Frame: Up to postoperative day 3 ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

  • Infection, trauma, or bleeding on shoulder
  • Allergy to lidocaine
  • Chronic pain
  • Renal dysfunction
  • Liver dysfunction
  • Seizure
  • History of shoulder surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827136


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Seoum, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine

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Responsible Party: Ji Eun Kim, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02827136     History of Changes
Other Study ID Numbers: AJIRB-MED-OBS-16-076
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action