NCT02827136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

July 4, 2016

Last Update Submit

December 18, 2017

Conditions

Gallbladder Diseases

Outcome Measures

Primary Outcomes (1)

  • Shoulder pain score

    Change from baseline shoulder pain score up to 24 hr after end of surgery

Secondary Outcomes (1)

  • Total number of analgesics request on ward

    Up to postoperative day 3

Study Arms (2)

Patch group

EXPERIMENTAL

Lidocaine patch and Hypafix

Drug: Lidocaine patch and hypafix

Control group

PLACEBO COMPARATOR

Just Hypafix

Drug: hypafix

Interventions

Lidocaine patch and hypafixDRUG

Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction

Patch group
hypafixDRUG

Appliance of hypafix on both shoulder tip after anesthetic induction

Control group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laparoscopic cholecystectomy under general anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, Seoum, South Korea

Location

MeSH Terms

Conditions

Gallbladder Diseases

Interventions

hypafix

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 11, 2016

Study Start

February 8, 2017

Primary Completion

September 27, 2017

Study Completion

September 27, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations

KR(1)