Risk Factors for Shoulder Pain and Emesis After Laparosco... | NCT01095536

Studies
Risk Factors for Shoulder Pain and Emesis After Laparoscopic Cholecystectomy

NCT01095536

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Oct 6, 2010Estimated

Enrollment

380Estimated

Phase

Not provided

Conditions

Shoulder Pain
Nausea
Vomiting

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Feb 2011Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Mar 28, 2010

First Submission Date that Met QC Criteria

Mar 29, 2010

First Posted Date

Mar 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2010

Last Update Posted Date

Oct 6, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Risk factors for postoperative shoulder pain after laparoscopic cholecystectomy were not clear. Moreover, risk factors for postoperative emesis specially for this surgery were not detailed and accurate. The present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic cholecystectomy under general anesthesia.

Detailed Description

The present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic cholecystectomy under general anesthesia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

380Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of postoperative shoulder pain and emesis		within postoperative 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 21 years old,
Chinese patient

Exclusion Criteria:

current pregnancy,
patients with history of upper laparotomy,
inability to communicate before operation,
persistent emesis or shoulder pain before operation,
patients who converted to open cholecystectomy,
receiving postoperative ventilator support,
unstable postoperative condition or major complications.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients scheduled for elective laparoscopic cholecystectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chiu-Ming Ho, M.D., Ph.D.	Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Taipei Veterans General Hospital	Recruiting	Taipei	Taiwan	112	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D020069	Shoulder Pain
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D018771	Arthralgia
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided