Shoulder PainNCT01095536
Risk Factors for Shoulder Pain and Emesis After Laparoscopic Cholecystectomy
An observational study of Shoulder Pain and Nausea, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Shoulder Pain, Nausea, Vomiting
- How many people
- 380 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective laparoscopic cholecystectomy
Who may be able to join
- > 21 years old,
- Chinese patient
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, Taiwan, 112
Chiu-Ming Ho, M.D., Ph.D, 886-2-28757549 ext. 350, cmho@vghtpe.gov.tw
About this study
Official title: The Observational Cohort Study to Identify Risk Factors for Shoulder Pain and Emesis After Laparoscopic Cholecystectomy Under General Anesthesia
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.
Read the 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.
- Conditions
- Shoulder Pain, Nausea, Vomiting
- Keywords
- laparoscopic cholecystectomy, elective, anesthesia, general, shoulder pain, nausea, vomiting, laparoscopic cholecystectomy, general anesthesia
- Medical subject headings
- Shoulder Pain, Nausea, Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative shoulder pain and emesis
Measured: within postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Investigators
- Chiu-Ming Ho, M.D., Ph.D., Principal investigator, Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095536
- Sponsor's protocol ID
- 201001019IC
- Status last verified
- Mar 2010
- First submitted
- 28 Mar 2010
- Last updated
- 6 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Observational Cohort Study to Identify Risk Factors for Shoulder Pain and Emesis After Laparoscopic Cholecystectomy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01095536
- Acronym / sponsor ID
- 201001019IC
- Conditions
- Shoulder Pain, Nausea, Vomiting
- Keywords
- laparoscopic cholecystectomy, elective, anesthesia, general, shoulder pain, nausea, vomiting, laparoscopic cholecystectomy, general anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective laparoscopic cholecystectomy
Key inclusion criteria (2 listed)
- > 21 years old,
- Chinese patient
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of postoperative shoulder pain and emesis
Time frame: within postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, Taiwan
Chiu-Ming Ho, M.D., Ph.D. principal investigator
Department of Anesthesiology, Taipei Veterans General Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Nausea, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative shoulder pain and emesis (time frame: within postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2010.