Detailed Pain Pattern After Laparoscopic Inguinal Hernia Repair

April 15, 2011 updated by: Zealand University Hospital

Early Pain Pattern and Its Components After Laparoscopic Inguinal Hernia Repair

Pain after laparoscopic groin hernia repair consist of different pain components (overall pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out which of these pain components that is most severe, so intervention can be targeted.

Study Overview

Status

Completed

Conditions

Detailed Description

Details about the components of early pain after laparoscopic groin hernia repair are lacking. A description of each component (overall pain, shoulder pain,incisional pain and visceral pain) is needed, so intervention against the different pain components can be targeted.

Patients fill out questionnaires about pain before operation and day 0-3 after operation.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Sealand
      • Koge, Sealand, Denmark, 4600
        • University Hospital Koge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Patients are consecutively included in this study. They are all undergoing elective laparoscopic groin hernia repair.

Description

Inclusion Criteria:

  • men
  • 18-69 years
  • uni- or bilateral hernia
  • ASA I-II
  • Danish speaking

Exclusion Criteria:

  • bad compliance
  • acute operation
  • daily intake of opioids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
lap. hernia repair
undergoing laparoscopic groin hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall pain during coughing (visual analog scale)
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
shoulder pain during coughing (visual analog scale and verbal rating scale)
Time Frame: 3 days
3 days
incisional pain during coughing (visual analog scale and verbal rating scale)
Time Frame: 3 days
3 days
visceral pain during coughing (visual analog scale and verbal rating scale)
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Mette A Tolver, M.D., Koge Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 16, 2010

Study Record Updates

Last Update Posted (Estimate)

April 18, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-125X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inguinal Hernia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe