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Detailed Pain Pattern After Laparoscopic Inguinal Hernia Repair

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ClinicalTrials.gov Identifier: NCT01105039
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : April 18, 2011
Sponsor:
Information provided by:
Zealand University Hospital

Brief Summary:
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.

Condition or disease
Inguinal Hernia Femoral Hernia

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
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Pain Pattern and Its Components After Laparoscopic Inguinal Hernia Repair
Study Start Date : November 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Overall pain during coughing (visual analog scale) [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. shoulder pain during coughing (visual analog scale and verbal rating scale) [ Time Frame: 3 days ]
  2. incisional pain during coughing (visual analog scale and verbal rating scale) [ Time Frame: 3 days ]
  3. visceral pain during coughing (visual analog scale and verbal rating scale) [ Time Frame: 3 days ]


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients are consecutively included in this study. They are all undergoing elective laparoscopic groin hernia repair.
Criteria

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

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): NCT01105039


Locations
Denmark
University Hospital Koge
Koge, Sealand, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
Principal Investigator: Mette A Tolver, M.D. Koge Hospital

Responsible Party: Mette Astrup Tolver/MD., ph.d.-student, University Hospital Koge, gastroabdominal department
ClinicalTrials.gov Identifier: NCT01105039     History of Changes
Other Study ID Numbers: SJ-125X
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: February 2011

Keywords provided by Zealand University Hospital:
Pain pattern
overall pain
incisional pain
shoulder pain
visceral pain

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Femoral
Pathological Conditions, Anatomical
Hernia, Abdominal