Detailed Pain Pattern After Laparoscopic Inguinal Hernia Repair

This study has been completed.
Sponsor:
Information provided by:
University Hospital Koge
ClinicalTrials.gov Identifier:
NCT01105039
First received: April 13, 2010
Last updated: April 15, 2011
Last verified: February 2011
  Purpose

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
Inguinal Hernia
Femoral Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Pain Pattern and Its Components After Laparoscopic Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by University Hospital Koge:

Primary Outcome Measures:
  • Overall pain during coughing (visual analog scale) [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • shoulder pain during coughing (visual analog scale and verbal rating scale) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • incisional pain during coughing (visual analog scale and verbal rating scale) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • visceral pain during coughing (visual analog scale and verbal rating scale) [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
lap. hernia repair
undergoing laparoscopic groin hernia repair

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105039

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

No publications provided

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
Study First Received: April 13, 2010
Last Updated: April 15, 2011
Health Authority: Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on October 29, 2014