Detailed Pain Pattern After Laparoscopic Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

Early Pain Pattern and Its Components After Laparoscopic Inguinal Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105039
• Other study ID #: SJ-125X
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: April 15, 2011
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2011
• Source: University Hospital Koge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Femoral Hernia
• Hernia
• Hernia, Femoral
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
Denmark	University Hospital Koge	Koge	Sealand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Koge

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall pain during coughing (visual analog scale)		3 days	No
Secondary	shoulder pain during coughing (visual analog scale and verbal rating scale)		3 days	No
Secondary	incisional pain during coughing (visual analog scale and verbal rating scale)		3 days	No
Secondary	visceral pain during coughing (visual analog scale and verbal rating scale)		3 days	No