Contact information
Type
Scientific
Primary contact
Dr Jürg Metzger
ORCID ID
Contact details
Spitalstrasse
Luzern
6000
Switzerland
juerg.metzger@ksl.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00484731
Protocol/serial number
585
Study information
Scientific title
Acronym
Study hypothesis
We hypothesize that intra-operative infiltration with local anaesthesia (bupivacain) will lead to 50% reduction of the occurrence of chronic postoperative pain after inguinal hernia repair.
Ethics approval
Local Ethical Committee of the Canton Lucerne, approved on 1 May 2006, amended on 26 February 2007 (ref: 585)
Study design
A randomized, placebo-controlled, triple-blinded and group sequential study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Inguinal hernia
Intervention
Intervention group: Intraoperative injection of 20 ml bupivacain (0.25%) during inguinal hernia repair
Control group: Intraoperative injection of saline during inguinal hernia repair
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Occurrence of chronic pain (persistent pain at three-month follow-up measured by Visual Analogue Scale and Pain Matcher®) in the operated groin region.
Secondary outcome measures
The following will be measured at 1-, 3- and 12-month follow-up:
1. Level of pain: Pain Matcher®, VAS, areas of hyperalgesia, hypaesthesia
2. Hospitalization: Length of stay (days), American Society of Anesthesiologists (ASA) Classification, beginning of mobilisation (days)
3. Function: Return to work or normal activity (days and %), Quality of life (36-item Short Form health survey [SF-36])
Overall trial start date
01/07/2006
Overall trial end date
01/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. 18 years or older
2. Primary or recurrent single or double sided symptomatic but not incarcerated inguinal hernias with an elective hernia repair
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
264
Participant exclusion criteria
1. Patients with legal incompetence
2. Pregnant and nursing women
3. Presence or history of active malignancy or systemic diseases
4. Under immunosuppressive treatment
5. Systemic or severe local inflammation or infection
6. Wound healing disorders
7. Physical or mental incapacity, which makes it impossible to obtain informed consent
8. Patients with pacemakers or other implanted electrical devices (as pacemakers interfere with the electrical stimulation of the Pain Matcher® and vice versa)
9. Other types of hernia (e.g. umbilical hernia)
Recruitment start date
01/07/2006
Recruitment end date
01/08/2008
Locations
Countries of recruitment
Switzerland
Trial participating centre
Spitalstrasse
Luzern
6000
Switzerland
Sponsor information
Organisation
Lucerne Cantonal Hospital (Switzerland)
Sponsor details
Spitalstrasse
Luzern
6000
Switzerland
+41 41 205 11 11
info@ksl.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Lucerne Cantonal Hospital (Kantonsspital Luzern) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary