Condition category
Digestive System
Date applied
14/05/2007
Date assigned
16/07/2007
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ksl.ch/GSD/KSL/Web/KSLwww.nsf/web/default

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

Publication citations

Additional files

Editorial Notes