Investigating the effect of intra-operative infiltration with local anaesthesia on the development of chronic postoperative pain after inguinal hernia repair

ISRCTN	ISRCTN11190874
DOI	https://doi.org/10.1186/ISRCTN11190874
ClinicalTrials.gov (NCT)	NCT00484731
Protocol serial number	585
Sponsor	Lucerne Cantonal Hospital (Switzerland)
Funder	Lucerne Cantonal Hospital (Kantonsspital Luzern) (Switzerland)

Submission date: 14/05/2007
Registration date: 16/07/2007
Last edited: 01/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jürg Metzger
Scientific

Spitalstrasse
Luzern
6000
Switzerland

Email	juerg.metzger@ksl.ch

Study information

Primary study design	Interventional
Study design	A randomized, placebo-controlled, triple-blinded and group sequential study.
Secondary study design	Randomised controlled trial
Scientific title	Effect of intraoperative infiltration with local anaesthesia on the development of chronic pain after inguinal hernia repair: a randomized, triple-blinded, placebo-controlled trial.
Study objectives	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(s)	Local Ethical Committee of the Canton Lucerne, approved on 1 May 2006, amended on 26 February 2007 (ref: 585)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Occurrence of chronic pain (persistent pain at three-month follow-up measured by Visual Analogue Scale and Pain Matcher®) in the operated groin region.
Key secondary outcome measure(s)	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])
Completion date	01/08/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	264
Key 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
Key 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)
Date of first enrolment	01/07/2006
Date of final enrolment	01/08/2008

Locations

Countries of recruitment

Switzerland

Study participating centre

Spitalstrasse

Luzern
6000
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2015	01/02/2019	Yes	No
Protocol article	protocol	06/11/2007	01/02/2019	Yes	No

Editorial Notes

01/02/2019: Publication reference added