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 number | NCT00484731 |
| Secondary identifying numbers | 585 |
- 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
Scientific
Spitalstrasse
Luzern
6000
Switzerland
| juerg.metzger@ksl.ch |
Study information
| Study design | A randomized, placebo-controlled, triple-blinded and group sequential study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/07/2006 |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
6000
Switzerland
Sponsor information
Lucerne Cantonal Hospital (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Spitalstrasse
Luzern
6000
Switzerland
| Phone | +41 41 205 11 11 |
|---|---|
| info@ksl.ch | |
| Website | http://www.ksl.ch/GSD/KSL/Web/KSLwww.nsf/web/default |
"ROR" |
https://ror.org/02zk3am42 |
Funders
Funder type
Hospital/treatment centre
Lucerne Cantonal Hospital (Kantonsspital Luzern) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/11/2007 | 01/02/2019 | Yes | No |
| Results article | results | 01/01/2015 | 01/02/2019 | Yes | No |
Editorial Notes
01/02/2019: Publication reference added
