Chronic PainNCT00484731
Effect of Intraoperative Infiltration With Bupivacain on the Development of Chronic Pain After Inguinal Hernia Repair
A study testing Infiltration with Saline and Infiltration with Bupivacaine in people with Chronic Pain, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
The effect of intraoperative infiltration of the operation site with bupivacain on the development of chronic pain is the object of our trial. We hypothesize that the occurrence of chronic pain in the goup of patients receiving the infiltration will be 50% less than in the placebo group receiving normal saline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Infiltration with Saline and Infiltration with Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2006to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years) with primary or recurrent single or double sided symptomatic but not incarcerated inguinal hernias with an elective hernia repair are included.
- No other interventions (i.e. umbilical hernia) are allowed.
- Written informed consent needs to be obtained.
Who cannot join
- Patients with legal incompetence,
- Pregnant and nursing women,
- Patients with presence or history of active malignancy or systemic diseases,
- Under immunosuppressive treatment,
- With systemic or severe local inflammation or infection,
- With wound healing disorders and with physical or mental incapacity, which makes it impossible to obtain informed consent are excluded.
- As pacemakers interfere with the electrical stimulation of the Pain Matcher® and vice versa patients with pacemakers or other implanted electrical devices were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of Intra-operative Infiltration With Local Anaesthesia on the Development of Chronic Postoperative Pain After Inguinal Hernia Repair. A Randomized Placebo Controlled Triple Blinded and Group Sequential Study Design
The effect of intraoperative infiltration of the operation site with bupivacain on the development of chronic pain is the object of our trial. We hypothesize that the occurrence of chronic pain in the goup of patients receiving the infiltration will be 50% less than in the placebo group receiving normal saline. The study is a randomized controlled triple blinded trial with a sequential study design.
Read the detailed description
264 patients scheduled for an inguinal hernia repair using one of three procedures (Lichtenstein, Barwell and TEP = total extraperitoneal hernioplasty) are being randomly allocated intra-operatively into two groups. Group I patients receive a local injection of 20ml Carbostesin® 0.25% at the end of the operation according to a standardised procedure. Group II patients get a 20 ml placebo (0.9% Saline) injection. We use pre-filled identically looking syringes for blinded injection, i.e. the patient, the surgeon and the examinator who performs the postoperative clinical follow-ups remain unaware of group allocation. The primary outcome of the study is the occurrence of developing chronic pain (defined as persistent pain at 3 months FU) measured by VAS and Pain Matcher® device (Cefar Medical AB, Lund, Sweden).
In addition to a sample size re-evaluation three interim analyses are planned after 120, 180 and 240 patients had finished their 3-months follow-up to allow for early study termination.
- Conditions
- Chronic Pain
- Being tested
- Infiltration with Saline, Infiltration with Bupivacaine
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltration with SalineProcedure or surgery
Infiltration with Bupivacaine according to protocol
Infiltration with BupivacaineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Injection with Saline | Placebo comparator | Injection with Saline instead of Bupivacain Receives: Procedure: Infiltration with Saline |
| Injection with Bupivacaine | Active comparator | Injection with Bupivacaine Receives: Procedure: Infiltration with Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of chronic pain
Measured: 3 months
Secondary outcomes (1)
Level of Pain:Pain Matcher®,VAS;Areas of hyperalgesia,hypaesthesia Hospitalization:Length of stay (days) ASA-Classification Beginning of mobilisation (days) Return to work or normal activity (days and %) Quality of life (SF36)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startJul 2006
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jürg Metzger, Prof. Dr. med., Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484731
- Sponsor's protocol ID
- 585
- Other IDs
- ISRCTN pending
- Status last verified
- Feb 2021
- First submitted
- 7 Jun 2007
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Honigmann P, Fischer H, Kurmann A, Audige L, Schupfer G, Metzger J. Investigating the effect of intra-operative infiltration with local anaesthesia on the development of chronic postoperative pain after inguinal hernia repair. A randomized placebo controlled triple blinded and group sequential study design [NCT00484731]. BMC Surg. 2007 Nov 6;7:22. doi: 10.1186/1471-2482-7-22.
PubMed 17986324
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Intra-operative Infiltration With Local Anaesthesia on the Development of Chronic Postoperative Pain After Inguinal Hernia Repair. A Randomized Placebo Controlled Triple Blinded and Group Sequential Study Design
- ClinicalTrials.gov ID
- NCT00484731
- Acronym / sponsor ID
- 585
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of intraoperative infiltration of the operation site with bupivacain on the development of chronic pain is the object of our trial. We hypothesize that the occurrence of chronic pain in the goup of patients receiving the infiltration will be 50% less than in the placebo group receiving normal saline. The study is a randomized controlled triple blinded trial with a sequential study design.
Detailed description
264 patients scheduled for an inguinal hernia repair using one of three procedures (Lichtenstein, Barwell and TEP = total extraperitoneal hernioplasty) are being randomly allocated intra-operatively into two groups. Group I patients receive a local injection of 20ml Carbostesin® 0.25% at the end of the operation according to a standardised procedure. Group II patients get a 20 ml placebo (0.9% Saline) injection. We use pre-filled identically looking syringes for blinded injection, i.e. the patient, the surgeon and the examinator who performs the postoperative clinical follow-ups remain unaware of group allocation. The primary outcome of the study is the occurrence of developing chronic pain (defined as persistent pain at 3 months FU) measured by VAS and Pain Matcher® device (Cefar Medical AB, Lund, Sweden).
In addition to a sample size re-evaluation three interim analyses are planned after 120, 180 and 240 patients had finished their 3-months follow-up to allow for early study termination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection with Saline | Placebo comparator | Procedure: Infiltration with SalineInjection with Saline instead of Bupivacain |
| Injection with Bupivacaine | Active comparator | Procedure: Infiltration with BupivacaineInjection with Bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥ 18 years) with primary or recurrent single or double sided symptomatic but not incarcerated inguinal hernias with an elective hernia repair are included.
- No other interventions (i.e. umbilical hernia) are allowed.
- Written informed consent needs to be obtained.
Key exclusion criteria (7 listed)
- Patients with legal incompetence,
- Pregnant and nursing women,
- Patients with presence or history of active malignancy or systemic diseases,
- Under immunosuppressive treatment,
- With systemic or severe local inflammation or infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infiltration with SalineInfiltration with Bupivacaine according to protocol | Procedure or surgery | Injection with Saline |
| Infiltration with Bupivacaine | Procedure or surgery | Injection with Bupivacaine |
Primary outcome
occurrence of chronic pain
Time frame: 3 months
1 secondary outcome
Level of Pain:Pain Matcher®,VAS;Areas of hyperalgesia,hypaesthesia Hospitalization:Length of stay (days) ASA-Classification Beginning of mobilisation (days) Return to work or normal activity (days and %) Quality of life (SF36)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 17986324Honigmann P, Fischer H, Kurmann A, Audige L, Schupfer G, Metzger J. Investigating the effect of intra-operative infiltration with local anaesthesia on the development of chronic postoperative pain after inguinal hernia repair. A randomized placebo controlled triple blinded and group sequential study design [NCT00484731]. BMC Surg. 2007 Nov 6;7:22. doi: 10.1186/1471-2482-7-22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürg Metzger, Prof. Dr. med. principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration with Saline and Infiltration with Bupivacaine in people with Chronic Pain, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of chronic pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.