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Effect of Intraoperative Infiltration With Bupivacain on the Development of Chronic Pain After Inguinal Hernia Repair

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ClinicalTrials.gov Identifier: NCT00484731
Recruitment Status : Unknown
Verified May 2008 by Luzerner Kantonsspital.
Recruitment status was:  Recruiting
First Posted : June 11, 2007
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:

Study Description
Brief 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. The study is a randomized controlled triple blinded trial with a sequential study design.

Condition or disease Intervention/treatment Phase
Chronic Pain Procedure: Infiltration with Saline Procedure: Infiltration with Bupivacaine Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : July 2006
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Injection with Saline
Injection with Saline instead of Bupivacain
Procedure: Infiltration with Saline
Infiltration with Bupivacaine according to protocol
Active Comparator: Injection with Bupivacaine
Injection with Bupivacaine
Procedure: Infiltration with Bupivacaine


Outcome Measures

Primary Outcome Measures :
  1. occurrence of chronic pain [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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) [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484731


Contacts
Contact: Jürg Metzger, Prof. Dr. med. +41 41 205 48 60 juerg.metzger@luks.ch
Contact: Philipp Honigmann, Dr. med. +41 41 205 16 16 honeyman@bluewin.ch

Locations
Switzerland
Kantonsspital Luzern Recruiting
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Investigators
Principal Investigator: Jürg Metzger, Prof. Dr. med. Luzerner Kantonsspital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med. Philipp Honigmann, Kantonsspital Luzern
ClinicalTrials.gov Identifier: NCT00484731     History of Changes
Other Study ID Numbers: 585
ISRCTN pending
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: May 2008

Additional relevant MeSH terms:
Chronic Pain
Hernia, Inguinal
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents