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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484731
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
Luzerner Kantonsspital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain Hernia

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

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 ]

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00484731

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Kantonsspital Luzern
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
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Principal Investigator: Jürg Metzger, Prof. Dr. med. Luzerner Kantonsspital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Luzerner Kantonsspital Identifier: NCT00484731    
Other Study ID Numbers: 585
ISRCTN pending
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Chronic Pain
Hernia, Inguinal
Neurologic Manifestations
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents