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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Luzerner Kantonsspital.
Recruitment status was:  Recruiting
Information provided by:
Luzerner Kantonsspital Identifier:
First received: June 7, 2007
Last updated: June 21, 2011
Last verified: May 2008
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 Intervention Phase
Chronic Pain Procedure: Infiltration with Saline Procedure: Infiltration with Bupivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Luzerner Kantonsspital:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 404
Study Start Date: July 2006
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00484731

Contact: Jürg Metzger, Prof. Dr. med. +41 41 205 48 60
Contact: Philipp Honigmann, Dr. med. +41 41 205 16 16

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. med. Philipp Honigmann, Kantonsspital Luzern Identifier: NCT00484731     History of Changes
Other Study ID Numbers: 585
ISRCTN pending
Study First Received: June 7, 2007
Last Updated: June 21, 2011

Additional relevant MeSH terms:
Chronic Pain
Hernia, Inguinal
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hernia, Abdominal
Pathological Conditions, Anatomical
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on July 25, 2017