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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Luzerner Kantonsspital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT00484731
First received: June 7, 2007
Last updated: June 21, 2011
Last verified: May 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Luzerner Kantonsspital

Additional 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
Study First Received: June 7, 2007
Last Updated: June 21, 2011
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on September 16, 2014