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

Chronic Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Infiltration with SalineInfiltration with Bupivacaine according to protocol

Procedure:Infiltration with Bupivacaine

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Injection with SalineInjection with Saline instead of Bupivacain

Injection with BupivacaineInjection with Bupivacaine

Study Status

Unknown status

Start Date: July 2006

Completed Date: June 2012

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: occurrence of chronic pain

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)

Study sponsors, principal investigator, and references

Principal Investigator: Jürg Metzger, Prof. Dr. med.

Lead Sponsor: Luzerner Kantonsspital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00484731

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