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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Injection with Saline

Injection with Saline instead of Bupivacain

Group Type PLACEBO_COMPARATOR

Infiltration with Saline

Intervention Type PROCEDURE

Infiltration with Bupivacaine according to protocol

Injection with Bupivacaine

Group Type ACTIVE_COMPARATOR

Infiltration with Bupivacaine

Intervention Type PROCEDURE

Interventions

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Infiltration with Saline

Infiltration with Bupivacaine according to protocol

Intervention Type PROCEDURE

Infiltration with Bupivacaine

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No