Clinical trial NCT00484731: Effect of Intraoperative Infiltration With Bupivacain on the Development of Chronic Pain After Inguinal Hernia Repair
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2007-06-11
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: occurrence of chronic pain
timeFrame: 3 months
Secondary outcomes:
measure: 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)
timeFrame: one year
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
affiliation: Luzerner Kantonsspital
name: Jürg Metzger, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Honigmann P, Fischer H, Kurmann A, Audige L, Schupfer G, Metzger J. 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 [NCT00484731]. BMC Surg. 2007 Nov 6;7:22. doi: 10.1186/1471-2482-7-22.