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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484731
• Other study ID #: 585
• Secondary ID: ISRCTN pending
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: June 2012

Study information

• Verified date: February 2021
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Hernia, Inguinal

Intervention

Procedure:
• Infiltration with Saline
Infiltration with Bupivacaine according to protocol
• Infiltration with Bupivacaine

Locations

Country	Name	City	State
Switzerland	Kantonsspital Luzern	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of chronic pain		3 months
Secondary	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)		one year