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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Procedure: Infiltration with Saline; 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.

• Study Type: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Luzern, Switzerland, 6000
    • Kantonsspital Luzern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Infiltration with Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
occurrence of chronic pain	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Investigators: Principal Investigator: Jürg Metzger, Prof. Dr. med., Luzerner Kantonsspital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 7, 2007
• First Submitted That Met QC Criteria: June 8, 2007
• First Posted (Estimate): June 11, 2007

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 585; ISRCTN pending