NCT00484731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

5.4 years

First QC Date

June 7, 2007

Last Update Submit

February 17, 2021

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • occurrence of chronic pain

    3 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

Injection with Saline

PLACEBO COMPARATOR

Injection with Saline instead of Bupivacain

Procedure: Infiltration with Saline

Injection with Bupivacaine

ACTIVE COMPARATOR

Injection with Bupivacaine

Procedure: Infiltration with Bupivacaine

Interventions

Infiltration with SalinePROCEDURE

Infiltration with Bupivacaine according to protocol

Injection with Saline
Infiltration with BupivacainePROCEDURE
Injection with Bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 17986324DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Sodium ChlorideBupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jürg Metzger, Prof. Dr. med.

    Luzerner Kantonsspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 11, 2007

Study Start

July 1, 2006

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

CH(1)