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Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery

Primary Purpose

Diseases of Mitral Valve, Aortic Valve Disorder, Atrial Septal Defects

Status
Suspended
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Articaine hydrochloride 2% solution
Sodium Chloride
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diseases of Mitral Valve focused on measuring atrial septal defect, mitral valve annuloplasty, aortic valve annuloplasty, open heart surgery, oxycodone consumption, articain, bupivacaine, pain after sternotomy, postoperative pain, wound infusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective procedure
  • open heart surgery
  • aortic valve surgery
  • mitral valve surgery
  • atrial septal defect repair surgery
  • intracardial myxoma removal surgery

Exclusion Criteria:

  • local anesthetic allergy
  • sulphide allergy
  • asthma
  • pregnant women
  • neurological disease (TIA excluded)
  • congestive heart failure
  • left ventricle ejection fracture under 0.3
  • liver failure
  • diabetes mellitus with documented polyneuropathy
  • chronic pain condition
  • mother tongue not finnish or swedish
  • patients, who do not agree blood transfusions

Sites / Locations

  • Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital
  • Department of Cardiothoracic surgery, Division of Surgery, Meilahti hospital, Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine hydrochloride 0.5%

Sodium chloride 0,9%

Arm Description

Bupivacaine hydrochloride is related chemically and pharmacologically to the aminoacyl local anesthetics. Bupivacaine hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.

Outcomes

Primary Outcome Measures

Oxycodone consumption

Secondary Outcome Measures

Intensity of pain in rest/in movement (AUC)

Full Information

First Posted
February 16, 2012
Last Updated
May 3, 2019
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01536717
Brief Title
Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery
Official Title
Comparison of Periosteal and Subcutaneous Infusions of Articaine and Bupivacaine in Treatment of Acute Pain After Sternotomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Suspended
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine)
Detailed Description
Acute pain after open heart surgery can be moderate or strong and is mostly caused by sternotomy. Pain is the worst during the first two post-operative days and, if not adequately treated, can delay the patient´s recovery from surgery. Sternotomy pain can be alleviated by using paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. All these drugs may have remarkable side-effects which may delay the recovery from surgery: opioids are respiratory depressants and slower the gastrointestinal motility, NSAIDs reduce intrarenal blood flow and may disturb coagulation. Post-operative opioid consumption can be reduced by using wound infiltration analgesia. The use of wound infiltration analgesia has not been extensively investigated in treatment of acute pain after sternotomy. There is some evidence, that 0.5% bupivacaine reduces the acute post-sternotomy pain when infused constantly via catheters placed under the fascia (periosteal placement) and the skin. During 48 hours infusion toxic bupivacaine plasma levels were not observed. There is an evidence that local anesthetics can be bacteriostatic both in vitro and in vivo. Articaine is an amide-type local anesthetics, which has been used extensively in dental procedures since more than forty years. It has been successfully used in infiltration, epidural, spinal and other regional anesthesia procedures. Articaine is quickly hydrolyzed in plasma and excreted by kidneys. Clearance of articain (500-1110l/h) is faster than that of lidocaine (68l/h) and it is also the reason for articaine´s low toxicity profile. Because of it´s low toxicity and high ability to penetrate the periosteal tissue, articaine may be advantageous in treatment of acute pain after sternotomy, but aforementioned indication for use of articaine has not been investigated. Compared to other local anesthetics, articaine in high concentration has the same neurotoxicity profile, when injected directly into rat´s sciatic nerve. Articaine has not been extensively compared to other local anesthetics, but according the latest odontologic investigation, single dose 0.5% bupivacaine and single-dose 4% articaine were comparable in their analgesic effects during tooth extraction procedure. There are no controlled randomized trials comparing analgesic effect of articaine and other local anesthetics infusions. In our investigation bupivacain 0.5 % was chosen as an active control, because it has appeared effective in acute postoperative pain and it has reduced the need for opioid analgetics after sternotomy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diseases of Mitral Valve, Aortic Valve Disorder, Atrial Septal Defects, Intracardiac Myxoma
Keywords
atrial septal defect, mitral valve annuloplasty, aortic valve annuloplasty, open heart surgery, oxycodone consumption, articain, bupivacaine, pain after sternotomy, postoperative pain, wound infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine hydrochloride 0.5%
Arm Type
Active Comparator
Arm Description
Bupivacaine hydrochloride is related chemically and pharmacologically to the aminoacyl local anesthetics. Bupivacaine hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Arm Title
Sodium chloride 0,9%
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Articaine hydrochloride 2% solution
Other Intervention Name(s)
Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08
Intervention Description
4 ml/h periosteal wound infusion duration of 72 h
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride
Intervention Description
Placebo Sodium chloride 0,9%
Primary Outcome Measure Information:
Title
Oxycodone consumption
Time Frame
72 hours from initiation of treatment
Secondary Outcome Measure Information:
Title
Intensity of pain in rest/in movement (AUC)
Time Frame
72 hours from initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elective procedure open heart surgery aortic valve surgery mitral valve surgery atrial septal defect repair surgery intracardial myxoma removal surgery Exclusion Criteria: local anesthetic allergy sulphide allergy asthma pregnant women neurological disease (TIA excluded) congestive heart failure left ventricle ejection fracture under 0.3 liver failure diabetes mellitus with documented polyneuropathy chronic pain condition mother tongue not finnish or swedish patients, who do not agree blood transfusions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reino Pöyhiä, MD, PhD
Organizational Affiliation
Department of Anesthesiology and Intensive care, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mihkel Meinberg, MD
Organizational Affiliation
Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
Facility Name
Department of Cardiothoracic surgery, Division of Surgery, Meilahti hospital, Helsinki University Central Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

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Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery

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