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

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Suspended

CT.gov ID

NCT01536717

Collaborator

(none)

Enrollment

Locations

Arms

129

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Diseases of Mitral Valve Aortic Valve Disorder Atrial Septal Defects Intracardiac Myxoma	Drug: Articaine hydrochloride 2% solution Drug: Sodium Chloride	Phase 4

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

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Periosteal and Subcutaneous Infusions of Articaine and Bupivacaine in Treatment of Acute Pain After Sternotomy

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bupivacaine hydrochloride 0.5% 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.	Drug: Articaine hydrochloride 2% solution 4 ml/h periosteal wound infusion duration of 72 h Other Names: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08
Placebo Comparator: Sodium chloride 0,9%	Drug: Sodium Chloride Placebo Sodium chloride 0,9%

Arm

Intervention/Treatment

Active Comparator: Bupivacaine hydrochloride 0.5%

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.

Drug: Articaine hydrochloride 2% solution

4 ml/h periosteal wound infusion duration of 72 h

Other Names:

Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08

Placebo Comparator: Sodium chloride 0,9%

Drug: Sodium Chloride

Placebo Sodium chloride 0,9%

Outcome Measures

Primary Outcome Measures

Oxycodone consumption [72 hours from initiation of treatment]

Secondary Outcome Measures

Intensity of pain in rest/in movement (AUC) [72 hours from initiation of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital	Helsinki	Uusimaa	Finland	00029
2	Department of Cardiothoracic surgery, Division of Surgery, Meilahti hospital, Helsinki University Central Hospital	Helsinki	Uusimaa	Finland	00029

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

Study Chair: Reino Pöyhiä, MD, PhD, Department of Anesthesiology and Intensive care, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Principal Investigator: Mihkel Meinberg, MD, Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital