Evaluation of the Effectiveness of the Supraclavicular Block Associated With a Pecs Blocks I to Ensure Analgesia When Placing a Pacemaker
|ClinicalTrials.gov Identifier: NCT04067024|
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Pacemaker Ddd||Procedure: Local anesthesia made by surgeon Procedure: Regional anesthesia group||Not Applicable|
PECS 1 Block and Supraclavicular Nerve Block, were performed by an anesthesiologist under ultrasound control using a linear 8Mzt transducer, a Phillips HD 11 machine and a 50 mm needle Stimuplex 360 Braun. The ALR procedure was performed 30 minutes before the surgical incision. A volume of 15 ml of ropivacaine 3.75 mg/ml is used and distributed as follows: 12 ml for the Pecs 1 Block and 3 ml for the Supraclavicular nerve block: The patient was placed in supine position with the arm abducted at about 90 °, the puncture site being sterilized with betadine. The transducer was first placed in a subclavicular position in order to identify the major and minor pectoralis muscles, as well as the thoracoacromial artery, particularly the pectoral branch, additional color Doppler, was used for the identification of those vessels. The needle was directed in plane to the intermuscular space lying between the large and small pectoral, a careful avoidance of the thoracoacromial artery or its pectoral branch was ensured. The LA injection, under visual control of the spread between the two muscles, was initiated at the level of the 2nd and 3rd ribs after a classical aspiration test; 12 ml of the ropivacaine 0.375% were used. A spread of the LA appearing as an intermuscular hypoechoic "lens" was always searched.
Second, a supraclavicular nerve block was performed. We initially identified the C5 root and scanned cranially to visualize the superficial cervical plexus. then, moving caudally, the supraclavicular nerve was isolated appearing as a hypoechogenic structure between scalenus medius and posterior border of the sternocleidomastoid muscle. A total of 3 ml of ropivacaine 0,375% was deposited nearby this nerve.
In the ALC group (Anesthesia Local Surgeon's Anesthesia: Local Infiltration of N = 15 tissues) 15 ml Ropivacaine 3.75 mg/ml were injected in the subclavicular area, as usual, starting from the skin to the depth of the muscles.
In case of patient discomfort or failure of the techniques used, a further local infiltration consisting of a maximum of 10 ml lidocaine 2% performed as required by the surgeon was allowed as rescue. If this failed, the depth of sedation would gradually increase and ventilation would be controlled either by face or laryngeal mask Propofol 1-3 mg / Kg / IV + sufentanyl 2.5 μg / IV).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of the Effectiveness of the Supraclavicular Block Associated With a Pecs Blocks I to Ensure Analgesia When Placing a Pacemaker|
|Actual Study Start Date :||January 18, 2017|
|Actual Primary Completion Date :||July 7, 2017|
|Actual Study Completion Date :||July 7, 2017|
Active Comparator: Local anesthesia by the surgeon (LAS)
Local infiltration (ropivacaine 3,75 mg/ml) by surgeon
Procedure: Local anesthesia made by surgeon
infiltration with local anesthetics
Experimental: Regional anesthesia group (LRA):
By ultrasound, a pecs block I associated with a supraclavicular nerf block is performed. (Ropivacaine 3,75 mg/ml)
Procedure: Regional anesthesia group
Pecs block I and Supraclavicular nerf block
- Volume of local anesthetics used [ Time Frame: 24 hour ]ml
- Pain scoring [ Time Frame: 24 hours ]Visual analog scale
- Post-operative Paracetamol dose [ Time Frame: 24h ]paracetamol mg
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067024
|Brussels, Belgium, 1070|
|Principal Investigator:||wendy Fernandez, Dr.||Erasme Hospital,Route de lenniek 808, 1070, Brussels|