Clinical Trials Logo

Clinical Trial Summary

To evaluate the success of surgical anesthesia of lateral and medial approaches of the costoclavicular block in patients undergoing upper extremity surgery.


Clinical Trial Description

Introduction:Upper limb surgeries are used on various pathology cases including tendon injuries, carpal tunnel syndrome, tenosynovitis, fractures secondary to trauma, contractures and vascular injuries. In many of such operations local anaesthesia becomes insufficient, and general or regional anaesthesia is required for comfort of the patient and the surgeon. Today, widespread use of nerve stimulators and ultrasound, the availability of post-operative pain management options, applicability of regional anaesthesia where there is risk of complications with general anaesthesia and its applicability along with general anaesthesia for pain management has made regional anaesthesia an attractive solution.The costoclavicular cavity lies in the depth and back of the median of clavicular. It connects to subclavius and clavicular terminus of pectoralis major muscle at the anterior and to the anterior chest wall at the posterior. The cavity is cranially continuous with the supraclavicular fossa and caudally continuous with the medial infraclavicular fossa above the upper border of the pectoralis minor muscle. Unlike the lateral infraclavicular fossa, the cords lie in the costoclavicular cavity in a relatively superficial form in a bundled triangular arrangement. Anatomical layout of cords in the costoclavicular cavity makes this an attractive area for ultrasound imaging and infraclavicular brachial plexus blockage. After placing the linear ultrasound probe on the midclavicular line and even in parallel to the clavicular, the three cords are imaged along with the axillary artery, whereupon local anaesthetic injection can be made with in-plane technique, directing the needle from lateral to medial. Medial approach to costoclavicular block defined by Nieuwveld involves placement of the linear ultrasound probe on the midclavicular line in parallel with the clavicular, as in the lateral approach, followed by imaging of the three cords alongside the axillary artery, whereupon the needle is directed from the medial to the lateral with the in-plane technique and applying local anaesthetic injection to the midpoint of three cords. The sample size calculation is done based on the time for establishing total anaesthesia and anaesthesia lead time variables in reference to the study conducted by Prangmalee Leurcharusmee et al. Calculating for 16±5 for lateral approach and 21±7 for medial approach, it is calculated that each group should include 44 patients at 80% power and 95% reliability rate for a meaningful difference at 5 minutes, requiring a total of 88 patients.After obtaining approval of the local ethics board, 88 patients who are considered for emergency or elective superior extremity surgery, in ASA I-IV group, in 18 to 75 age group, who do not have any known serious illness and who consent to participate will be included in the study. Material and Method:Patients in ASA IV group and above, patients taking anticoagulant/antiaggregate treatments, patients with nervous disorders, patients with infections or open wounds at the operation area and patients with allergies against any drug to be used in the study will be excluded from the study. Patients participating in the study will be randomly divided into 2 separate groups. These groups will be referred to as the Group M (Medial approach group) and Group L (Lateral approach group). Patients will be reviewed before being taken to operating room, they will be informed regarding the considered operation and their consent will be taken. Patients will be moved to regional anaesthesia room before the operation, where they will be equipped with fingertip oxygen saturation monitoring and 20-22 gauge intravenous channel. After confirming operation area sterilisation will be done with skin antiseptic, the operation area will be covered with sterilised cover and linear USG probe will be prepared in sterile conditions. All procedures will be implemented by an experienced anaesthesiologist. A blind researcher will review the patients and the surgical team will also be kept blind regarding the type of procedure. In Group M, after the patient will be taken to the regional anaesthesia room and preparations will be made, the blockage procedure will be applied by an anaesthesiologist who is not blind. The patient will be brought to supine position, the arm subject to procedure will be taken to 90° abduction with the palm looking at the ceiling. The Linear USG probe will be positioned on the midclavicular line and the chronometer will be started to record the scanning procedure time as the time elapsed until imaging of the axillary artery alongside with the three cords. After achieving optimum imaging skin infiltration will be applied with 1% lidocaine and an 80-100 mm needle will be directed from the medial to the lateral with the in-plane technique and the blockage procedure will be completed by injecting a combination of 10 cc 2% lidocaine and 10 cc 0.5% bupivacaine in the exact midpoint of the three cords. In Group L, again the patient will be taken to the regional anaesthesia room and preparations will be made, and the blockage procedure will be applied by an anaesthesiologist who is not blind. The patient will be brought to supine position, the arm subject to procedure will be taken to 90° abduction with the palm looking at the ceiling. The Linear USG probe will be positioned on the midclavicular line and the chronometer will be started to record the scanning procedure time as the time elapsed until imaging of the axillary artery alongside with the three cords. After achieving optimum imaging skin infiltration will be applied with 1% lidocaine and an 80-100 mm needle will be directed from the medial to the lateral with the in-plane technique and the blockage procedure will be completed by injecting a combination of 10 cc 2% lidocaine and 10 cc 0.5% bupivacaine in the exact midpoint of the three cords. The total procedure time, the complications arising during procedure, the local anaesthetic toxicity, the paraesthesia arising during the procedure, the distance between the needle tip and the pleura and the number of needle passes will be recorded for each procedure. A blind researcher will evaluate sensory blockage by checking radial, musculocutaneous, medial and ulnar nerve dermatomes with ice using triple point scale (0= no blockage, patient completely feels the cold; 1= analgesia, the patient does not feel the cold but feels the touch; 2= anaesthesia, the patient does not feel the touch) once per 5 minutes for 30/45 minutes taking the moment of needle removal as the 0 point. Motor block will also be evaluated by triple point scale (0=no blockage; 1=paraesthesia established; 2=paralysis established) once per 5 minutes for 30 minutes. Motor blockage at musculocutaneous, radial, median and ulnar nerves will be evaluated by elbow flexion, thumb abduction, thumb opposition and thumb adduction, in this order. Sensory and motor blockage starting time points and total anaesthesia establishment time points will be recorded. At 20/30 minutes point convex (M mode) USG probe will be used to evaluate diaphragmatic paralysis. Once surgical anaesthesia is established the operation will be started, the patient will be monitored throughout the operation, additional analgesia-sedation needs, returns to general anaesthesia and total surgery times will be recorded. After surgical operation is completed, patient and surgeon satisfaction will be questioned. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04757896
Study type Interventional
Source Ataturk University
Contact
Status Completed
Phase N/A
Start date December 25, 2020
Completion date April 28, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas