Clinical trial NCT04784104: Comparison of Infraclavicular And Supraclavicular Block
Official title: Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia Conduction
Upper Extremity Surgery
Pain, Postoperative
Anesthesia and Analgesia
Nerve Block
Brachial Plexus Block
Keywords: Brachial plexus block
Nerve block
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study covers 2 groups. Supraclavicular block will be applied to the first group and infraclavicular block will be applied to the second group.
Primary purpose: TREATMENT

Brief summary: Ultrasound-guided brachial plexus blocks are used successfully for upper extremity surgeries. In this randomized prospective single-blind study, ASA I-II patients aged 18-65 years undergoing hand, wrist, and forearm surgery will be randomly divided into two groups. First group will receive ultrasound-guided coronal oblique supraclavicular block using a 22G, 50 mm stimulator needle, and the second group, ultrasound-guided lateral sagittal infraclavicular block using a 22G 100 mm stimulator needle. We will prepare, 30 ml of 1:1 0.5% bupivacaine and 2% prilocaine with 5 mcg adrenaline per milliliter as local anesthetic mixture. Block application time, block success, sensory and motor block levels, and postoperative analgesia time will be recorded and compared between the groups. Accordingly, the success rate of the two methods will be evaluated.

Detailed description: In this prospective single-blind study, patients will be divided into 2 groups with the closed envelope method. Patients will be taken to the block application room before the operation. Standard monitoring (pulse oximetry, noninvasive blood pressure, ECG) will be applied to the patients. Premedication will be provided with 1mg IV midazolam after peripheral vascular access. Blocks will be performed by an experienced anesthesiologist under the guidance of USG and evaluated by another anesthesiologist who is blind to the block technique. After the antisepsis of the area, a 22G 100 mm stimulator needle will be used in the infraclavicular approach and a 22G 50 mm in the supraclavicular block. Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. 30 ml of 1:1 0.5% bupivacaine and 2% prilocaine plus 5 mcg adrenaline per ml will be used as local anesthetic mixture. The infraclavicular block will be applied by the lateral sagittal method under USG guidance. Supraclavicular block will be applied in the coronal oblique plane while the probe is placed on the clavicle. Following the blocks, the 5th, 10th, 15th, 20th, 25th, and 30th-minute sensory block levels, 10th, 20th, and 30th-minute motor block levels will be recorded. Sensory block level; Axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain). The motor block will be evaluated with a modified bromage scale: 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.

Block success; At the 30th minute of LA application, the pinprick test will define the presence of insensibility or only a sense of touch in the musculocutaneous, radial, ulnar, median, cutaneous antebrachii nerves. If any of these nerves are not blocked, it will be considered a failed block.

Postoperative analgesia time; It will be considered as when the NRS(Numeric Rating Scale) is≥1.

Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS scores at the 2nd, 6th, 12th, 24th hours.

Sensory (the time from local anesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time. Pain score during block application will be evaluated with the NRS. Block application time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn. Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves. Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate satisfaction, 3 = full satisfaction, after the procedure. Patients will be followed up for 24 hours in terms of undesirable side effects, vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and horner syndrome. As rescue anesthesia, sedoanalgesia will be tried with remifentanil infusion, if it is not successful, general anesthesia will be started with a laryngeal mask. As postoperative analgesic regimen, patients will receive 3 x 1000 mg IV acetaminophen. As rescue analgesia, Tramadol 1 mg/kg IV will be ordered to be administered when the patient's NRS is 3 or more. The first time when the patient receives rescue analgesia and the total dose of rescue analgesia for the first 24 hours will be recorded.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* ASA I-II
* Patients scheduled for hand, wrist, and forearm surgery

Exclusion Criteria:

* Uncoordinated patients
* Having a disease that prevents sensory block evaluation,
* Have coagulopathy,
* Known allergies to drugs to be used,
* Those with anatomical disorders at the application points
* Pregnant patients,
* Patients under 18 years of age,
* Patients with known local anesthetic allergy,
* Patients diagnosed with sepsis and bacteriemia,
* Skin infection at the injection site.

Primary outcomes:
measure: Block Formation Time
timeFrame: 30th minute pre-operatively
measure: Block Application Time
timeFrame: During Block Application
measure: Block success
timeFrame: At the 30th minute of LA application
measure: Sensory Block Level 5th minute
timeFrame: 5th minute
measure: Sensory Block Level 10th minute
timeFrame: 10th minute
measure: Sensory Block Level 15th minute
timeFrame: 15th minute
measure: Sensory Block Level 20th minute
timeFrame: 20th minute
measure: Sensory Block Level 25th minute
timeFrame: 25th minute
measure: Sensory Block Level 30th minute
timeFrame: 30th minute
Secondary outcomes:
measure: The Motor Block Level 10th minute
timeFrame: 10th minute
measure: Postoperative Analgesia Time
timeFrame: 24 hours post-operatively
measure: Pain Score Follow-up 2nd Hour
timeFrame: 2nd hour
measure: Block Return Time
timeFrame: 24 hours postoperatively
measure: Patient and Surgeon Satisfaction
timeFrame: Immediately after the surgery
measure: Undesirable Side Effects
timeFrame: 24 hours postoperatively
measure: The Rescue Analgesia
timeFrame: 24 hours postoperatively
measure: 24-Hour Total Opioid Consumption
timeFrame: 24 hours postoperatively
measure: Pain Score Follow-up 6th Hour
timeFrame: 6th Hour
measure: Pain Score Follow-up 12th Hour
timeFrame: 12th Hour
measure: Pain Score Follow-up 24th Hour
timeFrame: 24th Hour
measure: The Motor Block Level 20th minute
timeFrame: 20th minute
measure: The Motor Block Level 30th minute
timeFrame: 30th minute
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bozyaka Training and Research Hospital
state: Karabağlar
Study officials:
affiliation: Izmir Bozyaka Training and Research Hospital
name: Mehmet E Şen, MD
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Training and Research Hospital
name: Zeki T Tekgül, Assoc Prof
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Training and Research Hospital
name: Taşkın Altay, Assoc Prof
role: STUDY_CHAIR
References:
citation: Gurkan Y, Hosten T, Tekin M, Acar S, Solak M, Toker K. [Comparison of ultrasound-guided supraclavicular and infraclavicular approaches for brachial plexus blockade]. Agri. 2012;24(4):159-64. doi: 10.5505/agri.2012.38247. Turkish.
citation: Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
citation: Arcand G, Williams SR, Chouinard P, Boudreault D, Harris P, Ruel M, Girard F. Ultrasound-guided infraclavicular versus supraclavicular block. Anesth Analg. 2005 Sep;101(3):886-890. doi: 10.1213/01.ANE.0000159168.69934.CC.