Comparison of Infraclavicular And Supraclavicular Block

Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Brachial Plexus Block; Anesthesia and Analgesia; Nerve Block; Anesthesia Conduction; Upper Extremity Surgery
• Intervention / Treatment: Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Prilocaine HCl 2% Injectable solution; Drug: Adrenaline amp. 0.5 mg; Procedure: Ultrasound guided supraclavicular block with coronal oblique method; Procedure: Ultrasound guided lateral sagittal infraclavicular block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mehmet E Şen, MD; Phone Number: +905436838272; Email: m_emre_sen@hotmail.com
• Study Contact Backup: Name: Zeki T Tekgül, Assoc Prof; Phone Number: +905058554705; Email: zekitekgul@yahoo.com

Study Locations

• Turkey
  • Karabağlar
    • Izmir, Karabağlar, Turkey, 35170
      • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supraclaviculer block; The coronal oblique supraclavicular block will be applied to the first group with ultrasound guidance using a 22G 50 mm stimulator needle. 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine, 2 ml saline with 5 mcg adrenaline per ml.) Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.	Drug: Bupivacaine HCl 0.5% Injectable Solution; 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.); Other Names: Bupivacaine 0.5%; Drug: Prilocaine HCl 2% Injectable solution; 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.); Other Names: Priloc %2; Drug: Adrenaline amp. 0.5 mg; 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.); Other Names: Adrenalin codex 0.5 mg 1 ml injectable solution; Procedure: Ultrasound guided supraclavicular block with coronal oblique method; The blocks will be performed by an experienced anesthesiologist with a USG guidence.
Experimental: Infraclaviculer block; The lateral sagittal infraclavicular block will be applied to the second group with ultrasound guidance using a 22G 100 mm stimulator needle. 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine, 2 ml saline with 5 mcg adrenaline per ml.). Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.	Drug: Bupivacaine HCl 0.5% Injectable Solution; 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.); Other Names: Bupivacaine 0.5%; Drug: Prilocaine HCl 2% Injectable solution; 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.); Other Names: Priloc %2; Drug: Adrenaline amp. 0.5 mg; 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.); Other Names: Adrenalin codex 0.5 mg 1 ml injectable solution; Procedure: Ultrasound guided lateral sagittal infraclavicular block; The blocks will be performed by an experienced anesthesiologist with USG guidence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block Formation Time	Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves.	30th minute pre-operatively
Block Application Time	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.	During Block Application
Block success	Block success; at the 30th minute of local anesthesic 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.	At the 30th minute of LA application
Sensory Block Level 5th minute	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).	5th minute
Sensory Block Level 10th minute	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).	10th minute
Sensory Block Level 15th minute	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).	15th minute
Sensory Block Level 20th minute	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).	20th minute
Sensory Block Level 25th minute	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).	25th minute
Sensory Block Level 30th minute	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).	30th minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Motor Block Level 10th minute	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. )	10th minute
Postoperative Analgesia Time	Postoperative analgesia time; It will be considered as when the NRS (Numeric Rating Scale) is≥1.	24 hours post-operatively
Pain Score Follow-up 2nd Hour	Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 2nd hour.	2nd hour
Block Return Time	Sensory (the time from local anaesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anaesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time.	24 hours postoperatively
Patient and Surgeon Satisfaction	Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate dissatisfaction, 3 = moderate satisfaction 4 =full satisfaction, after the procedure.	Immediately after the surgery
Undesirable Side Effects	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.	24 hours postoperatively
The Rescue Analgesia	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 will be recorded.	24 hours postoperatively
24-Hour Total Opioid Consumption	The total dose of rescue analgesia (Tramadol ) for the first 24 hours will be recorded.	24 hours postoperatively
Pain Score Follow-up 6th Hour	Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 6th hour.	6th Hour
Pain Score Follow-up 12th Hour	Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 12th hour.	12th Hour
Pain Score Follow-up 24th Hour	Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 24th hour.	24th Hour
The Motor Block Level 20th minute	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. )	20th minute
The Motor Block Level 30th minute	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. )	30th minute

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital
• Investigators: Study Chair: Mehmet E Şen, MD, Izmir Bozyaka Training and Research Hospital; Study Chair: Zeki T Tekgül, Assoc Prof, Izmir Bozyaka Training and Research Hospital; Study Chair: Taşkın Altay, Assoc Prof, Izmir Bozyaka Training and Research Hospital

Publications and helpful links

General Publications

• Gürkan Y, Hoşten 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 5, 2021
• Primary Completion (Anticipated): August 15, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Nerve block; Brachial plexus block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Pharmaceutical Solutions; Prilocaine; Bupivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: SupraInfraTez

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No