Pain, Postoperative Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | September 1, 2021 |
Est. primary completion date | August 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Bozyaka Training and Research Hospital | Izmir | Karabaglar |
Lead Sponsor | Collaborator |
---|---|
Bozyaka Training and Research Hospital |
Turkey,
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):886-90, table of contents. — View 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. — View Citation
Gürkan 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Postoperative Analgesia Time | Postoperative analgesia time; It will be considered as when the NRS (Numeric Rating Scale) is=1. | 24 hours post-operatively | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 24-Hour Total Opioid Consumption | The total dose of rescue analgesia (Tramadol ) for the first 24 hours will be recorded. | 24 hours postoperatively | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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