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This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups
Although ultrasound guided infraclavicular nerve block is routinely used to provide anesthesia for almost all of the upper extremity surgeries, optimal volume and concentration of locak anesthetic to be administered is still a subject of debate. This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomly allocated into three groups. 81 patients (27 in each group) are planned to be enrolled in this study due to a power analysis performed (G-power ver 3.1). Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups Researchers who perform the block and assess the block quality and onset will be blinded to patients' groups. Patients will also be blinded to groups they are assigned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concentrated | Active Comparator | Infraclavicular nerve block under guidance of ultrasonography will be performed using an undiluted solution of 45mg bupivacaine and 180mg prilocaine (bupivacaine 0.25% and prilocaine 1%, 18mL in total) to patients in this group |
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| Diluted by 33% | Active Comparator | Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 33% (bupivacaine 0.167% and prilocaine 0.66%, 27mL in total) to patients in this group |
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| Diluted by 50% | Active Comparator | Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 50% (bupivacaine 0.125% and prilocaine 0.5%, 36mL in total) to patients in this group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine 0.25% | Drug |
|
| |
| Prilocaine 1% |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory Block, as assessed by hollman scale for pinprick test | Sensorial response to pinprick will be assessed at innervation sites of ulnar median radial and musculocutaneous nerves. Innervation sites of assessment are volar skin of the fifth finger for ulnar nerve, volar skin of second finger for median nerve and dorsal, proximal of the second finger for radial nerve and skin of the anterolateral forearm for musculocutaneous nerve. | 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute |
| Motor Block, as assessed by hollman scale for motor blockade | Motor function for each nerve will be assessed. Movements to be evaluated are; abduction of the fingers for ulnar nerve, thumb opposition for median nerve, extension of the forearm for radial nerve and flexion of the forearm for musculocutaneous nerve. | 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute |
| Postoperative Sensory Block, as assessed by hollman scale for pinprick test | 1th hour in PACU | |
| Postoperative Motor Block, as assessed by hollman scale for motor blockadet | 1th hour in PACU |
| Measure | Description | Time Frame |
|---|---|---|
| Pain, as assessed by visual analogue scale | In addition, patients' first complaint time of pain will be recorded by nurse | 1st hour and 6th hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeki T Tekgul, MD | Izmir Bozyaka Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Bozyaka Training and Research Hospital | Izmir | İzmir | 35170 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26473102 | Background | Mosaffa F, Gharaei B, Qoreishi M, Razavi S, Safari F, Fathi M, Mohseni G, Elyasi H, Hosseini F. Do the Concentration and Volume of Local Anesthetics Affect the Onset and Success of Infraclavicular Anesthesia? Anesth Pain Med. 2015 Aug 22;5(4):e23963. doi: 10.5812/aapm.23963v2. eCollection 2015 Aug. | |
| 23518863 | Background |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D011318 | Prilocaine |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
|
|
| Infraclavicular Nerve Block | Procedure | Ultrasound guided infraclavicular nerve block |
|
| Bupivacaine 0.167% | Drug |
|
|
| Bupivacaine 0.125% | Drug |
|
|
| Prilocaine 0.66% | Drug |
|
|
| Prilocaine 0.5% | Drug |
|
|
| Ultrasound | Device | All nerve blocks will be performed with ultrasound guidance |
|
| Gonzalez AP, Bernucci F, Techasuk W, Pham K, Finlayson RJ, Tran DQ. A randomized comparison between 3 combinations of volume and concentration of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2013 May-Jun;38(3):206-11. doi: 10.1097/AAP.0b013e318287fe53. |
| 26423050 | Background | Fenten MG, Schoenmakers KP, Heesterbeek PJ, Scheffer GJ, Stienstra R. Effect of local anesthetic concentration, dose and volume on the duration of single-injection ultrasound-guided axillary brachial plexus block with mepivacaine: a randomized controlled trial. BMC Anesthesiol. 2015 Sep 30;15:130. doi: 10.1186/s12871-015-0110-0. |
| D000588 |
| Amines |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |