Clinical trial NCT02820688: Concentration-Volume Relationship in Infraclavicular Block
Official title: Impact of Local Anesthetic Concentration-Volume Modifications on Ultrasound Guided Infraclavicular Nerve Block Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brachial Plexus Blockade
Keywords: Local Anesthtetics
Nerve Block
Bupivacaine
Prilocaine
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Scheduled for upper extremity surgery with infraclavicular nerve block

Exclusion Criteria:

* Patient Refusal
* Patients younger than 18
* Patients with known local anesthetic allergies
* Patients with a BMI\>30
* Diabetic Patients
* Uncooperated Patients
* Patients with coagulopathy or recieving anticoagulant therapy
* Skin infection on injection site
* Patients diagnosed with sepsis or bacteremia
* Physiologic and emotional lability
* Surgeries that are expected to last longer than 3 hours

Primary outcomes:
measure: Sensory Block, as assessed by hollman scale for pinprick test
timeFrame: 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute
measure: Motor Block, as assessed by hollman scale for motor blockade
timeFrame: 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute
measure: Postoperative Sensory Block, as assessed by hollman scale for pinprick test
timeFrame: 1th hour in PACU
measure: Postoperative Motor Block, as assessed by hollman scale for motor blockadet
timeFrame: 1th hour in PACU
Secondary outcomes:
measure: Pain, as assessed by visual analogue scale
timeFrame: 1st hour and 6th hour
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bozyaka Training and Research Hospital
Study officials:
affiliation: Izmir Bozyaka Training and Research Hospital
name: Zeki T Tekgul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.