Injury Arm Clinical Trial
Official title:
Comparison of the Onset Times and Durations of Actions of Different Local Anesthetic Mixture Solutions Used for Ultrasound-guided Axillary-supraclavicular Brachial Plexus Blocks for Upper Limb Trauma Surgery
Objective To investigate the onset times and duration of local anesthetic mixture solutions
used for axillary-supraclavicular brachial plexus blocks and to compare the quality of
anesthesia in patients with trauma of the upper limb.
Design Randomized-prospective, observational study. Setting Perioperative, Trauma Clinic,
University of Pecs, Hungary. Participants 85 consecutive, unpremedicated ASA physical status
I-III patients, between the ages of 19 and 83, scheduled for trauma surgery of the hand and
forearm.
Interventions Patients assigned to four groups for standardized ultrasound guided
axillary-supraclavicular block with lidocaine 1% and bupivacaine 0,5% 1:1 mixture (Group LB,
n = 17) or bupivacaine 0.33% (Group BS, n = 14) or lidocaine 0,66% (Group LS, n = 14) or
bupivacaine 0.5% and lidocaine 1% 2:1 mixture (Group BL, n = 40). Total target volume of 0.4
ml/kg was administered to both groups.
Measurements Data were collected on patient demographics, the onset times and the duration of
actions of local anesthetic mixtures were measured, the tourniquet discomfort, vital
parameters, pre and postoperative verbal numeric rating scale of pain intensity,
anxiolytic/analgesic consumption and the complications were recorded. The quality of
anesthesia was assessed by a sensory-motor-coping-pain scale (0-16).
Total of 93 American Society of Anesthesiologist (ASA) I-III consecutive adult patients aged
between 19 and 83 years old scheduled for elective or emergency trauma surgery of hand and
forearm under ultrasound-guided brachial plexus block (UG BPB) between 17.01. and 15.08. in
2017 were assigned to this randomized-prospective observational study after approval by the
University Research Ethics Board. Patients were excluded if continuous peripheral nerve
catheter technique or bilateral block was planned, or the patient refused to participate.
Exclusion criteria included psycho-mental conditions interfering with consent or assessment;
pre-existing chronic pain condition or daily analgesic or sedative consumption; sedative or
analgesic premedication; pre-existing neurological disorders affecting the brachial plexus
(BP); obstructive sleep apnea; contraindications to BPB including local skin infections or
allergy to local anesthetic (LA) agents. After exclusion, eligible patients for the study
were randomized to four LA mixture solution groups and analyzed and presented in a
Consolidated Standards of Reporting Trials flow diagram. Standardized UG
axillary-supraclavicular (AX-SC) approach to the BP was performed under sterile conditions by
the same anesthesiologist. The standardized dose was 0.4 ml/kg, the targeted maximized single
shot volume was 30 ml. After administration of LA, standard anesthesia monitoring was started
in the operating room. Data were collected as baseline (T0); intraoperative mean values
(Top); postoperative values straight after surgery (Tpop); 6 and 24 after surgery (T6; T24)
including measurement of heart rate (HR), non-invasive arterial blood pressure (NIBP), and
verbal numeric rate (VNR, 11 point scale) of pain intensity. The extent of sensory and motor
blockade was assessed meticulously in the corresponding region after the total dose of LA was
injected until the blockade was defined as completed. Sensory block was tested by pinching
and touching the skin of the arm and hand at the areas innervated by the four nerves. A von
Frey filament with a standard target force of 10 gr (Touch Test ® Sensory Evaluator, Red
5,07; USA) was used for the assessment of the loss of protective sensation. The outcome
quality and success rate of BPB was assessed by a composite tool designed for evaluating the
loss of sensory (S, 0-4: failed to excellent), motor function (M, 0-4: failed to excellent),
the coping of the patient (C, 0-4: failed to excellent) and the postoperative pain at the end
of surgery and 24 h after (P, 0-4: pain before the end of surgery to long-lasting - 24 h -
analgesia). The overall quality of PNB was evaluated by independent examiners, based on the
aggregate 0-16 point scale. Under 7 Point the block was defined as failed, 8-11 = Tolerable;
12-13 = Good; 14-16 = Excellent. The duration of anesthesia was defined as the time between
the end of the LA injection for BPB and the return of the sensory function reported by the
patient or the necessity for first analgesic medication.
The study was conducted comparing the onset times and the duration of sensory effects of the
same volumes of lidocaine-bupivacaine 1:1 mixture (LB), bupivacaine in normal saline (BS),
lidocaine in normal saline (LS), and bupivacaine-lidocaine 2:1 mixture (BL) for BPB.
Midazolam and fentanyl consumption were analyzed in the four groups, the outcome quality of
blocks, vital parameters, visual numeric rate (VNR) of pain intensity values and non-steroid
analgesic consumptions were compared between the four groups.
The IBM SPSS Statistics (Windows, version 24, 2016) was used in our analyses. Paired samples
t-test, Kruskal-Wallis test combined with the Mann-Whitney U test for post hoc testing were
used in analyzing the ordinal data. The Chi-square test was used for comparison of the
categorical variables between the groups. ANOVA combined with Bonferroni post hoc test was
used in analyzing the variance of linear data between groups. P<0.05 was considered
significant.
Priori power calculation was performed by GPower 3.1.9.2 version: effect size f=0.4, alfa
err=0.05; power=0.85; number of groups=4; total sample size=84.
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