Comparison of the Onset Times and Durations of Actions of Different Local Anesthetic Mixture Solutions [CODLAM]
Condition: Injury Arm
MeSH terms: Arm Injuries
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): brachial plexus block for LB Group; brachial plexus block for BS Group; brachial plexus block for LS Group; brachial plexus block for BL Group
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW; Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW; Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW; Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW
Other intervention name(s): Lidocain-Egis 1% Bucain Actavis 5 mg/ml,1:1; Bucain Actavis 5 mg /ml; Lidocain Egis 1%; Bucain Actavis 5 mg/ml, Lidocain-Egis 1% 2:1
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: LB= 15 ml lidocaine 1% + 15 ml bupivacaine 0.5%; BS= 20 ml bupivacaine 0.5% + 10 ml normal saline; LS=20 ml lidocaine 1% + 10 ml normal saline; and BL=20 ml bupivacaine 0.5% + 10 ml lidocaine 1%.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: brachial plexus block; local anesthetic mixture solution; axillary-supraclavicular approach; outcome quality; lidocaine, bupivacaine; onset time; duration action local anesthetic; postoperative analgesia