An interventional study of brachial plexus block for LB Group and brachial plexus block for BS Group in Injury Arm, sponsored by University of Pecs. Completed. Open to participants aged 19 Years to 83 Years. Per ClinicalTrials.gov, last updated 2018-03-13.
Sponsored by University of Pecs · Not applicable, Interventional, and Basic science
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.
63 studies on the registry are indexed under Arm Injuries; 10 are open to participants now.
This study's enrollment of 85 is above the median of 55 across 44 interventional studies indexed under Arm Injuries.
Browse Arm Injuries studies →University of Pecs is the lead sponsor of 106 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultrasound-guided brachial plexus block for LB Group (15 ml lidocaine 1% + 15 ml bupivacaine 0.5%)
Drug: brachial plexus block for LB Group
Ultrasound-guided brachial plexus block for BS Group (20 ml bupivacaine 0.5% + 10 ml normal saline)
Drug: brachial plexus block for BS Group
Ultrasound-guided brachial plexus block for LS Group (20 ml lidocaine 1% + 10 ml normal saline)
Drug: brachial plexus block for LS Group
and Ultrasound-guided brachial plexus block for BL Group (20 ml bupivacaine 0.5% + 10 ml lidocaine 1%)
Drug: brachial plexus block for BL Group
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
Also known as: Lidocain-Egis 1% Bucain Actavis 5 mg/ml,1:1
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
Also known as: Bucain Actavis 5 mg /ml
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
Also known as: Lidocain Egis 1%
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
Also known as: Bucain Actavis 5 mg/ml, Lidocain-Egis 1% 2:1
onset time
Complete sensory block was defined by loss of sensation of filament prick and touch on all four nerve distribution. Complete motor block was defined by the loss of thumb abduction, thumb adduction, thumb opposition, and flexion at elbow.
Time frame: 0-30 minutes
duration of action
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.
Time frame: 1-22 hours
The outcome quality of BPB.
The outcome quality 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).
Time frame: 24-48 hours
Success rate of BPB.
The rate of Excellent, Good, Tolerable and Failed in the four groups. 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.
Time frame: 3-14 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Aug 2017, 6 months.
Of 28 non-industry interventional studies with no phase under Arm Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 6 months is below that.
Counting every sponsor, half of 28 studies reached it within 24 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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