Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03454789
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2018-02-16
Brief Title:
Comparison of the Onset Times and Durations of Actions of Different Local Anesthetic Mixture Solutions CODLAM
Sponsor:
University of Pecs
Organization:
University of Pecs
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CODLAM
Brief 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 05 11 mixture Group LB n 17 or bupivacaine 033 Group BS n 14 or lidocaine 066 Group LS n 14 or bupivacaine 05 and lidocaine 1 21 mixture Group BL n 40 Total target volume of 04 mlkg 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 anxiolyticanalgesic consumption and the complications were recorded The quality of anesthesia was assessed by a sensory-motor-coping-pain scale 0-16
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 05 11 mixture Group LB n 17 or bupivacaine 033 Group BS n 14 or lidocaine 066 Group LS n 14 or bupivacaine 05 and lidocaine 1 21 mixture Group BL n 40 Total target volume of 04 mlkg 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 anxiolyticanalgesic 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 1701 and 1508 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 04 mlkg 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 507 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 11 mixture LB bupivacaine in normal saline BS lidocaine in normal saline LS and bupivacaine-lidocaine 21 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 P005 was considered significant
Priori power calculation was performed by GPower 3192 version effect size f04 alfa err005 power085 number of groups4 total sample size84
The study was conducted comparing the onset times and the duration of sensory effects of the same volumes of lidocaine-bupivacaine 11 mixture LB bupivacaine in normal saline BS lidocaine in normal saline LS and bupivacaine-lidocaine 21 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 P005 was considered significant
Priori power calculation was performed by GPower 3192 version effect size f04 alfa err005 power085 number of groups4 total sample size84
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None