Injury ArmCODLAMNCT03454789
Comparison of the Onset Times and Durations of Actions of Different Local Anesthetic Mixture Solutions [CODLAM]
A study testing brachial plexus block for LB Group, brachial plexus block for BS Group and brachial plexus block for LS Group in people with Injury Arm, run by University of Pecs.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 83 years
- Conditions the study is for
- Injury Arm
- What is being tested?
- brachial plexus block for LB Group, brachial plexus block for BS Group and brachial plexus block for LS Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective or emergency trauma surgery of hand or forearm
- consented to ultrasound-guided BPB
Who cannot join
- continuous peripheral nerve catheter technique or bilateral block was planned
- the patient refused to participate
- 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
- obstructive sleep apnea
- contraindications to PNB including local skin infections or allergy to LA agents.
About this study
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.
Read more
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).
Read the 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.
- Conditions
- Injury Arm
- Being tested
- brachial plexus block for LB Group, brachial plexus block for BS Group, brachial plexus block for LS Group, brachial plexus block for BL Group
- Keywords
- brachial plexus block, local anesthetic mixture solution, axillary-supraclavicular approach, outcome quality, lidocaine, bupivacaine, onset time, duration action local anesthetic, postoperative analgesia
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachial plexus block for LB GroupDrug
Also called 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
brachial plexus block for BS GroupDrug
Also called 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
brachial plexus block for LS GroupDrug
Also called 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
brachial plexus block for BL GroupDrug
Also called Bucain Actavis 5 mg/ml, Lidocain-Egis 1% 2:1
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
| Study group | Role | What they receive |
|---|---|---|
| LB Group | Active comparator | Ultrasound-guided brachial plexus block for LB Group (15 ml lidocaine 1% + 15 ml bupivacaine 0.5%) Receives: Drug: brachial plexus block for LB Group |
| BS Group | Active comparator | Ultrasound-guided brachial plexus block for BS Group (20 ml bupivacaine 0.5% + 10 ml normal saline) Receives: Drug: brachial plexus block for BS Group |
| LS Group | Active comparator | Ultrasound-guided brachial plexus block for LS Group (20 ml lidocaine 1% + 10 ml normal saline) Receives: Drug: brachial plexus block for LS Group |
| BL Group | Active comparator | and Ultrasound-guided brachial plexus block for BL Group (20 ml bupivacaine 0.5% + 10 ml lidocaine 1%) Receives: Drug: brachial plexus block for BL Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-30 minutes
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: 3-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start17 Jan 2017
- Primary completion15 Aug 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Pecs
- Responsible party
- Sponsor
- Investigators
- Lajos Bogar, Prof, Study director, Department of Anesth.and Int Care,University of Pecs, Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454789
- Sponsor's protocol ID
- 6940
- Acronym
- CODLAM
- Status last verified
- Mar 2018
- First submitted
- 16 Feb 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03454789
- Acronym / sponsor ID
- CODLAM / 6940
- Conditions
- Injury Arm
- Keywords
- brachial plexus block, local anesthetic mixture solution, axillary-supraclavicular approach, outcome quality, lidocaine, bupivacaine, onset time, duration action local anesthetic, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Collaborators
- Medical University of Pecs
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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%.
| Arm | Type | Receives |
|---|---|---|
| LB Group | Active comparator | Drug: brachial plexus block for LB GroupUltrasound-guided brachial plexus block for LB Group (15 ml lidocaine 1% + 15 ml bupivacaine 0.5%) |
| BS Group | Active comparator | Drug: brachial plexus block for BS GroupUltrasound-guided brachial plexus block for BS Group (20 ml bupivacaine 0.5% + 10 ml normal saline) |
| LS Group | Active comparator | Drug: brachial plexus block for LS GroupUltrasound-guided brachial plexus block for LS Group (20 ml lidocaine 1% + 10 ml normal saline) |
| BL Group | Active comparator | Drug: brachial plexus block for BL Groupand Ultrasound-guided brachial plexus block for BL Group (20 ml bupivacaine 0.5% + 10 ml lidocaine 1%) |
Who may qualify
- Ages
- 19 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective or emergency trauma surgery of hand or forearm
- consented to ultrasound-guided BPB
Key exclusion criteria (8 listed)
- continuous peripheral nerve catheter technique or bilateral block was planned
- the patient refused to participate
- psycho-mental conditions interfering with consent or assessment
- pre-existing chronic pain condition or daily analgesic or sedative consumption
- sedative or analgesic premedication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brachial plexus block for LB GroupAlso: Lidocain-Egis 1% Bucain Actavis 5 mg/ml,1:1Standardized 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 | Drug | LB Group |
| brachial plexus block for BS GroupAlso: Bucain Actavis 5 mg /mlStandardized 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 | Drug | BS Group |
| brachial plexus block for LS GroupAlso: 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 | Drug | LS Group |
| brachial plexus block for BL GroupAlso: Bucain Actavis 5 mg/ml, Lidocain-Egis 1% 2:1Standardized 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 | Drug | BL Group |
Primary outcome
onset time
Time frame: 0-30 minutes
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.
3 secondary outcomes
duration of action
Time frame: 1-22 hours
The outcome quality of BPB.
Time frame: 24-48 hours
Success rate of BPB.
Time frame: 3-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lajos Bogar, Prof study director
Department of Anesth.and Int Care,University of Pecs, Medical School
Questions about this trial
What is this clinical trial studying?
A study testing brachial plexus block for LB Group, brachial plexus block for BS Group and brachial plexus block for LS Group in people with Injury Arm, run by University of Pecs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset time (time frame: 0-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.