Comparison of the Onset Times and Durations of Actions of Different Local Anesthetic Mixture Solutions [CODLAM]
NCT03454789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2018-03-13
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).
Conditions
- Injury Arm
Interventions
- DRUG
-
brachial plexus block for LB 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
- DRUG
-
brachial plexus block for BS 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
- DRUG
-
brachial plexus block for LS 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
- 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
Sponsors & Collaborators
-
Medical University of Pecs
collaborator OTHER -
University of Pecs
lead OTHER
Principal Investigators
-
Lajos Bogar, Prof · Department of Anesth.and Int Care,University of Pecs, Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 83 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-17
- Primary Completion
- 2017-08-15
- Completion
- 2017-11-30
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