MEV90ROPI: MEV 90 of 0.5% Ropivacaine In Infraclavicular Blocks
Study Details
Study Description
Brief Summary
Nerve blocks are routinely performed perioperatively to provide anesthesia and analgesia for various surgical procedures on the upper limb. These blocks are performed with the aid of an ultrasound machine to improve the success rate. Below the clavicle approach to these nerves is used for surgeries below the elbow, forearm and hand efficiently.
Ultrasound guidance for such blocks allows direct visualisation of the needle and the spread of the freezing medication (local anesthetic) in real-time therefore reducing complications and improving success rates of blocks. It may be possible that a smaller volume of local anesthetic in this setting may allow effective anesthesia while lowering the adverse effects. The aim of this study is to find out the lowest volume of the local anesthetic that will be effective in blocking the nerves adequately.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a dose finding study. Volume assignment of ropivacaine will be carried out using a Biased Coin Design up and down method. In this method, the volume of local anesthetic (ropivacaine) administered to each patient will depends on the response of the previous patient. In the event of block failure, the next subject will receive an additional 2 mL of volume compared with the previous patient. In the event of block success, the next patient will receive either the same volume as the last patient or a 2 mL reduction in volume (per the biased coin design with a probability of the same volume being 0.9 and lower volume being 0.1). The first patient in the study will receive 30 mL and depending on the block success, the volume of the next block will be increased or decreased. The biased coin design is well described and established in other minimum volume studies.
All patients will have the block in the block room with standard monitoring (non-invasive blood pressure, pulse-oximetry, electrocardiogram) and mild sedation with midazolam and fentanyl. All blocks will be performed by staff anesthesiologists with a subspecialty in regional anesthesia and who work routinely in the block room or by a resident or fellow who is directly supervised by one of these staff anesthesiologist.
There will be two follow up telephone call to all patients enrolled in this study 24 hours post block insertion and one at 7 days to discuss length of block duration, any postoperative nausea/vomiting, any ongoing numbness or tingling, and overall satisfaction with the block. The participants will be informed of this phone call as part of the consent process and their telephone number will be confirmed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Ropivacaine dosage Dose finding study - The volume of 0.5% ropivacaine used to achieve surgical anesthesia in infraclavicular brachial plexus block |
Drug: Dose of ropivacaine
Biased coin design up and down dose finding study of 0.5% ropivacaine to achieve a successful infraclavicular brachial plexus block
|
Outcome Measures
Primary Outcome Measures
- ED90 of 0.5% Ropivacaine [30 minutes]
Volume used to achieve sensory and motor blockade (surgical anesthesia)
Secondary Outcome Measures
- Surgical anesthesia [30 minutes]
Sensory and motor blockade tested using pin prick sensation ( 0 - normal sensation and can feel pin-prick, 1 - touch only, 2 - no sensation of touch or pinprick) and motor function of the ulnar, radial and median nerves.
Other Outcome Measures
- Duration of sensory anesthesia [8 to 10 hours]
Duration of analgesia - time from administration of block to Visual analogue scale score more than 4 or patient request for first analgesic dose
- Complications during block placement [30 minutes]
Incidence of paresthesia during needle insertion, vascular or pleural puncture
- Postoperative complications 24 hours and 7 days [24 hours and 7 days]
Presence or absence of tingling, numbness, weakness of limb will be noted. Patient satisfaction as satisfied or unsatisfied will be noted.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged 18 to 80 years
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Amercian Society of Anesthesia physical status I, II, III
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Patients undergoing upper limb surgeries (with/without sedation)
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Ability to provide written informed consent
Exclusion Criteria:
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Patient refusal
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Known history of sensitivity or contraindications to study drugs
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Pregnant patients
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Infection at the site of administration of block
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Significant blood coagulation disorders
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Neurological deficits involving brachial plexus
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Patients on any medication which is known to have drug interactions with the study drugs
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Patients who receive general anesthesia/ narcotic supplements
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 112062