MEV 90 of 0.5% Ropivacaine In Infraclavicular Blocks

NCT03824717 | Unknown DMC

• 1 other identifier: 112062
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infraclavicular Brachial Plexus Block

Keywords

Ropivacaine; Brachial plexus block; Infraclavicular block

Outcome Measures

Primary Outcomes (1)

• ED90 of 0.5% Ropivacaine

  Volume used to achieve sensory and motor blockade (surgical anesthesia)

  30 minutes

Secondary Outcomes (1)

• Surgical anesthesia

  30 minutes

Other Outcomes (3)

• Duration of sensory anesthesia

  8 to 10 hours

• Complications during block placement

  30 minutes

• Postoperative complications 24 hours and 7 days

  24 hours and 7 days

Study Arms (1)

Ropivacaine dosage

OTHER

Dose finding study - The volume of 0.5% ropivacaine used to achieve surgical anesthesia in infraclavicular brachial plexus block

Drug: Dose of ropivacaine

Interventions

Dose of ropivacaine DRUG

Biased coin design up and down dose finding study of 0.5% ropivacaine to achieve a successful infraclavicular brachial plexus block

Ropivacaine dosage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 80 years
• Amercian Society of Anesthesia physical status I, II, III
• Patients undergoing upper limb surgeries (with/without sedation)
• Ability to provide written informed consent

You may not qualify if:

• Patient refusal
• Known history of sensitivity or contraindications to study drugs
• Pregnant patients
• Infection at the site of administration of block
• Significant blood coagulation disorders
• Neurological deficits involving brachial plexus
• Patients on any medication which is known to have drug interactions with the study drugs
• Patients who receive general anesthesia/ narcotic supplements

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Central Study Contacts

Shalini Dhir, MD, FRCPC

CONTACT

+1 519 646 6000; shalini.dhir@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There is no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Biased coin design and up and down method to determine the minimum effective volume of Ropivacaine in ultrasound guided infraclavicular brachial plexus blocks.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 31, 2019
• Study Start: January 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 31, 2019

Record last verified: 2019-01