Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture
Information source: University of New Mexico
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Ropivacine and Chloroprocaine mixture (Drug); Ropivacaine only (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of New Mexico
Summary
A double blinded randomized controlled trial comparing the onset and duration of the Onset
and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local
anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic
(Ropivacaine-Chloroprocaine Mixture).
Clinical Details
Official title: Double Blinded Randomized Control Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Onset of surgical anesthesia
Secondary outcome: Duration of analgesia
Detailed description:
Patients will be met preoperatively in the pre-anesthesia holding area as is typical for
most orthopedic procedures. An attending anesthesiologist will evaluate the patient and
planned surgical procedure and determine if the best anesthetic plan includes a
supraclavicular brachial plexus block and will ensure that the patient provides informed
consent for their anesthetic plan. Patients who will be having a supraclavicular brachial
plexus block as part of their anesthetic will be approached for possible inclusion in the
study.
The patient's surgical site will be verified by standard time out procedure. Standard
monitoring will be placed including pulse oximetry, EKG, and non-invasive blood pressure
cuff. A nasal canula will be placed to provide oxygen. The patient may be given midazolam
IV up to 0. 05 mg/kg as needed for anxiolysis. The supraclavicular brachial plexus block
will be performed by either the attending anesthesiologist or a resident physician directly
supervised by the attending anesthesiologist using ultrasound guidance.
The randomization envelope will be handed to an anesthesiologist not involved in the
patient's care who will fill a 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's
of normal saline + 0. 1 ml of 1mg/ml epinephrine or 20 ml's of 1% ropivacaine + 10 ml's of 3%
2-chloroprocaine + 0. 1 ml of 1 mg/ml epinephrine. The patient and the physicians performing
the nerve block and the assessment after the block,will be blinded to the type of local
anesthetic injected.
The physician performing the block will use standard aseptic technique and local anesthetic
infiltration of the skin. Then, using ultrasound guidance and a 22g Touhy needle, a
supraclavicular brachial plexus block will be placed using 25 mls of the study drug. The
time of beginning of injection will be recorded. Starting at 10 minutes after injection,
motor and sensory exam in the distribution of the ulnar, median, radial and musculocutaneous
nerves using pinprick every 3 minutes until motor block and sensory block is complete. As
has been used in prior studies, motor scores of 0, 1, and 2 will be used for no motor
blockade (0), partial motor blockade (1), and complete motor blockade (2). Similarly,
sensory scores will reflect no change in pinprick sensitivity (0), diminished pinprick
sensitivity (1), and complete loss of sensitivity to pinprick (2). Being ready for surgical
anesthesia will be defined as a score of 2 for sensory testing. Any patient not achieving a
score of 2 on the sensory scale by 40 minutes will be considered a failed block. These
scores will be recorded every 3 minutes until the block achieves scores of 2 and 2 or until
the patient goes to the operating room (OR).
Once in the OR, data will be collected on whether or not the patient experienced pain on
incision, required supplemental pain medicine or sedation, or if the patient required
general anesthesia and the reason for needing general anesthesia (e. g. patient discomfort,
surgeon request, etc). Post-operatively, a motor and sensory exam will again be performed
on the patients for whom the nerve block did not achieve scores of 2 and 2 prior to
undergoing surgery and on the patients who required general anesthesia. The patient will be
given a card as a reminder to write down the time when he/she noticed pain at site of the
operation for the first time and separately the time when he/she took pain medication for
the first time. The night of the surgery the patient will be contacted over the phone by one
of the investigators to ask the time of pain onset and pain medication administration.
Additional data regarding the patient age, weight, type of surgery, and sex will be
recorded.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who will be having a supraclavicular brachial plexus block as part of their
anesthetic will be approached for possible inclusion in the study
Exclusion Criteria:
- patients who are pregnant,
- have an ASA status of IV or greater,
- neuropathy,
- a cast or other impediment to performing a motor or sensory exam in the arm and hand,
- patients under the age of 18,
- long term opioid therapy (longer than 1 month),
- history of opioid abuse and pseudocholinesterase deficiency
Locations and Contacts
University of New Mexico, Albuquerque, New Mexico 87106, United States
Additional Information
Starting date: August 2009
Last updated: October 31, 2012
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