Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01719237 |
| Other study ID # |
ChloroRopiSCB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 2009 |
| Est. completion date |
November 2010 |
Study information
| Verified date |
October 2012 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
