Chronic Shoulder Pain Clinical Trial
Official title:
Analgesic Requirements for Post-operative Pain Control in Total Shoulder Replacement Patients: Comparison of Interscalene Single Shot Exparel (Bupivacaine Liposome) Injections to Cervical Paravertebral Catheter With Ropivacaine (0.2% Continuous Infusion)
Total shoulder surgery (arthroplasty) is a widely successful method of treating shoulder
arthritis. Although the goal of the procedure is pain relief, post-operative pain is
unavoidable. Pain is a common side effect that many patients undergo while in the clinical
setting and is a vital factor in influencing the length of hospital stay, narcotic usage, as
well as overall patient satisfaction. Post-operative pain management typically involves
elevated usage of narcotics, which is a concern among clinicians and researchers alike. To
combat this issue, research is examining intraoperative procedures as a means of reducing
post-operative pain scores.
Research has discovered the advantages of utilizing local anesthetic techniques as opposed to
just general anesthesia. Local anesthetic blocks function by preventing the generation of
nerve impulses by increasing the action-potential threshold, thereby inhibiting movement.
Previous studies have demonstrated the success of local anesthetic interscalene blocks across
several medical procedures. For instance, Exparel (liposomal bupivacaine) has been effective
in reducing post-operative pain scores in tonsillectomy and shoulder arthroplasty. Another
local anesthetic, Ropivacaine, has been found to be potent when utilized via a cervical
paravertebral catheter among thoracic procedures.
Our study will compare Exparel (bupivacaine liposome) with Ropivacaine continuous infusion
for post-operative pain scores in total shoulder surgery patients. Additionally, we will
collect data on complications, length of stay, and other variables.
Procedure Description:
The investigators commonly use these blocks for patients requiring total shoulder
replacement: the patient is usually sedated with propofol. The patient is positioned in the
lateral decubitus, or sitting position for this block. After the skin preparation and
draping, the fingers of the non-operative hand separate the trapezius and levator scapulae
muscle and a 25 gauge needle is used to anesthetize the skin and subcutaneous tissue.
The Trapezius and Levator Scapulae muscles are again separated with the non-operative hand
and a 17 or 18 gauge insulated tuohy needle is inserted, which is attached to a nerve
stimulator set at a current output of one to three milliamps, a frequency of two Hertz, and a
pulse width of 200 to 300 microseconds. The needle is advanced towards the suprasternal notch
until contact with the bony structures is made.
After contact with the bone the stylet of the needle is removed, the needle tip is walked off
the bony structures in a lateral and slightly superior direction remaining on the plane of
the line drawn from the dorsal spine of C6 to the suprasternal notch. After walking off of
these bones structures the needle is advanced carefully in an anterior direction. As the
needle is advanced there will be a motor response from the stimulator current. The muscles
involved are usually the triceps, biceps, deltoids or major pectoral muscle but any muscle
group of the upper limb would be acceptable for this block since the needle is now in contact
with the posterior aspects of the roots of the brachial plexus. The tip of the needle at this
point is situated between the anterior and middle scalene muscles and is in contact with the
C6 root of the brachial plexus. At this point either a single-shot injection of Exparel will
be performed, or a catheter for Ropivacaine will be inserted, as described below.
For catheter insertion: the nerve stimulator is removed from the needle and attached to the
proximal end of the stimulating catheter and the tip of the catheter is inserted into the
needle shaft. The nerve stimulator is usually set at a current output of one milliamp. The
motor response should be unchanged. The catheter is advanced beyond the needle tip, if the
motor response disappears, the catheter is careful drawn into the needle shaft and small
adjustment to the needle, advancing slightly or withdrawing it slightly is done. This
maneuver is repeated until the muscle twitch is unchanged during catheter advance. This
indicates the catheter tip is now situated on the nerve root; the catheter is advanced 3 to 5
centimeter beyond the needle tip but not further than 5 centimeters. The needle is then
removed without disturbing the catheter and the inner stylet of the catheter is also removed.
The catheter position can be confirmed by attaching the nerve stimulator to the catheter, the
motor response should be unchanged. The catheter is then subcutaneously tunneled and
continuous infusion of Ropivacaine is inserted.
Intraoperative Management:
The intraoperative course will follow the standard of care practices. Doses/concentration of
medications/agents used for the anesthetic management of the subjects enrolled in this trial
may be adjusted when necessary to provide optimal subject care. Anesthesia will be induced
with propofol, intravenous opioids, and other medication(s)/agent(s) at a concentration
range/dose(s) based on the clinical need of the subject. Patient will be given
succinylcholine to aid in intubation.
Anesthesia will be maintained in both groups with intravenous opioids, propofol and /or
medication(s)/agent(s), including inhalation anesthetic agents, at a concentration
range/dose(s) based on the clinical need of the subject.
Tracheal extubation will be performed at the end of anesthesia at which point the patient
will be discharged to the post-anesthesia care unit.
Postoperative Management:
Upon arrival in the PACU, the (sub)investigator, using the visual analog scale, will
clinically assess post-operative pain.
Assessment of patient pain levels involve a series of VAS testing postoperatively (upon
arrival and every 30 minutes postoperatively until discharge from the PACU) using a 10 cm
line. Patients that complain of pain intensity >5 cm/10 cm, will be given a standardized
rescue intravenous dilaudid regimen, IV dilaudid at 0.4mg up to a max dose of 2mg prn q 2
hours or until a VAS of <5 is obtained. If a VAS score of <5 cannot be obtained, the PI may
withdraw the patient from the study and administer another pain medication. Post-operative
PACU narcotic consumption will be recorded and quantified.
All patients will be monitored with continuous pulse-oximetry. All post-operative
complications will be captured.
Follow-up Period: All patients will have a planned hospital admission from the PACU. Pain
will be assessed every 2 hours for the first 24 hours followed by every 4 hours until
hospital discharge using the VAS scale. All post-operative complications will be captured.
Post-PACU narcotic consumption will be recorded and quantified for the first 72 hours after
PACU discharge.
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