Total Shoulder Arthroplasty Clinical Trial
Official title:
Pain Management After Total Shoulder Arthroplasty: Continuous Interscalene Block Versus Local Tissue Infiltration With Liposomal Bupivacaine
Verified date | July 2017 |
Source | The Christ Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to determine if pain management after total shoulder arthroplasty
is more efficacious with ultrasound guided, continuous Interscalene block or with local
tissue infiltration with liposomal bupivacaine.
Traditionally, general anesthesia followed by narcotics has been the primary management of
pain control. However, regional anesthesia in the form of an interscalene block (ISB), a
perineural local anesthetic infusion, is commonly used and may more effectively control pain
during and after shoulder arthroplasty, with fewer side effects than narcotics.
Intraoperative benefits include better control of blood pressure and reduced need for general
anesthesia and narcotics. Depending on the type of block (single shot vs. continuous) and the
type of local anesthetic administered, pain relief may persist for 12-96 hours
postoperatively.
However, not all patients are candidates for peripheral nerve blocks. Pre-existing pulmonary
disease, previous neck surgery, cervical arthritis, neurologic disorders and obesity may
preclude ISB placement. As well, interscalene blocks are not completely benign procedures.
Systemic complications include clinically significant intraoperative hypotension,
pneumothorax, vascular injury, cardiac arrest, respiratory failure, seizure and death.
Phrenic nerve paralysis is common, although transient. Peripheral nerve injuries related to
mechanical injury, medication neurotoxicity, compression or ischemia are infrequent but may
be devastating. The experience and number of blocks performed by the anesthesiologist in
addition to adjunctive tools, such as ultrasound and/or nerve stimulators, impacts the
success of the procedure.
Continuous indwelling interscalene blocks (CISB) may provide substantial and longer pain
relief, precluding the need for perioperative narcotics. Earlier discharge post procedure and
better early range of motion are other purported benefits. However, premature catheter
failure, catheter breakage, infection, over administration of medication and extended
diaphragmatic paresis are concerns. In addition, there is a cost associated with these
procedures. The anesthesiologist fee, catheter with or without elastomeric pump, local
anesthetic, perioperative patient evaluation and treatment of any associated complications
all must be considered.
. The development of new, long acting local anesthetics, such as liposomal bupivacaine, is
potentially important in the management of perioperative pain. Liposomal bupivacaine has been
approved by the US Food and Drug Administration for local infiltration for pain relief after
bunionectomy and hemorrhoidectomy. This preparation increases the duration of local
anesthetic action by slow release from the liposome and delays the peak plasma concentration
when compared to plain bupivacaine administration. Studies have shown it to be an effective
tool for postoperative pain relief with opioid sparing effects and it has also been found to
have an acceptable adverse effect profile.
Status | Terminated |
Enrollment | 22 |
Est. completion date | September 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Patients must be between 18-75 years of age. 2. Patients must be candidates for primary total shoulder arthroplasty or reverse total shoulder arthroplasty. 3. Patients are determined by the investigator to be suitable candidates. 4. Patients must be able to understand and comply with protocol procedures. 5. Surgery must be performed at The Christ hospital Joint and Spine Center. 6. Patients must have BMI < 40 kg/m2 7. Patients must weigh a minimum of 50 kg. 8. Patients must have an American Society of Anesthesiologists(ASA) physical status I to III. Exclusion Criteria: 1. Shoulder arthroplasty performed for an acute proximal humerus fracture. 2. Allergy or intolerance to Bupivacaine or ropivacaine. 3. Allergy to study medications: midazolam, fentanyl, hydromorphone, or oxycodone. 4. History of chronic pain, chronic narcotic use or allergy to narcotics. 5. Previous neck surgery or other anatomic abnormalities which would preclude interscalene block. 6. Failure of interscalene block placement. 7. Patients with end-stage hepatic disease. 8. Patients with end-stage renal disease requiring dialysis. 9. Patients who are pregnant. |
Country | Name | City | State |
---|---|---|---|
United States | The Christ Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Christ Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NPRS-11 Pain Scores | The Numeric Pain Rating Scale(NPRS) is an 11 point scale with 0 being no pain and 10 being extreme pain. Patients select a value that is most in line with the intensity of pain that they have experienced. | Pre-Operatively | |
Primary | NPRS-11 Pain Scores | The Numeric Pain Rating Scale(NPRS) is an 11 point scale with 0 being no pain and 10 being extreme pain. Patients select a value that is most in line with the intensity of pain that they have experienced. Every 15 minutes while in the Post Anesthesia Recovery Unit (PACU) | Upon Arrival to PACU through discharge from PACU up to 4 hours. | |
Primary | NPRS-11 Pain Scores | The Numeric Pain Rating Scale(NPRS) is an 11 point scale with 0 being no pain and 10 being extreme pain. Patients select a value that is most in line with the intensity of pain that they have experienced every 4 hours while in the Post-Operative patient Unit. | Upon arrival to the Patient Care Unit through Hospital Discharge up to 3 days. | |
Primary | NPRS-11 Pain Scores | The Numeric Pain Rating Scale(NPRS) is an 11 point scale with 0 being no pain and 10 being extreme pain. Patients select a value that is most in line with the intensity of pain that they have experienced. | Pain scores will be recorded twice a day from hospital discharge until Post-Operative Day 7. | |
Secondary | Narcotic utilization | Collected in morphine sulfate equivalents | Daily through Day 7 post-op | |
Secondary | Length of Stay | Collected in hourly time increments | From Arrival to PACU through discharge form PACU up to 4 hours. | |
Secondary | Length of Stay | The amount of time the patient spent in the hospital in hourly increments. | From Hospital admission until hospital discharge up to 3 days. | |
Secondary | Discharge Status | Will patient be discharged home or to a Skilled Nursing Facility | Upon patient discharge from the hospital up to 3 days. | |
Secondary | Procedure Cost | Record the cost of the interscalene block procedure and medication versus the cost of the liposomal bupivacaine injection. | Through hospitalization, generally 3 days | |
Secondary | Range of Motion | This exam will include active and passive elevation, active and passive external rotation, active and passive abduction and internal rotation. | 2 weeks, 6 weeks, and 12 weeks postoperatively | |
Secondary | Neurovascular Status | This exam will evaluate motor function and sensation of the operative limb. | 2weeks, 6 weeks, and 12 weeks post-operatively |
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