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Pain Management After Total Shoulder Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219983
Recruitment Status : Terminated
First Posted : July 18, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Paul Favorito, The Christ Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Glenohumeral Arthritis Total Shoulder Arthroplasty Drug: Ropivacaine Drug: liposomal bupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Management After Total Shoulder Arthroplasty: Continuous Interscalene Block Versus Local Tissue Infiltration With Liposomal Bupivacaine
Actual Study Start Date : November 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Interscalene Block
Ultrasound guided interscalene catheter will be placed and a 30 ml .5% ropivacaine will be given pre-operatively. Upon arrival to the Post-Operative Care Unit a continuous infusion of .5% ropivacaine will be started at 8ml/hr and increased by 2ml/hr every 15 minutes for pain score > 4 with a maximum rate of 14ml/hr. Infusion will be delivered by ON-Q Select-a-Flow pump (volume 750ml)
Drug: Ropivacaine
Patients will have an interscalene block under ultrasound guidance and receive .5% ropivacaine pre-operatively. Upon arrival to the Post-Operative Care Unit a continuous infusion of .5% ropivacaine will be started at 8ml/hr and increased by 2ml/hr every 15 minutes for pain score > 4 with a maximum rate of 14ml/hr. Infusion will be delivered by ON-Q Select-a-Flow pump (volume 750ml)
Other Name: There is not another intervention involved.

Active Comparator: Deep soft tissue/surgical site injection
A total volume of 100ml will be comprised of 60ml of 0.9% normal saline + 20ml 0.5% bupivacaine + 20ml liposomal bupivacaine will be injected into the deep soft tissue using an 18 or 20 gauge needle prior to or after prosthesis insertion
Drug: liposomal bupivacaine
A total injection volume of 100ml will be comprised of 60ml 0.9% normal saline+ 20ml .5% bupivacaine + 20ml liposomal bupivacaine will be administered into the deep tissue of the operative are with an 18 or 20 gauge needle.
Other Name: there is not another intervention involved. Please explain to me what you are referring to.




Primary Outcome Measures :
  1. NPRS-11 Pain Scores [ Time Frame: Pre-Operatively ]
    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.

  2. NPRS-11 Pain Scores [ Time Frame: Upon Arrival to PACU through discharge from PACU up to 4 hours. ]
    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)

  3. NPRS-11 Pain Scores [ Time Frame: Upon arrival to the Patient Care Unit through Hospital Discharge up to 3 days. ]
    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.

  4. NPRS-11 Pain Scores [ Time Frame: Pain scores will be recorded twice a day from hospital discharge until Post-Operative Day 7. ]
    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.


Secondary Outcome Measures :
  1. Narcotic utilization [ Time Frame: Daily through Day 7 post-op ]
    Collected in morphine sulfate equivalents

  2. Length of Stay [ Time Frame: From Arrival to PACU through discharge form PACU up to 4 hours. ]
    Collected in hourly time increments

  3. Length of Stay [ Time Frame: From Hospital admission until hospital discharge up to 3 days. ]
    The amount of time the patient spent in the hospital in hourly increments.

  4. Discharge Status [ Time Frame: Upon patient discharge from the hospital up to 3 days. ]
    Will patient be discharged home or to a Skilled Nursing Facility

  5. Procedure Cost [ Time Frame: Through hospitalization, generally 3 days ]
    Record the cost of the interscalene block procedure and medication versus the cost of the liposomal bupivacaine injection.

  6. Range of Motion [ Time Frame: 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    This exam will include active and passive elevation, active and passive external rotation, active and passive abduction and internal rotation.

  7. Neurovascular Status [ Time Frame: 2weeks, 6 weeks, and 12 weeks post-operatively ]
    This exam will evaluate motor function and sensation of the operative limb.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219983


Locations
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United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
The Christ Hospital
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Responsible Party: Dr. Paul Favorito, Principal Investigator, The Christ Hospital
ClinicalTrials.gov Identifier: NCT03219983    
Other Study ID Numbers: Total Shoulder
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Paul Favorito, The Christ Hospital:
interscalene block
liposomal bupivacaine
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents