Pain Management After Total Shoulder Arthroplasty

NCT03219983 | Terminated Phase 4 FDA Drug

• 1 other identifier: Total Shoulder
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Glenohumeral Arthritis; Total Shoulder Arthroplasty

Keywords

interscalene block; liposomal bupivacaine

Outcome Measures

Primary Outcomes (4)

• 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

• 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.

• 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.

• 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 Outcomes (7)

• Narcotic utilization

  Daily through Day 7 post-op

• Length of Stay

  From Arrival to PACU through discharge form PACU up to 4 hours.

• Length of Stay

  From Hospital admission until hospital discharge up to 3 days.

• Discharge Status

  Upon patient discharge from the hospital up to 3 days.

• Procedure Cost

  Through hospitalization, generally 3 days

Study Arms (2)

Interscalene Block

ACTIVE COMPARATOR

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

Deep soft tissue/surgical site injection

ACTIVE COMPARATOR

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

Interventions

Ropivacaine DRUG

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)

Also known as: There is not another intervention involved.

Interscalene Block

liposomal bupivacaine DRUG

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.

Also known as: there is not another intervention involved. Please explain to me what you are referring to.

Deep soft tissue/surgical site injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be between 18-75 years of age.
• Patients must be candidates for primary total shoulder arthroplasty or reverse total shoulder arthroplasty.
• Patients are determined by the investigator to be suitable candidates.
• Patients must be able to understand and comply with protocol procedures.
• Surgery must be performed at The Christ hospital Joint and Spine Center.
• Patients must have BMI \< 40 kg/m2
• Patients must weigh a minimum of 50 kg.
• Patients must have an American Society of Anesthesiologists(ASA) physical status I to III.

You may not qualify if:

• Shoulder arthroplasty performed for an acute proximal humerus fracture.
• Allergy or intolerance to Bupivacaine or ropivacaine.
• Allergy to study medications: midazolam, fentanyl, hydromorphone, or oxycodone.
• History of chronic pain, chronic narcotic use or allergy to narcotics.
• Previous neck surgery or other anatomic abnormalities which would preclude interscalene block.
• Failure of interscalene block placement.
• Patients with end-stage hepatic disease.
• Patients with end-stage renal disease requiring dialysis.
• Patients who are pregnant.

Sponsors & Collaborators

• The Christ Hospital: lead

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: July 18, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)