Pain, PostoperativePhase 4NCT02876055
Analgesic Efficacy of Interscalene Nerve Block Versus Local Infiltration Analgesia Following Total Shoulder Arthroplasty
A Phase 4 study testing Single shot interscalene nerve block, Continuous interscalene nerve block and Local Infiltration Analgesia (LIA) in people with Pain, Postoperative, run by Mayo Clinic at 1 site in United States.
Trial summary
Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in severe postoperative pain, especially in the first 48 hours after surgery. The use of interscalene brachial plexus nerve block remains the cornerstone for analgesia following shoulder surgery; however, with the advent of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Single shot interscalene nerve block, Continuous interscalene nerve block and Local Infiltration Analgesia (LIA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Feb 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
- Patients 18 years of age and older
- Able to provide informed consent for him or herself
Who cannot join
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- Chronic opioid use (>1 mos) with oral morphine equivalents (OME) >5 mg/day OR acute opioid use (< 1 mos) with OME > 30 mg/day.
- Body mass index (BMI) > 45 kg/m2
- Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics.
- History of Malignant Hyperthermia.
- Major systemic medical problems such as:
Show all 15Show fewer
- Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
- Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
- Pre-existing medical history of moderate to severe pulmonary disease (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation < 94% on room air, forced expiratory volume in 1 second (FEV 1) < 60% of predicted value (obstructive disease), vital capacity (VC) or total lung capacity (TLC) < 70% predicted value (restrictive disease).37
- History of contralateral hemidiaphragmatic dysfunction (e.g., paralysis) or phrenic nerve injury.
- Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, refusal, anticoagulation medications not held within appropriate time frame per American Society of Regional Anesthesia (ASRA) guidelines.
- Previous contralateral total shoulder replacement managed with regional anesthetic nerve block or periarticular injection/intraarticular injection within the previous 12 months.
- Known to be currently pregnant or actively breastfeeding++
- ++ Patients that have a previous history of menopause, hysterectomy, or tubal ligation will not be required to perform a pregnancy test.
- Impaired cognition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized Controlled Trial Comparing Analgesic Efficacy of Single Injection vs. Continuous Interscalene Blockade vs. Local Infiltration Analgesia for Patients Undergoing Primary Total Shoulder Arthroplasty
Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in severe postoperative pain, especially in the first 48 hours after surgery. The use of interscalene brachial plexus nerve block remains the cornerstone for analgesia following shoulder surgery; however, with the advent of local infiltration analgesia (LIA), there has been increasing interest in its use for total joint arthroplasty.
Since the benefits of local infiltration analgesia within a comprehensive multi-modal analgesia clinical pathway have yet to be established for total shoulder arthroplasty, the Investigators plan to assess and compare analgesia outcomes between three intervention groups: single shot interscalene brachial plexus block (SISB), continuous interscalene brachial plexus block (CISB), and local infiltration analgesia (LIA).
- Conditions
- Pain, Postoperative
- Being tested
- Single shot interscalene nerve block, Continuous interscalene nerve block, Local Infiltration Analgesia (LIA)
- Keywords
- Nerve Block/methods, Pain, Postoperative/prevention & control, Anesthetics, Local/administration & dosage, Brachial Plexus/ultrasonography, Shoulder Pain/prevention & control
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single shot interscalene nerve blockDrug
Also called Interscalene brachial plexus block
Peripheral regional anesthesia nerve block - Single shot interscalene nerve block
Continuous interscalene nerve blockDrug
Also called Interscalene brachial plexus block
Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block
Local Infiltration Analgesia (LIA)Drug
Also called Arthroplasty Block, Peri-articular Injection
Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery
| Study group | Role | What they receive |
|---|---|---|
| Single shot interscalene nerve block | Active comparator | An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered. Receives: Drug: Single shot interscalene nerve block |
| Continuous interscalene nerve block | Active comparator | An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.
Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the post-anesthesia care unit (PACU) with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour. Receives: Drug: Continuous interscalene nerve block |
| Local Infiltration Analgesia (LIA) | Experimental | The LIA group will utilize weight based dosing of Ropivacaine as part of a "cocktail" solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia. Receives: Drug: Local Infiltration Analgesia (LIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS).
The OBAS score was calculated using the sum of the scores from six questions. OBAS ranges from 0 (best) to 28 (worst), where a low score indicates a high benefit to the subjects.
Measured: Post-Operative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason K. Panchamia, D.O., Mayo Clinic
- Investigators
- Jason K Panchamia, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876055
- Sponsor's protocol ID
- 15-009646
- Status last verified
- Mar 2019
- First submitted
- 18 Aug 2016
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Controlled Trial Comparing Analgesic Efficacy of Single Injection vs. Continuous Interscalene Blockade vs. Local Infiltration Analgesia for Patients Undergoing Primary Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT02876055
- Acronym / sponsor ID
- 15-009646
- Conditions
- Pain, Postoperative
- Keywords
- Nerve Block/methods, Pain, Postoperative/prevention & control, Anesthetics, Local/administration & dosage, Brachial Plexus/ultrasonography, Shoulder Pain/prevention & control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in severe postoperative pain, especially in the first 48 hours after surgery. The use of interscalene brachial plexus nerve block remains the cornerstone for analgesia following shoulder surgery; however, with the advent of local infiltration analgesia (LIA), there has been increasing interest in its use for total joint arthroplasty.
Since the benefits of local infiltration analgesia within a comprehensive multi-modal analgesia clinical pathway have yet to be established for total shoulder arthroplasty, the Investigators plan to assess and compare analgesia outcomes between three intervention groups: single shot interscalene brachial plexus block (SISB), continuous interscalene brachial plexus block (CISB), and local infiltration analgesia (LIA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single shot interscalene nerve block | Active comparator | Drug: Single shot interscalene nerve blockAn interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered. |
| Continuous interscalene nerve block | Active comparator | Drug: Continuous interscalene nerve blockAn interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the post-anesthesia care unit (PACU) with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour. |
| Local Infiltration Analgesia (LIA) | Experimental | Drug: Local Infiltration Analgesia (LIA)The LIA group will utilize weight based dosing of Ropivacaine as part of a "cocktail" solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
- Patients 18 years of age and older
- Able to provide informed consent for him or herself
Key exclusion criteria (15 listed)
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- Chronic opioid use (>1 mos) with oral morphine equivalents (OME) >5 mg/day OR acute opioid use (< 1 mos) with OME > 30 mg/day.
- Body mass index (BMI) > 45 kg/m2
- Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics.
- History of Malignant Hyperthermia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single shot interscalene nerve blockAlso: Interscalene brachial plexus blockPeripheral regional anesthesia nerve block - Single shot interscalene nerve block | Drug | Single shot interscalene nerve block |
| Continuous interscalene nerve blockAlso: Interscalene brachial plexus blockPeripheral regional anesthesia nerve block - continuous catheter interscalene nerve block | Drug | Continuous interscalene nerve block |
| Local Infiltration Analgesia (LIA)Also: Arthroplasty Block, Peri-articular InjectionInjection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery | Drug | Local Infiltration Analgesia (LIA) |
Primary outcome
Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS).
Time frame: Post-Operative Day 1
The OBAS score was calculated using the sum of the scores from six questions. OBAS ranges from 0 (best) to 28 (worst), where a low score indicates a high benefit to the subjects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason K Panchamia, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Single shot interscalene nerve block, Continuous interscalene nerve block and Local Infiltration Analgesia (LIA) in people with Pain, Postoperative, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS). (time frame: Post-Operative Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.