Arthroplasty ShoulderNCT03253198
Prospective RCT Comparing Perioperative Pain
A study testing Saline and Bupivacaine liposome in people with Arthroplasty Shoulder, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty Shoulder
- What is being tested?
- Saline and Bupivacaine liposome
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Thomas Jefferson University Hospital, Methodist Hospital or Rothman Specialty Hospital.
Who cannot join
- Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
- Revision arthroplasty or arthroplasty for fracture
- Unable/unwilling to consent for enrollment
- Unable to complete postoperative pain survey
- Known adverse drug reaction or allergy to the medications used
- Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
Show all 10Show fewer
- Patients taking long acting opioid pain medications (including extended release opioid pain medications and methadone)
- Patients under the age of 18 years
- Patients with history of hepatic disease
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Interscalene Nerve Block Plus Postoperative Local Intra-operative Analgesic Injection vs Preoperative Interscalene Nerve Block Plus Postoperative Saline Injection in Patients Undergoing Shoulder Arthroplasty: a Randomized Trial
This study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. To do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid consumption will be recorded on a Pain Monitoring Sheet.
- Conditions
- Arthroplasty Shoulder
- Being tested
- Saline, Bupivacaine liposome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
A preoperative interscalene brachial plexus single-shot block using 25 ml of 0.5% Ropivicaine plus saline injection postoperative
Bupivacaine liposomeDrug
an interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)
| Study group | Role | What they receive |
|---|---|---|
| Preoperative block plus saline | Active comparator | Preoperative interscalene brachial plexus single-shot block using 25ml of 0.5% Ropivicaine plus postoperative 40cc local infiltration of saline Receives: Drug: Saline |
| Preoperative block plus Bupivacaine extended-release liposome | Active comparator | Interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues) Receives: Drug: Bupivacaine liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine and morphine equivalent consumption
Measured: 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startAug 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ShoulderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surena Namdari, MD, Principal investigator, Rothman Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253198
- Sponsor's protocol ID
- 2017SNam
- Status last verified
- May 2018
- First submitted
- 15 Aug 2017
- Last updated
- 22 May 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Interscalene Nerve Block Plus Postoperative Local Intra-operative Analgesic Injection vs Preoperative Interscalene Nerve Block Plus Postoperative Saline Injection in Patients Undergoing Shoulder Arthroplasty: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03253198
- Acronym / sponsor ID
- 2017SNam
- Conditions
- Arthroplasty Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. To do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid consumption will be recorded on a Pain Monitoring Sheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative block plus saline | Active comparator | Drug: SalinePreoperative interscalene brachial plexus single-shot block using 25ml of 0.5% Ropivicaine plus postoperative 40cc local infiltration of saline |
| Preoperative block plus Bupivacaine extended-release liposome | Active comparator | Drug: Bupivacaine liposomeInterscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Thomas Jefferson University Hospital, Methodist Hospital or Rothman Specialty Hospital.
Key exclusion criteria (10 listed)
- Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
- Revision arthroplasty or arthroplasty for fracture
- Unable/unwilling to consent for enrollment
- Unable to complete postoperative pain survey
- Known adverse drug reaction or allergy to the medications used
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 |
|---|---|---|
| SalineA preoperative interscalene brachial plexus single-shot block using 25 ml of 0.5% Ropivicaine plus saline injection postoperative | Drug | Preoperative block plus saline |
| Bupivacaine liposomean interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues) | Drug | Preoperative block plus Bupivacaine extended-release liposome |
Primary outcome
morphine and morphine equivalent consumption
Time frame: 24 hours post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- 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.
Surena Namdari, MD principal investigator
Rothman Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline and Bupivacaine liposome in people with Arthroplasty Shoulder, run by Rothman Institute Orthopaedics 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 1 inclusion and 10 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 22 May 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
morphine and morphine equivalent consumption (time frame: 24 hours post surgery). 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 22 May 2018.