Primary Osteoarthritis, Unspecified ShoulderNCT02267044
Effective Pain Management of Interscalene Blocks During Shoulder Surgery
A study testing Ropivacaine in people with Primary Osteoarthritis, Unspecified Shoulder, run by TriHealth Inc. at 1 site in United States.
Trial summary
Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Osteoarthritis, Unspecified Shoulder
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Surgical candidate for primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement
- patient must be 18 years or older and willing to sign and date an Institutional Review Board informed consent form, and
- must be able to understand and agree to follow study protocol.
Who cannot join
- severe bronchopulmonary disease,
- oxygen dependent,
- existing nerve injury,
- BMI > 40,
- coagulation disorders,
- allergy to ropivicaine,
Show all 9Show fewer
- history of drug or alcohol abuse,
- American Academy of Anaesthesiologists physical status classification > lll,
- pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Pain Management of Continuous Versus Single Shot Injection Interscalene Block During Shoulder Replacement Surgery
Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. The purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient.
Patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.
Read the detailed description
This is a prospective randomized controlled trial. 76 patients receiving either primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement will be randomized to a regional anesthesia technique as part of their surgical procedure. 38 patients will receive a single shot interscalene block containing ropivicaine and 38 patients will receive a continuous interscalene block containing ropivicaine.
- Being tested
- Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
The drug used for the interscalene blocks
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine Single Shot Block | Active comparator | Single Shot Interscalene block patients will receive a single shot of 30ml of 0.5% Ropivacaine prior to surgery Receives: Drug: Ropivacaine |
| Ropivacaine Continuous block | Active comparator | Continuous Interscalene block patients will receive a shot of up to 30ml of 0.5% Ropivacaine and then a catheter is placed. The catheter is secured with Dermabond and Tegaderm. Once surgery is complete, the catheter is connected to a pain ball system which holds 400ml of 0.2% Ropivacaine local anesthetic. The rate is locked in at 8ml/hr. Catheter is pulled once the pain ball is empty. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score Measure
Patients will be assessed for pain levels by visual analog scale while in the hospital per nursing protocol. Electronic Medical Record will be used to acquire pain scores.
Measured: participants will be followed for the duration of the hospital stay, an expected average of 3 days
Secondary outcomes (2)
Morphine Sulfate Equivalence consumption
Total Morphine Sulfate equivalence consumption for each post-operative day while in the hospital will be collected through Electronic medical record.
Measured: participants morphine sulfate consumption will be gathered for the duration of the hospital stay, an expected average of 3 days
Pain control Satisfaction Score
Patient's post operative pain control satisfaction score will be obtained at the first post operative follow up visit with the physician which is expected to occur on avearage 10 days after surgery
Measured: 10 day post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Osteoarthritis, Unspecified 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samer Hasan, MD, Principal investigator, Cincinnati Sportsmedicine and Orthopaedic CenterRobert Rolf, MD, Principal investigator, Beacon Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267044
- Sponsor's protocol ID
- 14061
- Status last verified
- Oct 2018
- First submitted
- 12 Aug 2014
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Borgeat A, Tewes E, Biasca N, Gerber C. Patient-controlled interscalene analgesia with ropivacaine after major shoulder surgery: PCIA vs PCA. Br J Anaesth. 1998 Oct;81(4):603-5. doi: 10.1093/bja/81.4.603.
PubMed 9924240
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Pain Management of Continuous Versus Single Shot Injection Interscalene Block During Shoulder Replacement Surgery
- ClinicalTrials.gov ID
- NCT02267044
- Acronym / sponsor ID
- 14061
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Oct 2014 (estimated)
- 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.
Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. The purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient.
Patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.
Detailed description
This is a prospective randomized controlled trial. 76 patients receiving either primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement will be randomized to a regional anesthesia technique as part of their surgical procedure. 38 patients will receive a single shot interscalene block containing ropivicaine and 38 patients will receive a continuous interscalene block containing ropivicaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine Single Shot Block | Active comparator | Drug: RopivacaineSingle Shot Interscalene block patients will receive a single shot of 30ml of 0.5% Ropivacaine prior to surgery |
| Ropivacaine Continuous block | Active comparator | Drug: RopivacaineContinuous Interscalene block patients will receive a shot of up to 30ml of 0.5% Ropivacaine and then a catheter is placed. The catheter is secured with Dermabond and Tegaderm. Once surgery is complete, the catheter is connected to a pain ball system which holds 400ml of 0.2% Ropivacaine local anesthetic. The rate is locked in at 8ml/hr. Catheter is pulled once the pain ball is empty. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Surgical candidate for primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement
- patient must be 18 years or older and willing to sign and date an Institutional Review Board informed consent form, and
- must be able to understand and agree to follow study protocol.
Key exclusion criteria (9 listed)
- severe bronchopulmonary disease,
- oxygen dependent,
- existing nerve injury,
- BMI > 40,
- coagulation disorders,
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 |
|---|---|---|
| RopivacaineAlso: NaropinThe drug used for the interscalene blocks | Drug | Ropivacaine Continuous block, Ropivacaine Single Shot Block |
Primary outcome
Pain Score Measure
Time frame: participants will be followed for the duration of the hospital stay, an expected average of 3 days
Patients will be assessed for pain levels by visual analog scale while in the hospital per nursing protocol. Electronic Medical Record will be used to acquire pain scores.
2 secondary outcomes
Morphine Sulfate Equivalence consumption
Time frame: participants morphine sulfate consumption will be gathered for the duration of the hospital stay, an expected average of 3 days
Pain control Satisfaction Score
Time frame: 10 day post operative
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 26 Oct 2018.
- Background: PubMed 9924240Borgeat A, Tewes E, Biasca N, Gerber C. Patient-controlled interscalene analgesia with ropivacaine after major shoulder surgery: PCIA vs PCA. Br J Anaesth. 1998 Oct;81(4):603-5. doi: 10.1093/bja/81.4.603.
- Individual participant dataSharing planned: Undecided
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.
Samer Hasan, MD principal investigator
Cincinnati Sportsmedicine and Orthopaedic Center
Robert Rolf, MD principal investigator
Beacon Orthopaedic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Primary Osteoarthritis, Unspecified Shoulder, run by TriHealth Inc. 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 3 inclusion and 9 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 26 Oct 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?
Pain Score Measure (time frame: participants will be followed for the duration of the hospital stay, an expected average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267044, which also lists 1 linked publication.
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 26 Oct 2018.