PainPhase 4NCT02946268
Optimal Volume, Rate, and Interval of Bolus Nerve Catheters for Shoulder Surgery
A Phase 4 study testing Ropivacaine in people with Pain, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the ideal delivery of local anesthetics for pain control when using continuous interscalene peripheral nerve catheters for shoulder surgery. The study will be conducted in three stages. In the first stage the ideal bolus volume of ropivacaine will be determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2017to 21 Feb 2017
- Phase
- Phase 4
- 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
- Male or female, ≥18 years of age
- Patients scheduled to undergo unilateral shoulder surgery at Duke University Medical Center, including arthroscopic rotator cuff repair, acromioplasty, hemiarthroplasty, and total shoulder replacement.
- American Society of Anesthesiology (ASA) Physical Class 1-3.
- BMI ≤40 kg/m2
Who cannot join
- Patients with a contraindication to placement of interscalene nerve block. This includes abnormal clotting, skin infection involving the neck, the presence of neurological disorders or cervical spine disease, contralateral phrenic nerve dysfunction, or moderate-severe COPD (FEV1<80% of normal values and/or FEV1/FVC < 0.70)
- Patients with chronic pain (pain existing for longer than 6 months), or taking chronic opioids (greater than 60 morphine equivalents per day) at time of surgery
- Contraindications to or known drug interactions with local anesthetics
- Patients who will be discharged home directly from PACU
- Planned administration of another investigational product or procedure during the subject's participation in this study.
- Patients who do not have the capacity to give legally effective consent
Show all 10Show fewer
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Ambulatory Surgery Center
Durham, North Carolina, 27705
About this study
Official title: Up-down Sequential Allocation Study to Determine the Optimal Volume, Rate, and Interval of Bolus of Ropivacaine 0.2% in Interscalene Continuous Nerve Catheters for Shoulder Surgery
The purpose of this study is to determine the ideal delivery of local anesthetics for pain control when using continuous interscalene peripheral nerve catheters for shoulder surgery.
The study will be conducted in three stages. In the first stage the ideal bolus volume of ropivacaine will be determined. In the second stage the optimal rate of delivery of the bolus (infusion rate) will be determined. Finally, once both the ideal volume and infusion rate has been determined, the optimal interval between boluses of local anesthetic will be determined.
Read the detailed description
The purpose of this study is to determine the ideal delivery of local anesthetics for postoperative analgesia when using continuous interscalene peripheral nerve catheters for shoulder surgery. New technology has emerged with electronic pumps that permit intermittent mandatory boluses of local anesthetic to be delivered in addition to continuous infusions. The pump would automatically deliver a bolus at a given interval, but would otherwise be idle for a period of time. This technology could improve the efficacy of local anesthetics, and thereby improve postoperative analgesia.
Continuous peripheral nerve catheters have been shown to improve pain control in several orthopedic surgical procedures when compared to opioids. However, it is not uncommon for patients to experience breakthrough pain in spite of a functional peripheral nerve block. Many times, this breakthrough pain can be managed with a bolus of local anesthetic administered by an anesthesia provider. Until recently, the vast majority of peripheral nerve catheter infusion pumps have only had the capability of providing a constant rate of local anesthetic administration. Newer technology allows for infusion pumps to deliver intermittent mandatory boluses of local anesthetic. This technique of local anesthetic administration has previously been evaluated with popliteal nerve blocks, but to our knowledge has never been evaluated for use with interscalene nerve catheters.
Currently, data would support the idea that a bolus of local anesthetic can improve analgesia with decreased side effects compared to a continuous infusion. However, there is little data evaluating the optimal volume of bolus, the optimal speed of delivery, or the optimal interval between local anesthetic boluses.
- Conditions
- Pain
- Being tested
- Ropivacaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
Change in administration of ropivacaine. Rate, Volume and Interval of bolus altered.
| Study group | Role | What they receive |
|---|---|---|
| Volume of bolus | Experimental | Ropivacaine 0.2% volume increased or decreased by 1ml based on previous patient experience. If pain greater than or equal to 5/10 in the previous patient, the current patient will receive an increase in volume of bolus by 1ml. If pain is less than 5/10 in the previous patient the current patient will receive a decrease in volume by 1ml. Receives: Drug: Ropivacaine |
| Rate of delivery of bolus | Experimental | Ropivacaine 0.2% rate increased or decreased by 50ml/hr based on previous patient experience. If pain greater than or equal to 5/10 in the previous patient at 30 minutes, the current patient will receive an increase in rate of bolus by 50ml/hr. If the pain is less than 5/10 the rate will be decreased by 50ml/hr. Receives: Drug: Ropivacaine |
| Interval between bolus | Experimental | Ropivacaine 0.2% interval increased or decreased by 1 hour based on previous patient experience. If the previous patient received pain score of 2/10 at 2 hours then the current patient will have an interval of three hours. If the pain is greater than 2/10, the interval will be shortened by 1 hour. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Volume of Ropivacaine 0.2% bolus via interscalene catheter
Up-down sequential allocation alteration of volume to determine optimal volume of bolus
Measured: 1 day
Secondary outcomes (1)
Optimal Rate of Ropivacaine 0.2% administration bolus via interscalene cathter
Up-down sequential allocation alteration of rate to determine optimal rate of bolus
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start21 Feb 2017
- Primary completion21 Feb 2017
- Study completion21 Feb 2017
Why it stopped: Insufficient staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua R Dooley, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946268
- Sponsor's protocol ID
- Pro00072762
- Status last verified
- Oct 2018
- First submitted
- 21 Oct 2016
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- 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 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Up-down Sequential Allocation Study to Determine the Optimal Volume, Rate, and Interval of Bolus of Ropivacaine 0.2% in Interscalene Continuous Nerve Catheters for Shoulder Surgery
- ClinicalTrials.gov ID
- NCT02946268
- Acronym / sponsor ID
- Pro00072762
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 27 Oct 2016 (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.
The purpose of this study is to determine the ideal delivery of local anesthetics for pain control when using continuous interscalene peripheral nerve catheters for shoulder surgery.
The study will be conducted in three stages. In the first stage the ideal bolus volume of ropivacaine will be determined. In the second stage the optimal rate of delivery of the bolus (infusion rate) will be determined. Finally, once both the ideal volume and infusion rate has been determined, the optimal interval between boluses of local anesthetic will be determined.
Detailed description
The purpose of this study is to determine the ideal delivery of local anesthetics for postoperative analgesia when using continuous interscalene peripheral nerve catheters for shoulder surgery. New technology has emerged with electronic pumps that permit intermittent mandatory boluses of local anesthetic to be delivered in addition to continuous infusions. The pump would automatically deliver a bolus at a given interval, but would otherwise be idle for a period of time. This technology could improve the efficacy of local anesthetics, and thereby improve postoperative analgesia.
Continuous peripheral nerve catheters have been shown to improve pain control in several orthopedic surgical procedures when compared to opioids. However, it is not uncommon for patients to experience breakthrough pain in spite of a functional peripheral nerve block. Many times, this breakthrough pain can be managed with a bolus of local anesthetic administered by an anesthesia provider. Until recently, the vast majority of peripheral nerve catheter infusion pumps have only had the capability of providing a constant rate of local anesthetic administration. Newer technology allows for infusion pumps to deliver intermittent mandatory boluses of local anesthetic. This technique of local anesthetic administration has previously been evaluated with popliteal nerve blocks, but to our knowledge has never been evaluated for use with interscalene nerve catheters.
Currently, data would support the idea that a bolus of local anesthetic can improve analgesia with decreased side effects compared to a continuous infusion. However, there is little data evaluating the optimal volume of bolus, the optimal speed of delivery, or the optimal interval between local anesthetic boluses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Volume of bolus | Experimental | Drug: RopivacaineRopivacaine 0.2% volume increased or decreased by 1ml based on previous patient experience. If pain greater than or equal to 5/10 in the previous patient, the current patient will receive an increase in volume of bolus by 1ml. If pain is less than 5/10 in the previous patient the current patient will receive a decrease in volume by 1ml. |
| Rate of delivery of bolus | Experimental | Drug: RopivacaineRopivacaine 0.2% rate increased or decreased by 50ml/hr based on previous patient experience. If pain greater than or equal to 5/10 in the previous patient at 30 minutes, the current patient will receive an increase in rate of bolus by 50ml/hr. If the pain is less than 5/10 the rate will be decreased by 50ml/hr. |
| Interval between bolus | Experimental | Drug: RopivacaineRopivacaine 0.2% interval increased or decreased by 1 hour based on previous patient experience. If the previous patient received pain score of 2/10 at 2 hours then the current patient will have an interval of three hours. If the pain is greater than 2/10, the interval will be shortened by 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, ≥18 years of age
- Patients scheduled to undergo unilateral shoulder surgery at Duke University Medical Center, including arthroscopic rotator cuff repair, acromioplasty, hemiarthroplasty, and total shoulder replacement.
- American Society of Anesthesiology (ASA) Physical Class 1-3.
- BMI ≤40 kg/m2
Key exclusion criteria (10 listed)
- Patients with a contraindication to placement of interscalene nerve block. This includes abnormal clotting, skin infection involving the neck, the presence of neurological disorders or cervical spine disease, contralateral phrenic nerve dysfunction, or moderate-severe COPD (FEV1<80% of normal values and/or FEV1/FVC < 0.70)
- Patients with chronic pain (pain existing for longer than 6 months), or taking chronic opioids (greater than 60 morphine equivalents per day) at time of surgery
- Contraindications to or known drug interactions with local anesthetics
- Patients who will be discharged home directly from PACU
- Planned administration of another investigational product or procedure during the subject's participation in this study.
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: NaropinChange in administration of ropivacaine. Rate, Volume and Interval of bolus altered. | Drug | Interval between bolus, Rate of delivery of bolus, Volume of bolus |
Primary outcome
Optimal Volume of Ropivacaine 0.2% bolus via interscalene catheter
Time frame: 1 day
Up-down sequential allocation alteration of volume to determine optimal volume of bolus
1 secondary outcome
Optimal Rate of Ropivacaine 0.2% administration bolus via interscalene cathter
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- 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.
Joshua R Dooley, MD principal investigator
Duke University
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 Ropivacaine in people with Pain, run by Duke University 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 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: withdrawn, as of the sponsor's last update on 13 Nov 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Optimal Volume of Ropivacaine 0.2% bolus via interscalene catheter (time frame: 1 day). 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 13 Nov 2019.