Post-operative PainNCT00672100
Initial Local Anesthetic Dose With Continuous Interscalene Analgesia
A study testing Ropivacaine in people with Post-operative Pain, run by Corewell Health East at 2 sites in United States.
Trial summary
Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Aug 2010
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to participation in the study.
- Is scheduled to undergo Arthroscopic Rotator Cuff Repair, defined as arthroscopically assisted repair of any of the muscles or tendons comprising the rotator cuff.
- If subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery per standard of care
- Be at least 18, but not more than 80 years of age
- Have an ASA risk class of I, II, or III according to the American Society of Anesthesiologists (ASA).
- Have the ability to read and understand the study procedures and the use of the pain scales. Must have the ability to communicate meaningfully with the Study Investigator and staff.
- Be free of other physical, mental, or medical conditions, which in the opinion of the Investigator, makes study participation inadvisable.
Who cannot join
- Subjects requiring daily opioids equivalent to greater than 40 mg oxycodone for over 2 weeks prior to the study.
- Has significant preexisting pulmonary (respiratory/breathing) disease, diaphragmatic paralysis or history of phrenic nerve injury (problems with the diaphragm causing breathing difficulties).
- Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
- Has known significant hypersensitivity to opioids, Ropivacaine, or the inactive ingredients (excipients) of the study medications.
- Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years.
- Has clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) based on medical history and examination.
- Has participated in another clinical Study (investigational or marketed product within 30 days of surgery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
William Beaumont Hospital
Royal Oak, Michigan, 48073
William Beaumont Hospitals
Troy, Michigan, 48085
About this study
Official title: The Effect Of Initial Local Anesthetic Dose With Continuous Interscalene Analgesia On Postoperative Pain And Diaphragmatic Function In Arthroscopic Shoulder Surgery Patients: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study
Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.
Read the detailed description
Aims:
- To compare pain ratings and supplemental analgesic requirements at discharge from PACU, 24 hours, and 48 hours and 12 weeks following 5, 10, and 20 ml boluses.
- To compare adverse events including clinical dysphonia, Horner's syndrome, dyspnea, unexpected hospitalization, evidence of local anesthetic toxicity, and hand weakness at discharge from PACU following 5, 10, and 20 ml boluses.
- To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10, and 20 ml boluses.
- To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and 20 ml boluses.
- To compare patient rating of functional outcome at baseline and at 12 weeks following 5, 10, and 20 ml boluses.
- To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses.
- Conditions
- Post-operative Pain
- Being tested
- Ropivacaine
- Keywords
- Peripheral Nerve Infusion,, continuous brachial plexus block,, post-operative pain, diaphragmatic paresis
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Initial Bolus 5 ml Ropivacaine via interscalene injection
RopivacaineDrug
Initial Bolus 10 ml Ropivacaine via interscalene injection
RopivacaineDrug
Initial Bolus 20 ml Ropivacaine via interscalene injection
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Initial Bolus 5 ml Ropivacaine Receives: Drug: Ropivacaine |
| B | Active comparator | Initial Bolus 10 ml Ropivacaine Receives: Drug: Ropivacaine |
| C | Active comparator | Initial Bolus 20 ml Ropivacaine Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measurements Via Numeric Pain Rating Scales (NRS)
Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: Discharge, 24 h, 48h, 12 weeks
Change in Diaphragmatic Displacement From Baseline to Post-surgery
Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.
Measured: Baseline, Post anesthesia care unit (PACU) - within 8 hours
Secondary outcomes (2)
Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful"
Participants were asked to rate the helpfulness of their infusion:
- extremely harmful
- harmful
- neutral
- not harmful, but not helpful
- helpful
- extremely helpful
Measured: at 24 and 48 hours after discharge from the hospital
Functional Outcome - Simple Shoulder Test (SST)
At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2010
- Study completionAug 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Beaumont Foundation of America
- Responsible party
- Sponsor
- Investigators
- Craig Hartrick, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672100
- Sponsor's protocol ID
- HIC 2007-198
- Status last verified
- May 2013
- First submitted
- 2 May 2008
- Last updated
- 7 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hartrick CT, Tang YS, Siwek D, Murray R, Hunstad D, Smith G. The effect of initial local anesthetic dose with continuous interscalene analgesia on postoperative pain and diaphragmatic function in patients undergoing arthroscopic shoulder surgery: a double-blind, randomized controlled trial. BMC Anesthesiol. 2012 Mar 23;12:6. doi: 10.1186/1471-2253-12-6.
PubMed 22443231
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Initial Local Anesthetic Dose With Continuous Interscalene Analgesia On Postoperative Pain And Diaphragmatic Function In Arthroscopic Shoulder Surgery Patients: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study
- ClinicalTrials.gov ID
- NCT00672100
- Acronym / sponsor ID
- HIC 2007-198
- Conditions
- Post-operative Pain
- Keywords
- Peripheral Nerve Infusion,, continuous brachial plexus block,, post-operative pain, diaphragmatic paresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Beaumont Foundation of America
- Study start
- Jan 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Posted 23 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.
Detailed description
Aims:
- To compare pain ratings and supplemental analgesic requirements at discharge from PACU, 24 hours, and 48 hours and 12 weeks following 5, 10, and 20 ml boluses.
- To compare adverse events including clinical dysphonia, Horner's syndrome, dyspnea, unexpected hospitalization, evidence of local anesthetic toxicity, and hand weakness at discharge from PACU following 5, 10, and 20 ml boluses.
- To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10, and 20 ml boluses.
- To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and 20 ml boluses.
- To compare patient rating of functional outcome at baseline and at 12 weeks following 5, 10, and 20 ml boluses.
- To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: RopivacaineInitial Bolus 5 ml Ropivacaine |
| B | Active comparator | Drug: RopivacaineInitial Bolus 10 ml Ropivacaine |
| C | Active comparator | Drug: RopivacaineInitial Bolus 20 ml Ropivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide written informed consent prior to participation in the study.
- Is scheduled to undergo Arthroscopic Rotator Cuff Repair, defined as arthroscopically assisted repair of any of the muscles or tendons comprising the rotator cuff.
- If subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery per standard of care
- Be at least 18, but not more than 80 years of age
- Have an ASA risk class of I, II, or III according to the American Society of Anesthesiologists (ASA).
Key exclusion criteria (7 listed)
- Subjects requiring daily opioids equivalent to greater than 40 mg oxycodone for over 2 weeks prior to the study.
- Has significant preexisting pulmonary (respiratory/breathing) disease, diaphragmatic paralysis or history of phrenic nerve injury (problems with the diaphragm causing breathing difficulties).
- Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
- Has known significant hypersensitivity to opioids, Ropivacaine, or the inactive ingredients (excipients) of the study medications.
- Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years.
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 |
|---|---|---|
| RopivacaineInitial Bolus 5 ml Ropivacaine via interscalene injection | Drug | A |
| RopivacaineInitial Bolus 10 ml Ropivacaine via interscalene injection | Drug | B |
| RopivacaineInitial Bolus 20 ml Ropivacaine via interscalene injection | Drug | C |
Primary outcome
Pain Measurements Via Numeric Pain Rating Scales (NRS)
Time frame: Discharge, 24 h, 48h, 12 weeks
Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)
Change in Diaphragmatic Displacement From Baseline to Post-surgery
Time frame: Baseline, Post anesthesia care unit (PACU) - within 8 hours
Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.
2 secondary outcomes
Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful"
Time frame: at 24 and 48 hours after discharge from the hospital
Functional Outcome - Simple Shoulder Test (SST)
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22443231Hartrick CT, Tang YS, Siwek D, Murray R, Hunstad D, Smith G. The effect of initial local anesthetic dose with continuous interscalene analgesia on postoperative pain and diaphragmatic function in patients undergoing arthroscopic shoulder surgery: a double-blind, randomized controlled trial. BMC Anesthesiol. 2012 Mar 23;12:6. doi: 10.1186/1471-2253-12-6.
Related trials for Post-operative Pain
Not yet recruitingObservational study
Impact of Parasternal and Rectointercostal Blocks on Extubation Time
Postoperative Pain, Extubation Time
RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
Craig Hartrick, MD principal investigator
Corewell Health East
2 sites 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 Post-operative Pain, run by Corewell Health East at 2 sites 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 7 inclusion and 7 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 23 May 2013). 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?
Pain Measurements Via Numeric Pain Rating Scales (NRS) (time frame: Discharge, 24 h, 48h, 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00672100, 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 7 Mar 2017.