Rotator Cuff InjuryPhase 2/3NCT03533452
The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane
A Phase 2/3 study testing Ropivacaine and Normal saline in people with Rotator Cuff Injury and Anesthesia; Functional, run by University of Alberta at 2 sites in Canada.
Trial summary
Arthroscopic rotator cuff surgery of the shoulder is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Injury, Anesthesia; Functional
- What is being tested?
- Ropivacaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesCanada
- Study dates
- 1 May 2019to 1 Jan 2022
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective shoulder arthroscopy
- Patients eligible for interscalene brachial plexus block
- All adults > 18 years of age
- Capable to give consent
Who cannot join
- Patients who are unable to give consent
- Local anaesthetic allergy
- Hemidiaphragm paresis on the contralateral side to the block/surgery site
- Bleeding diathesis
- Coagulopathy
- Pre-existing neurological deficits
- Patients with a Body Mass Index >35
- Patients with significant comorbidities, physiological limitations, and allergies that are unable to tolerate the protocolized induction and maintenance of anesthesia.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta, T6G2G3
Sturgeon Community Hospital
St. Albert, Alberta, T8N6C4
About this study
Arthroscopic rotator cuff surgery of the shoulder is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient by minimizing the opioid usage after surgery and also reduce cost to the system in terms of duration of hospital stay. The purpose of the study is to investigate whether the inclusion of a nerve block to the general anesthetic for rotator cuff repair surgery will also reduce the amount of inhaled anesthetic and thereby lowering the environmental footprint from the anesthetic.
The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the nerve block is applied before or after surgery. Patients will have a nerve block catheter (interscalene catheter) placed under ultrasound-guidance prior to the induction of general anesthetic by an experienced regional anesthesiologist. The nerve block catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or normal saline (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and the total amount of volatile anesthetic (in ml and ml/kg) will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a saline (sham) or local anesthetic before the patient is woken up.
Read the detailed description
Following ethics approval, eligible patients meeting the inclusion/exclusion criteria will be consented in pre-assessment unit or day surgery ward at least 2 hours prior to their surgery. Patients will then be randomized into two groups:
Interscalene nerve block catheter insertion with 20 mL 0.5% ropivacaine injection (Treatment group) Interscalene nerve block catheter insertion with 20 mL normal saline injection (Sham group)
The patient, anesthesia provider, data recorder, OR staff and Post Anaesthetic Care Unit (PACU) nurses, will be blinded at the beginning of the case. The patients consenting for the study and meeting the eligibility criteria for the study will be randomized to either group-1 (PRE-GA) or group-2 (POST-GA) . Prior to induction of general anesthesia, all patients will receive an interscalene nerve block catheter (Pajunk e-cath) inserted under ultrasound guidance using the catheter-over-needle technique by an acute pain physician who has been performing interscalene blocks under ultrasound guidance for at least 5 years. Successful catheter placement will be verified by ultrasound visualization of the injectate spread. Based on the randomization, each patient will receive a clear 10 mL syringe containing either the Treatment or the Sham solution. Patients in group PRE-GA will receive 10 ml of 0.5% ropivacaine through the catheter before the start of surgery and 10 ml of saline (0.9%) at the end of surgery. The patients in group POST-GA will receive 10 ml of saline (0.9%) before the start of surgery and 10 ml of 0.5% ropivacaine at the end of surgery. All study medications will be prepared by the principal investigator who will be unblinded to the patient allocation. All other team members will be blinded to the group allocation.
Following the interscalene nerve block catheter insertion, all patients will receive general anesthesia with a standardized protocol using intravenous administration of fentanyl (2 mcg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg). General anesthesia will initially be maintained with sevoflurane at 1.0 age-adjusted Minimal Alveolar Concentration (MAC). Subsequently, the age-adjusted MAC will be titrated to achieve an intraoperative PSI target of 25-50 (Sedline, Masimo®), and intraoperative heart rate (HR) and mean blood pressure (MBP) target of +/-30% baseline values. The anaesthesiologist will have the ability to administer IV boluses of analgesic (remifentanil 0.5mcg/kg) if the Patient State Index (PSI) is >50 and/or the MBP or HR is above 30% of baseline. Vasopressors such as phenylephrine (100 mcg IV bolus) and ephedrine (5 mg IV bolus) can be used as last-line therapy to treat hypotension that is unresponsive to MAC adjustments. The age-adjusted MAC value will be recorded every 5 minutes starting at the time of skin incision until the time of skin closure. In addition, intraoperative analgesic and vasopressor usage are recorded. After the conclusion of MAC recording and prior to emergence from general anesthesia, the anaesthesiologist will be unblinded to the randomized groups, and the patients who received Sham solution will be given 20 mL of the treatment solution via the interscalene catheter to ensure patients receive adequate analgesia postoperatively.
Postoperatively, patients will be transferred to recovery area where the distribution of the sensory or motor block will then be checked and recorded 30 minutes after arriving in PACU to document the success of the block in both groups by the nurses blinded to the group allocation. The Visual Analogue Pain Scale for pain will also be recorded in PACU at 0, 15, 30 and 45 minutes. Postoperative opioid consumption, nausea and vomiting scores and pan scores over the first 24 postoperative hours will also be collected for comparison.
- Conditions
- Rotator Cuff Injury, Anesthesia; Functional
- Being tested
- Ropivacaine, Normal saline
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Local anesthetic injection
Normal salineDrug
Sham injection
| Study group | Role | What they receive |
|---|---|---|
| PRE-GA | Active comparator | 10 mL of 0.5% ropivacaine injection before the start of surgery and 10 ml of normal saline (0.9%) injection at the end of surgery through the interscalene catheter Receives: Drug: Ropivacaine; Drug: Normal saline |
| POST-GA | Sham comparator | 10 ml of normal saline (0.9%) injection before the start of surgery and 0.5% ropivacaine injection at the end of surgery through the interscalene catheter Receives: Drug: Ropivacaine; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average age-adjusted MAC of sevoflurane
The average age-adjusted end- tidal minimum alveolar concentration (MAC) will be calculated by averaging the end tidal MAC required to maintain the depth of anesthesia as measured by PSI between 25-50 intra-operatively. This will be compared between the two groups.
Measured: Intra-operative measurement done at the end of anesthetic
Secondary outcomes (11)
Sevoflurane consumption in ml/hr
Total amount of Sevoflurane consumed during the intraoperative period will be measured and compared between the two groups
Measured: Intra-operative - measurement done at the end of anesthetic
Sevoflurane consumption in ml//kg/hr
Total amount of Sevoflurane consumed/kg of patient body weight during the intraoperative period will be measured and compared between the two groups
Measured: Intra-operative - measurement done at the end of anesthetic
Intraoperative hemodynamics
Intraoperative heart rate (in beats/minute), systolic, diastolic and mean blood pressure (in mm Hg) will be documented at 5 minute interval and compared between the two groups
Measured: Intraoperative period
Intraoperative opioid use
Intraoperative use of short acting opioid (in microgram/Kg) as per the study protocol will be recorded and compared between the two groups
Measured: Intraoperative period
Postoperative opioid use in PACU
Total amount of opioids (in mg of morphine equivalents) in the PACU and over the first 24 postoperative hours will be recorded and compared between the two groups
Measured: 24 postoperative hours
Maximum pain scores in the first 24 post-operative hours
Maximum pain scores will be recorded using numerical rating scale (NRS) of 0-10 (where 0=no pain and 10= maximum pain) on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and compared between the two groups
Measured: 24 postoperative hours
Nausea and vomiting in the first 24 post-operative hours
Nausea scores (on a Likert scale of 1-4 where 1 = no nausea, 2= mild nausea, 3= moderate nausea and 4= severe nausea) and incidence of vomiting will be recorded on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and will be compared between the two groups
Measured: 24 postoperative hours
24 hour opioid consumption
Frequency and total consumption of opioids (in morphine equivalents) over the first 24 postoperative hours will be recorded and compared between the two groups
Measured: 24 postoperative hours
The sedation score in PACU
Sedation scores will be recorded at 15 minute intervals based on Ramsay sedation scale (1-6) and will be compared between the two groups
Measured: 1st postoperative hour
Block success
Sensory testing of the C5 and C6 dermatomes will be performed in the PACU at 30 minutes of arrival to PACU to document the success of the block
Measured: 1st postoperative hour
Intraoperative vasopressor usage
Amount and frequency of the intraoperative usage of vasopressor (phenylephrine in micrograms) will be documented and compared between the two groups
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 May 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuryStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded, randomized controlled, prospective
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian HY Ip, MD, Study director, University of AlbertaTimur JP Özelsel, MD, Principal investigator, University of AlbertaRakesh V Sondekoppam, MD, Study chair, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533452
- Sponsor's protocol ID
- Pro00079587
- Status last verified
- May 2022
- First submitted
- 9 Apr 2018
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane
- ClinicalTrials.gov ID
- NCT03533452
- Acronym / sponsor ID
- Pro00079587
- Conditions
- Rotator Cuff Injury, Anesthesia; Functional
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 23 May 2018 (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.
Arthroscopic rotator cuff surgery of the shoulder is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient by minimizing the opioid usage after surgery and also reduce cost to the system in terms of duration of hospital stay. The purpose of the study is to investigate whether the inclusion of a nerve block to the general anesthetic for rotator cuff repair surgery will also reduce the amount of inhaled anesthetic and thereby lowering the environmental footprint from the anesthetic.
The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the nerve block is applied before or after surgery. Patients will have a nerve block catheter (interscalene catheter) placed under ultrasound-guidance prior to the induction of general anesthetic by an experienced regional anesthesiologist. The nerve block catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or normal saline (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and the total amount of volatile anesthetic (in ml and ml/kg) will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a saline (sham) or local anesthetic before the patient is woken up.
Detailed description
Following ethics approval, eligible patients meeting the inclusion/exclusion criteria will be consented in pre-assessment unit or day surgery ward at least 2 hours prior to their surgery. Patients will then be randomized into two groups:
Interscalene nerve block catheter insertion with 20 mL 0.5% ropivacaine injection (Treatment group) Interscalene nerve block catheter insertion with 20 mL normal saline injection (Sham group)
The patient, anesthesia provider, data recorder, OR staff and Post Anaesthetic Care Unit (PACU) nurses, will be blinded at the beginning of the case. The patients consenting for the study and meeting the eligibility criteria for the study will be randomized to either group-1 (PRE-GA) or group-2 (POST-GA) . Prior to induction of general anesthesia, all patients will receive an interscalene nerve block catheter (Pajunk e-cath) inserted under ultrasound guidance using the catheter-over-needle technique by an acute pain physician who has been performing interscalene blocks under ultrasound guidance for at least 5 years. Successful catheter placement will be verified by ultrasound visualization of the injectate spread. Based on the randomization, each patient will receive a clear 10 mL syringe containing either the Treatment or the Sham solution. Patients in group PRE-GA will receive 10 ml of 0.5% ropivacaine through the catheter before the start of surgery and 10 ml of saline (0.9%) at the end of surgery. The patients in group POST-GA will receive 10 ml of saline (0.9%) before the start of surgery and 10 ml of 0.5% ropivacaine at the end of surgery. All study medications will be prepared by the principal investigator who will be unblinded to the patient allocation. All other team members will be blinded to the group allocation.
Following the interscalene nerve block catheter insertion, all patients will receive general anesthesia with a standardized protocol using intravenous administration of fentanyl (2 mcg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg). General anesthesia will initially be maintained with sevoflurane at 1.0 age-adjusted Minimal Alveolar Concentration (MAC). Subsequently, the age-adjusted MAC will be titrated to achieve an intraoperative PSI target of 25-50 (Sedline, Masimo®), and intraoperative heart rate (HR) and mean blood pressure (MBP) target of +/-30% baseline values. The anaesthesiologist will have the ability to administer IV boluses of analgesic (remifentanil 0.5mcg/kg) if the Patient State Index (PSI) is >50 and/or the MBP or HR is above 30% of baseline. Vasopressors such as phenylephrine (100 mcg IV bolus) and ephedrine (5 mg IV bolus) can be used as last-line therapy to treat hypotension that is unresponsive to MAC adjustments. The age-adjusted MAC value will be recorded every 5 minutes starting at the time of skin incision until the time of skin closure. In addition, intraoperative analgesic and vasopressor usage are recorded. After the conclusion of MAC recording and prior to emergence from general anesthesia, the anaesthesiologist will be unblinded to the randomized groups, and the patients who received Sham solution will be given 20 mL of the treatment solution via the interscalene catheter to ensure patients receive adequate analgesia postoperatively.
Postoperatively, patients will be transferred to recovery area where the distribution of the sensory or motor block will then be checked and recorded 30 minutes after arriving in PACU to document the success of the block in both groups by the nurses blinded to the group allocation. The Visual Analogue Pain Scale for pain will also be recorded in PACU at 0, 15, 30 and 45 minutes. Postoperative opioid consumption, nausea and vomiting scores and pan scores over the first 24 postoperative hours will also be collected for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blinded, randomized controlled, prospective
| Arm | Type | Receives |
|---|---|---|
| PRE-GA | Active comparator | Drug: Ropivacaine, Drug: Normal saline10 mL of 0.5% ropivacaine injection before the start of surgery and 10 ml of normal saline (0.9%) injection at the end of surgery through the interscalene catheter |
| POST-GA | Sham comparator | Drug: Ropivacaine, Drug: Normal saline10 ml of normal saline (0.9%) injection before the start of surgery and 0.5% ropivacaine injection at the end of surgery through the interscalene catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing elective shoulder arthroscopy
- Patients eligible for interscalene brachial plexus block
- All adults > 18 years of age
- Capable to give consent
Key exclusion criteria (8 listed)
- Patients who are unable to give consent
- Local anaesthetic allergy
- Hemidiaphragm paresis on the contralateral side to the block/surgery site
- Bleeding diathesis
- Coagulopathy
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 |
|---|---|---|
| RopivacaineLocal anesthetic injection | Drug | POST-GA, PRE-GA |
| Normal salineSham injection | Drug | POST-GA, PRE-GA |
Primary outcome
Average age-adjusted MAC of sevoflurane
Time frame: Intra-operative measurement done at the end of anesthetic
The average age-adjusted end- tidal minimum alveolar concentration (MAC) will be calculated by averaging the end tidal MAC required to maintain the depth of anesthesia as measured by PSI between 25-50 intra-operatively. This will be compared between the two groups.
11 secondary outcomes
Sevoflurane consumption in ml/hr
Time frame: Intra-operative - measurement done at the end of anesthetic
Sevoflurane consumption in ml//kg/hr
Time frame: Intra-operative - measurement done at the end of anesthetic
Intraoperative hemodynamics
Time frame: Intraoperative period
Intraoperative opioid use
Time frame: Intraoperative period
Postoperative opioid use in PACU
Time frame: 24 postoperative hours
Maximum pain scores in the first 24 post-operative hours
Time frame: 24 postoperative hours
Nausea and vomiting in the first 24 post-operative hours
Time frame: 24 postoperative hours
24 hour opioid consumption
Time frame: 24 postoperative hours
The sedation score in PACU
Time frame: 1st postoperative hour
Block success
Time frame: 1st postoperative hour
Intraoperative vasopressor usage
Time frame: Intraoperative period
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 24 May 2022.
- 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.
Vivian HY Ip, MD study director
University of Alberta
Timur JP Özelsel, MD principal investigator
University of Alberta
Rakesh V Sondekoppam, MD study chair
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ropivacaine and Normal saline in people with Rotator Cuff Injury and Anesthesia; Functional, run by University of Alberta at 2 sites in Canada.
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 8 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 24 May 2022. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Average age-adjusted MAC of sevoflurane (time frame: Intra-operative measurement done at the end of anesthetic). 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 24 May 2022.