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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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.

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 groups in NCT03533452
Study groupRoleWhat they receive
PRE-GAActive comparator10 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-GASham comparator10 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted23 May 2018
  2. Study start1 May 2019
  3. Primary completion1 Jan 2022
  4. Study completion1 Jan 2022

Resources

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)
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

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.

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