Ankle ArthropathyPhase 2/3NCT04022057
The Impact of a Preoperative Nerve Block in Foot and Ankle Surgery on the Consumption of Sevoflurane
A Phase 2/3 study testing Ropivacaine injection and Dextrose 5 in people with Ankle Arthropathy and Anesthesia; Functional, run by University of Alberta at 1 site in Canada.
Trial summary
Reconstructive foot and ankle surgery is performed under general anesthesia. Included in this spectrum of surgery are ankle arthroplasties, various fusions, corrective arthrodesis, and more. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Arthropathy, Anesthesia; Functional, Ankle Arthritis
- What is being tested?
- Ropivacaine injection and Dextrose 5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to 15 Mar 2020
- 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 reconstructive foot and ankle surgery
- Patients eligible for popliteal and saphenous nerve block
- All adults 18 years of age or older
- 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
1 site in 1 country.
About this study
Reconstructive foot and ankle surgery is performed under general anesthesia. Included in this spectrum of surgery are ankle arthroplasties, various fusions, corrective arthrodesis, and more. 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 with being more awake and crisp more quickly after surgery. It can also reduce cost to the system. A further benefit which has received very little attention so far, is that reducing the amount of inhaled anesthetic given also lowers the environmental footprint created by the anesthetic. For the region of the foot and ankle to be fully frozen, both the sciatic nerve and the saphenous nerve must be successfully blocked. Sciatic nerve blockade is most commonly achieved by blocking the nerve in the popliteal fossa. This block is named popliteal nerve block.
The investigators will examine and quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the nerve blocks are applied before or after surgery. Patients will have two nerve block catheters (popliteal and saphenous catheter) placed under ultrasound-guidance prior to the case by an experienced and specifically trained anesthesiologist. The catheters will be loaded with a solution to which the anesthesiologist is blinded. It will either be local anesthetic or 5% dextrose (sham). The general anesthetic will be conducted according to a research protocol with anesthetic depth being the targeted endpoint. Measurements of the required MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes by a study team member. At the end of the case the anesthesiologist will be unblinded to the solution. Should the patient have received sham initially, they will now receive the full dose of local anesthetic prior to being 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 at least 2 hours prior to surgery. Patients will then be randomized into two groups:
- Popliteal and saphenous nerve block catheter insertion with 10 mL 1% ropivacaine injection into each (Treatment group)
- Popliteal and saphenous nerve block catheter insertion with 10 mL 5% dextrose injection into each (Sham)
All syringes will be blinded to the anesthesiologist in the case. Each patient will have two syringes for before and for after surgery - one set for treatment and one sham. Depending on the randomization they will get first one before surgery and then the other after surgery. Popliteal and saphenous nerve block catheters will be inserted under ultrasound guidance using the catheter-over-needle technique whereby the location of the tip of the catheter can be easily determined. All nerve block catheters will be performed by experienced acute pain physicians who have been performing interscalene blocks under ultrasound guidance for at least 5 years. Successful catheter placement will be verified by following the spread of the injectate, which will occur just before induction of general anesthesia in the operating room. Induction of general anesthesia will follow a standardized protocol with the intravenous administration of sufentanil 0.2 mcg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. General anesthesia will be maintained with sevoflurane, which will be age-adjusted to 1.0 minimum alveolar concentration (MAC) to begin the case and then adjusted from there as per protocol. Sedline, Masimo® will be used to monitor the depth of anesthesia. The intraoperative patient state index (PSI) target will be 25 - 50. As per protocol, adjustments of the age-adjusted MAC will be performed as follows at every measuring point:
A PSI of either below 25 or of over 50 will always be treated with an adjustment of the age-adjusted MAC value. The same is done if the heart rate and/or the blood pressure is outside of +/- 20% of baseline. The primary goal is to treat any of the above changes with an adjustment to the age-adjusted MAC value. The anesthesiologist will always be able to administer an analgesic, should this be clinically necessary. The patient will be given a bolus of 1 mcg/kg of remifentanil and this will be recorded. The age-adjusted MAC value will be recorded every 5 minutes until the anesthesiologist reduces the anesthetic in preparation for extubation. At the conclusion of surgery and before general anesthesia is ended, the patients will receive the second set of solutions injected into their catheters.
Postoperatively, patients will go to post-anesthesia care unit (PACU). The distribution of the sensory or motor block will then be checked and recorded 30 minutes after arriving in PACU in both groups. The numerical rating scale (NRS) for pain will also be recorded in PACU at 0, 15, 30 and 45 minutes. The patients will there be assessed by members of the acute pain service team and treated as necessary before being transferred to the ward.
The patient, operating room anesthesiologist and the data collection personnel will be blinded.
- Conditions
- Ankle Arthropathy, Anesthesia; Functional, Ankle Arthritis
- Being tested
- Ropivacaine injection, Dextrose 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Local anesthetic injection
Dextrose 5Drug
Sham Injection
| Study group | Role | What they receive |
|---|---|---|
| Pre-GA | Active comparator | 10 mL of 1% ropivacaine injection before the start of surgery and 10 ml of 5% dextrose injection at the end of surgery through both the popliteal and the saphenous catheter Receives: Drug: Ropivacaine injection; Drug: Dextrose 5 |
| Post-GA | Sham comparator | 10 mL of 5% dextrose injection before the start of surgery and 10 ml of 1% ropivacaine injection at the end of surgery through both the popliteal and the saphenous catheter Receives: Drug: Ropivacaine injection; Drug: Dextrose 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age-adjusted MAC of sevoflurane per hour
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: Intraoperative measurement done at the end of anesthetic
Secondary outcomes (10)
Intraoperative heart rate
Intraoperative heart rate (in beats/minute) 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: Up to 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: Up to 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/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: Up to 24 postoperative hours
24 hour opioid consumption
Total consumption of opioids (in morphine equivalents) over the first 24 postoperative hours will be recorded and compared between the two groups
Measured: Up to 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
Sensory testing of nerves in the distribution of the nerve block ("Cold test")
Sensory testing of the L2-S4 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
Intraoperative Mean blood pressure
Intraoperative mean blood pressure (in mm Hg) will be documented at 5 minute interval 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 posted16 Jul 2019
- Study start1 Aug 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle ArthropathyStudies 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
- 0 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 AlbertaLora Pencheva, MD, Study director, University of AlbertaRakesh V Sondekoppam, MD, Study chair, University of AlbertaTimur JP Özelsel, MD, DESA, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022057
- Sponsor's protocol ID
- Pro00092857
- Status last verified
- Jun 2024
- First submitted
- 8 Jul 2019
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Preoperative Nerve Block in Foot and Ankle Surgery on the Consumption of Sevoflurane
- ClinicalTrials.gov ID
- NCT04022057
- Acronym / sponsor ID
- Pro00092857
- Conditions
- Ankle Arthropathy, Anesthesia; Functional, Ankle Arthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 Pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 16 Jul 2019 (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.
Reconstructive foot and ankle surgery is performed under general anesthesia. Included in this spectrum of surgery are ankle arthroplasties, various fusions, corrective arthrodesis, and more. 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 with being more awake and crisp more quickly after surgery. It can also reduce cost to the system. A further benefit which has received very little attention so far, is that reducing the amount of inhaled anesthetic given also lowers the environmental footprint created by the anesthetic. For the region of the foot and ankle to be fully frozen, both the sciatic nerve and the saphenous nerve must be successfully blocked. Sciatic nerve blockade is most commonly achieved by blocking the nerve in the popliteal fossa. This block is named popliteal nerve block.
The investigators will examine and quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the nerve blocks are applied before or after surgery. Patients will have two nerve block catheters (popliteal and saphenous catheter) placed under ultrasound-guidance prior to the case by an experienced and specifically trained anesthesiologist. The catheters will be loaded with a solution to which the anesthesiologist is blinded. It will either be local anesthetic or 5% dextrose (sham). The general anesthetic will be conducted according to a research protocol with anesthetic depth being the targeted endpoint. Measurements of the required MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes by a study team member. At the end of the case the anesthesiologist will be unblinded to the solution. Should the patient have received sham initially, they will now receive the full dose of local anesthetic prior to being woken up.
Detailed description
Following ethics approval, eligible patients meeting the inclusion/exclusion criteria will be consented in pre-assessment unit or day surgery at least 2 hours prior to surgery. Patients will then be randomized into two groups:
- Popliteal and saphenous nerve block catheter insertion with 10 mL 1% ropivacaine injection into each (Treatment group)
- Popliteal and saphenous nerve block catheter insertion with 10 mL 5% dextrose injection into each (Sham)
All syringes will be blinded to the anesthesiologist in the case. Each patient will have two syringes for before and for after surgery - one set for treatment and one sham. Depending on the randomization they will get first one before surgery and then the other after surgery. Popliteal and saphenous nerve block catheters will be inserted under ultrasound guidance using the catheter-over-needle technique whereby the location of the tip of the catheter can be easily determined. All nerve block catheters will be performed by experienced acute pain physicians who have been performing interscalene blocks under ultrasound guidance for at least 5 years. Successful catheter placement will be verified by following the spread of the injectate, which will occur just before induction of general anesthesia in the operating room. Induction of general anesthesia will follow a standardized protocol with the intravenous administration of sufentanil 0.2 mcg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. General anesthesia will be maintained with sevoflurane, which will be age-adjusted to 1.0 minimum alveolar concentration (MAC) to begin the case and then adjusted from there as per protocol. Sedline, Masimo® will be used to monitor the depth of anesthesia. The intraoperative patient state index (PSI) target will be 25 - 50. As per protocol, adjustments of the age-adjusted MAC will be performed as follows at every measuring point:
A PSI of either below 25 or of over 50 will always be treated with an adjustment of the age-adjusted MAC value. The same is done if the heart rate and/or the blood pressure is outside of +/- 20% of baseline. The primary goal is to treat any of the above changes with an adjustment to the age-adjusted MAC value. The anesthesiologist will always be able to administer an analgesic, should this be clinically necessary. The patient will be given a bolus of 1 mcg/kg of remifentanil and this will be recorded. The age-adjusted MAC value will be recorded every 5 minutes until the anesthesiologist reduces the anesthetic in preparation for extubation. At the conclusion of surgery and before general anesthesia is ended, the patients will receive the second set of solutions injected into their catheters.
Postoperatively, patients will go to post-anesthesia care unit (PACU). The distribution of the sensory or motor block will then be checked and recorded 30 minutes after arriving in PACU in both groups. The numerical rating scale (NRS) for pain will also be recorded in PACU at 0, 15, 30 and 45 minutes. The patients will there be assessed by members of the acute pain service team and treated as necessary before being transferred to the ward.
The patient, operating room anesthesiologist and the data collection personnel will be blinded.
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 injection, Drug: Dextrose 510 mL of 1% ropivacaine injection before the start of surgery and 10 ml of 5% dextrose injection at the end of surgery through both the popliteal and the saphenous catheter |
| Post-GA | Sham comparator | Drug: Ropivacaine injection, Drug: Dextrose 510 mL of 5% dextrose injection before the start of surgery and 10 ml of 1% ropivacaine injection at the end of surgery through both the popliteal and the saphenous 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 reconstructive foot and ankle surgery
- Patients eligible for popliteal and saphenous nerve block
- All adults 18 years of age or older
- 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 |
|---|---|---|
| Ropivacaine injectionLocal anesthetic injection | Drug | Post-GA, Pre-GA |
| Dextrose 5Sham Injection | Drug | Post-GA, Pre-GA |
Primary outcome
Age-adjusted MAC of sevoflurane per hour
Time frame: Intraoperative 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.
10 secondary outcomes
Intraoperative heart rate
Time frame: Intraoperative period
Intraoperative opioid use
Time frame: Intraoperative period
Postoperative opioid use in PACU
Time frame: Up to 24 postoperative hours
Maximum pain scores in the first 24 post-operative hours
Time frame: Up to 24 postoperative hours
Nausea and vomiting in the first 24 post-operative hours
Time frame: Up to 24 postoperative hours
24 hour opioid consumption
Time frame: Up to 24 postoperative hours
The sedation score in PACU
Time frame: 1st postoperative hour
Sensory testing of nerves in the distribution of the nerve block ("Cold test")
Time frame: 1st postoperative hour
Intraoperative vasopressor usage
Time frame: Intraoperative period
Intraoperative Mean blood pressure
Time frame: Intraoperative period
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 6 Jun 2024.
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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
Lora Pencheva, MD study director
University of Alberta
Rakesh V Sondekoppam, MD study chair
University of Alberta
1 site 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 injection and Dextrose 5 in people with Ankle Arthropathy and Anesthesia; Functional, run by University of Alberta at 1 site 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: withdrawn, as of the sponsor's last update on 6 Jun 2024. 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 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 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?
Age-adjusted MAC of sevoflurane per hour (time frame: Intraoperative 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 6 Jun 2024.