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The Impact of a Preoperative Nerve Block in Foot and Ankle Surgery on the Consumption of Sevoflurane

Primary Purpose

Ankle Arthropathy, Anesthesia; Functional, Ankle Arthritis

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Ropivacaine injection
Dextrose 5
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Arthropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Alberta HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Pre-GA

Post-GA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intraoperative heart rate
Intraoperative heart rate (in beats/minute) will be documented at 5 minute interval and compared between the two groups
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
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
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
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
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
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
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
Intraoperative vasopressor usage
Amount and frequency of the intraoperative usage of vasopressor (phenylephrine in micrograms) will be documented and compared between the two groups
Intraoperative Mean blood pressure
Intraoperative mean blood pressure (in mm Hg) will be documented at 5 minute interval and compared between the two groups

Full Information

First Posted
July 8, 2019
Last Updated
May 23, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT04022057
Brief Title
The Impact of a Preoperative Nerve Block in Foot and Ankle Surgery on the Consumption of Sevoflurane
Official Title
The Impact of a Preoperative Nerve Block in Foot and Ankle Surgery on the Consumption of Sevoflurane
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Arthropathy, Anesthesia; Functional, Ankle Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Double-blinded, randomized controlled, prospective
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-GA
Arm Type
Active Comparator
Arm Description
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
Arm Title
Post-GA
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
Local anesthetic injection
Intervention Type
Drug
Intervention Name(s)
Dextrose 5
Intervention Description
Sham Injection
Primary Outcome Measure Information:
Title
Age-adjusted MAC of sevoflurane per hour
Description
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.
Time Frame
Intraoperative measurement done at the end of anesthetic
Secondary Outcome Measure Information:
Title
Intraoperative heart rate
Description
Intraoperative heart rate (in beats/minute) will be documented at 5 minute interval and compared between the two groups
Time Frame
Intraoperative period
Title
Intraoperative opioid use
Description
Intraoperative use of short acting opioid (in microgram/Kg) as per the study protocol will be recorded and compared between the two groups
Time Frame
Intraoperative period
Title
Postoperative opioid use in PACU
Description
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
Time Frame
Up to 24 postoperative hours
Title
Maximum pain scores in the first 24 post-operative hours
Description
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
Time Frame
Up to 24 postoperative hours
Title
Nausea and vomiting in the first 24 post-operative hours
Description
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
Time Frame
Up to 24 postoperative hours
Title
24 hour opioid consumption
Description
Total consumption of opioids (in morphine equivalents) over the first 24 postoperative hours will be recorded and compared between the two groups
Time Frame
Up to 24 postoperative hours
Title
The sedation score in PACU
Description
Sedation scores will be recorded at 15 minute intervals based on Ramsay sedation scale (1-6) and will be compared between the two groups
Time Frame
1st postoperative hour
Title
Sensory testing of nerves in the distribution of the nerve block ("Cold test")
Description
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
Time Frame
1st postoperative hour
Title
Intraoperative vasopressor usage
Description
Amount and frequency of the intraoperative usage of vasopressor (phenylephrine in micrograms) will be documented and compared between the two groups
Time Frame
Intraoperative period
Title
Intraoperative Mean blood pressure
Description
Intraoperative mean blood pressure (in mm Hg) will be documented at 5 minute interval and compared between the two groups
Time Frame
Intraoperative period

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
All gender identification and self-representation is accepted
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timur JP Özelsel, MD, DESA
Phone
780-407-8861
Email
ozelsel@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rakesh V Sondekoppam, MD
Phone
780-407-8861
Email
rakesh6282@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian HY Ip, MD
Organizational Affiliation
University of Alberta
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lora Pencheva, MD
Organizational Affiliation
University of Alberta
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rakesh V Sondekoppam, MD
Organizational Affiliation
University of Alberta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Timur JP Özelsel, MD, DESA
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2G3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timur JP Özelsel, MD
Phone
780-407-8861
Email
ozelsel@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Rakesh V Sondekoppam, MD
Phone
780-407-8861
Email
rakesh6282@gmail.com
First Name & Middle Initial & Last Name & Degree
Timur JP Özelsel, MD

12. IPD Sharing Statement

Learn more about this trial

The Impact of a Preoperative Nerve Block in Foot and Ankle Surgery on the Consumption of Sevoflurane

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