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The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty

Primary Purpose

Rotator Cuff Injuries, Anesthesia; Functional

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

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing elective shoulder arthroscopy
  • Patients eligible for interscalene brachial plexus 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 the interscalene catheter

10 ml of 5% dextrose injection before the start of surgery and 1% ropivacaine injection at the end of surgery through the interscalene catheter

Outcomes

Primary Outcome Measures

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.

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) 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
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
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 C5 and C6 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 10, 2019
Last Updated
May 23, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT04020601
Brief Title
The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty
Official Title
The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty
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
Total arthroplasty 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 total shoulder arthroplasty 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 10 mL 1% ropivacaine injection (Treatment group) Interscalene nerve block catheter insertion with 10 mL 5% dextrose 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 1% ropivacaine through the catheter before the start of surgery and 10 ml of 5% dextrose at the end of surgery. The patients in group POST-GA will receive 10 ml of 5% dextrose before the start of surgery and 10 ml of1% 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 +/-20% 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 20% 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 10 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 pain scores over the first 24 postoperative hours will also be collected for comparison.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries, Anesthesia; Functional

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
50 (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 the interscalene catheter
Arm Title
POST-GA
Arm Type
Sham Comparator
Arm Description
10 ml of 5% dextrose injection before the start of surgery and 1% ropivacaine injection at the end of surgery through the interscalene catheter
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Local anesthetic injection
Intervention Type
Drug
Intervention Name(s)
Dextrose
Intervention Description
Sham injection
Primary Outcome Measure Information:
Title
Average age-adjusted MAC of sevoflurane
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 measurement
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 measurement
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) 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
Time Frame
Up to 24 postoperative hours
Title
24 hour opioid consumption
Description
Frequency and 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 C5 and C6 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 identity and self-representation is eligible
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective shoulder arthroscopy Patients eligible for interscalene brachial plexus 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 on the Consumption of Sevoflurane in Total Shoulder Arthroplasty

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