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

NCT04020601 | Terminated Phase 2

• 1 other identifier: Pro00092897
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injuries; Anesthesia; Functional

Outcome Measures

Primary Outcomes (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.

  Intraoperative measurement done at the end of anesthetic

Secondary Outcomes (10)

• Intraoperative heart rate

  Intraoperative measurement

• Intraoperative opioid use

  Intraoperative measurement

• Postoperative opioid use in PACU

  Up to 24 postoperative hours

• Maximum pain scores in the first 24 post-operative hours

  Up to 24 postoperative hours

• Nausea and vomiting in the first 24 post-operative hours

  Up to 24 postoperative hours

Study Arms (2)

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 the interscalene catheter

Drug: Ropivacaine; Drug: Dextrose

POST-GA

SHAM COMPARATOR

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

Drug: Ropivacaine; Drug: Dextrose

Interventions

Ropivacaine DRUG

Local anesthetic injection

POST-GA; PRE-GA

Dextrose DRUG

Sham injection

POST-GA; PRE-GA

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All gender identity and self-representation is eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective shoulder arthroscopy
• Patients eligible for interscalene brachial plexus block
• All adults 18 years of age or older
• Capable to give consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G2G3, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Ropivacaine; Glucose

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Vivian HY Ip, MD

  University of Alberta

  STUDY DIRECTOR

• Lora Pencheva, MD

  University of Alberta

  STUDY DIRECTOR

• Rakesh V Sondekoppam, MD

  University of Alberta

  STUDY CHAIR

• Timur JP Özelsel, MD, DESA

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded, randomized controlled, prospective

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 16, 2019
• Study Start: August 1, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

CA (1)