Comparison of Paracoracoid Subscapularis Plane Block to Interscalene Block for Arthroscopic Shoulder Surgery

NCT03073928 | Unknown

• 1 other identifier: 108648
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

One hundred and twenty patients will be randomized to Interscalene block or Paracoracoid Subscapularis plane block. The study will evaluate the efficacy and duration of blocks in the 2 groups with regards to postoperative analgesia and degree of respiratory depression.

Conditions

Rotator Cuff Injury

Keywords

Nerve block; Diaphragm function

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  Duration in hours from end of injection to patient reported pain NRS score of more than 6/10

  Pain NRS measured every 120 minutes until score of 6/10 is obtained (up to 24 hours).

Secondary Outcomes (1)

• Measurement of diaphragm thickening pre and post block

  3 measurements - pre block, 20 minutes post block & 1 hour post surgery

Other Outcomes (1)

• Measurement of Forced Expiratory Volume in 1 second (FEV1)

  3 measurements - pre block, 20 minutes post block & 1 hour post surgery

Study Arms (2)

Interscalene Block

ACTIVE COMPARATOR

Receives interscalene block with 15mL of ropivacaine 0.5% at the level of C6. A total of 15mL will be injected with repeated aspirations to rule out intravascular placement of the needle tip. Once this is done, the needle tip will be moved to the lateral edge of sternocleidomastoid muscle and additional 3mL of 0.5% ropivacaine will be injected between the deep fascia of the sternocleidomastoid and deep investing fascia of the neck (superficial cervical plexus block SCP). We will administer injection of saline similar to experimental group to blind the patient

Procedure: Interscalene Block; Drug: Ropivacaine

Paracoracoid SPB

EXPERIMENTAL

Receives paracoracoid subscapularis plane block with the ultrasound. Using a 50mm 22G block needle 15ml of 0.5% Ropivacaine will be deposited anterior to the fascia of subscapularis muscle after eliciting a motor response with 0.6mA current delivered through the needle. Following this, superficial cervical plexus block will be done using 3mL of 0.5% ropivacaine similar to group 1.

Procedure: Paracoracoid SPB; Drug: Ropivacaine

Interventions

Interscalene Block PROCEDURE

Regional Anesthesia procedure in the neck

Interscalene Block

Paracoracoid SPB PROCEDURE

Regional anesthesia procedure under the collar bone

Paracoracoid SPB

Ropivacaine DRUG

Amide local anesthetic Ropivacaine will be used in same concentration (milligrams) in both active comparator and experimental group

Interscalene Block; Paracoracoid SPB

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females of 16-85years of age, scheduled to undergo arthroscopic shoulder surgery.
• Elective shoulder surgery undergoing general anesthesia in combination with regional blockade.
• ASA Class I,II and III
• Able to give informed consent
• Able to cooperate with study process
• Availability of home telephone

You may not qualify if:

• ASA 4
• Refusal to have regional block
• Lack of informed consent.
• Language or reading barrier
• Allergy to any of the drugs used in the study.
• Patients with associated significant cardiac and respiratory disease.
• Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
• Patients with coexisting hematological disorder or with deranged coagulation parameters.
• Significant psychiatric illnesses. (Schizophrenia or bipolar disorders, uncontrolled anxiety or depression)
• Narcotic dependency (Chronic opioid use of greater than 15 mg oral morphine equivalents daily)
• Peripheral neuropathy
• Pregnancy
• Emergency surgery

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre, St. Joseph's Heath Care

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (1)

• Sondekoppam RV, Lopera-Velasquez LM, Naik L, Ganapathy S. Subscapularis and sub-omohyoid plane blocks: an alternative to peripheral nerve blocks for shoulder analgesia. Br J Anaesth. 2016 Dec;117(6):831-832. doi: 10.1093/bja/aew370. No abstract available.

  PMID: 27956687 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sugantha Ganapathy, MD, FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sugantha Ganapathy, MD, FRCPC

CONTACT

1-519-685-8500; sganapat@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: March 8, 2017
• Study Start: June 15, 2017
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)