Recruiting

Paracoracoid & Interscalene

Sponsor:

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

Code:

NCT03073928

Conditions

Rotator Cuff Injury

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Interscalene Block

Paracoracoid SPB

Ropivacaine

Study Details

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

Study ID

NCT03073928

Start date

Jun 15, 2017

Status verified date

Jun, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Mar, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Interscalene Block

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

experimental: Paracoracoid SPB

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.

Interventions

Interscalene Block

Regional Anesthesia procedure in the neck

Paracoracoid SPB

Regional anesthesia procedure under the collar bone

Ropivacaine

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

Primary outcome measure

  • Duration of analgesia [ Time Frame: Pain NRS measured every 120 minutes until score of 6/10 is obtained (up to 24 hours). ]

Central Contacts and Locations

Central contacts

Sugantha Ganapathy, MD, FRCPC

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

Locations

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

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Sugantha Ganapathy, FRCPC, FRCA

519-685-8500sugantha.ganapathy@lhsc.on.ca

More Information

Sponsor

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

Last update posted

Aug 28, 2017

Last verified

Jun, 2017

Keywords

  • Nerve block
  • Diaphragm function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2017-08-28.