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Superior Trunk Block Catheter Versus Single-shot Superior Trunk Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty

Primary Purpose

Shoulder Arthroplasty, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single-shot superior trunk block with intravenous dexmedetomidine
Continuous superior trunk block
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Shoulder Arthroplasty

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1 Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective shoulder arthroplasty

Exclusion Criteria:

  1. Allergy or intolerance to any of the drugs used in the study
  2. Heart failure
  3. Hepatic or renal insufficiency
  4. Opioid dependency
  5. Coagulopathy
  6. Pre-existing neurologic or anatomic deficits in the upper extremities
  7. Severe psychiatric illness

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single-shot superior trunk block with intravenous dexmedetomidine

Continuous superior trunk block

Arm Description

participants receiving single-shot superior trunk block with intravenous dexmedetomidine

participants receiving continuous superior trunk block

Outcomes

Primary Outcome Measures

Numeric rating scale pain score
Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 24 hours after the surgery.

Secondary Outcome Measures

Full Information

First Posted
August 18, 2021
Last Updated
June 9, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05020821
Brief Title
Superior Trunk Block Catheter Versus Single-shot Superior Trunk Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty
Official Title
Superior Trunk Block Catheter Versus Single-shot Superior Trunk Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Shoulder arthroplasty is associated with significant postoperative pain. Appropriate pain control after shoulder arthroplasty is crucial for postoperative rehabilitation and patient satisfaction. Superior trunk block is a commonly employed regional anesthetic technique for shouler arthroplasty, and a continuous catheter is often placed to extend the analgesic benefit of the block. However, continuous peripheral nervel block (PNB) is more costly and time-consuming than sigle-shot PNB. Recent evidence suggests that intravenous (IV) dexmedetomidine (DEX) prolong the analgesic duration after sigle-shot PNB. The investigators will compare continuous superior trunk block with single-shot superior trunk block with IV DEX in patients undergoing shoulder arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthroplasty, Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-shot superior trunk block with intravenous dexmedetomidine
Arm Type
Active Comparator
Arm Description
participants receiving single-shot superior trunk block with intravenous dexmedetomidine
Arm Title
Continuous superior trunk block
Arm Type
Experimental
Arm Description
participants receiving continuous superior trunk block
Intervention Type
Procedure
Intervention Name(s)
Single-shot superior trunk block with intravenous dexmedetomidine
Intervention Description
During surgery, dexmedetomidine will be administered. After intravenous administration of 2 mcg/kg for 30 minutes, 0.5 mcg/kg/hr will be administered until the end of surgery. After surgery, a single-shot superior trunk block will be performed under ultrasound guidance. 15 mL of 0.5% ropivacaine with 1:200,000 epinephrine will be administered.
Intervention Type
Procedure
Intervention Name(s)
Continuous superior trunk block
Intervention Description
Continuous superior trunk block will be performed under ultrasound guidance and utilize patient-controlled analgesia infusion pump with a 300 mL reservoir of ropivacaine 0.2%, and programmed the pump to deliver 5 mL per hour with an optional patient-controlled analgesia bolus of 4 mL at 30-minute lockout intervals. Patients were typically discharged home on POD 1, and block was continued until reservoir completion.
Primary Outcome Measure Information:
Title
Numeric rating scale pain score
Description
Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 24 hours after the surgery.
Time Frame
24 hours afer the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1 Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective shoulder arthroplasty Exclusion Criteria: Allergy or intolerance to any of the drugs used in the study Heart failure Hepatic or renal insufficiency Opioid dependency Coagulopathy Pre-existing neurologic or anatomic deficits in the upper extremities Severe psychiatric illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaewon Jang
Phone
82-2-2224-1637
Email
jaewonjang2020@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaewon Jang
Phone
82-2-2224-1637
Email
jaewonjang2020@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Superior Trunk Block Catheter Versus Single-shot Superior Trunk Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty

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