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

NCT05020821 | Completed DMC

• 1 other identifier: 4-2021-0853
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroplasty; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after the end of surgery

Study Arms (2)

Single-shot superior trunk block with intravenous dexmedetomidine

ACTIVE COMPARATOR

participants receiving single-shot superior trunk block with intravenous dexmedetomidine

Procedure: Single-shot superior trunk block with intravenous dexmedetomidine

Continuous superior trunk block

EXPERIMENTAL

participants receiving continuous superior trunk block

Procedure: Continuous superior trunk block

Interventions

Single-shot superior trunk block with intravenous dexmedetomidine PROCEDURE

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.

Single-shot superior trunk block with intravenous dexmedetomidine

Continuous superior trunk block PROCEDURE

During surgery, an equivalent volume of the placebo solution was administered in a similar manner as dexmedetomidine. The superior trunk block catheter will be inserted under ultrasound guidance using 15 mL of 0.5% ropivacaine after the operation 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.

Continuous superior trunk block

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: September 2, 2021
• Primary Completion: August 9, 2022
• Study Completion: August 10, 2022
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)