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OpenTrials
Completed

NCT Number: NCT05020821

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

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.

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Key information

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Numeric rating scale pain score

    Time frame: 24 hours after the end of surgery

    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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2021
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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