Interscalene Brachial Plexus Catheter Versus Single-shot Interscalene Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05020821

Collaborator

(none)

Enrollment

Location

Arms

10.8

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

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. Interscalene brachial plexus block (IBPB) is a commonly employed regional anesthetic technique for shoulder arthroplasty, and a continuous catheter is often placed to extend the analgesic benefit of the block. However, continuous IBPB is more costly and time-consuming than single-shot IBPB. Recent evidence suggests that intravenous (IV) dexmedetomidine (DEX) prolong the analgesic duration after single-shot IBPB. The investigators will compare continuous IBPB with single-shot IBPB with IV DEX in patients undergoing shoulder arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Arthroplasty Postoperative Pain	Procedure: Single-shot interscalene block with intravenous dexmedetomidine Procedure: Continuous interscalene brachial plexus block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Interscalene Brachial Plexus Catheter Versus Single-shot Interscalene Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty

Actual Study Start Date :

Sep 2, 2021

Anticipated Primary Completion Date :

Jul 26, 2022

Anticipated Study Completion Date :

Jul 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single-shot interscalene block with intravenous dexmedetomidine participants receiving single-shot interscalene block with intravenous dexmedetomidine	Procedure: Single-shot interscalene block with intravenous dexmedetomidine During surgery, dexmedetomidine will be administered. After intravenous administration of 2 mcg/kg for 30 minutes, 5 mcg/kg/hr will be administered until the end of surgery. After surgery, a single-shot interscalene brachial plexus block will be performed under ultrasound guidance. 15 mL of 0.5% ropivacaine with 1:200,000 epinephrine will be administered.
Experimental: Continuous interscalene brachial plexus block participants receiving continuous interscalene brachial plexus block	Procedure: Continuous interscalene brachial plexus block Continuous interscalene 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.

Arm

Intervention/Treatment

Active Comparator: Single-shot interscalene block with intravenous dexmedetomidine

participants receiving single-shot interscalene block with intravenous dexmedetomidine

Procedure: Single-shot interscalene block with intravenous dexmedetomidine

During surgery, dexmedetomidine will be administered. After intravenous administration of 2 mcg/kg for 30 minutes, 5 mcg/kg/hr will be administered until the end of surgery. After surgery, a single-shot interscalene brachial plexus block will be performed under ultrasound guidance. 15 mL of 0.5% ropivacaine with 1:200,000 epinephrine will be administered.

Experimental: Continuous interscalene brachial plexus block

participants receiving continuous interscalene brachial plexus block

Procedure: Continuous interscalene brachial plexus block

Continuous interscalene 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.

Outcome Measures

Primary Outcome Measures

Numeric rating scale pain score [24 hours afer 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05020821

Other Study ID Numbers:

4-2021-0853

First Posted:

Aug 25, 2021

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Dexmedetomidine

Study Results

No Results Posted as of Jul 11, 2022