NCT05451550

Brief Summary

Controlled hypotension is one of the important techniques used for facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. To test the hypothesis that, during arthroscopic shoulder surgery, general anesthesia combined with nerve block could provide more stable hemodynamic index than general anesthesia. Patients undergoing arthroscopic shoulder surgery were enrolled and divided into 3 groups: general anesthesia group, general anesthesia combined with brachial plexus block, and general anesthesia combined with suprascapular nerve block group. The dosage of vasoactive drugs and anesthetics, parameters of perioperative bleeding, hemodynamic parameters, systemic oxygen metabolism, kidney functions, as well as procedure process and postoperative adverse reactions were recorded and compared between the groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

July 17, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2025

Completed
Last Updated

July 19, 2022

Status Verified

June 1, 2022

Enrollment Period

2.2 years

First QC Date

June 20, 2022

Last Update Submit

July 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The dosage of total vasopressor-inotrope dose between groups

    The dosage of total vasopressor-inotrope dose (Calculate by formula) between the groups

    1 day

Secondary Outcomes (3)

  • The dosage of anesthetics between groups

    1 day

  • Blood pressure between the groups

    1 day

  • The incidence of postoperative complications

    3 day

Study Arms (3)

General anesthesia group

EXPERIMENTAL

Patients were maintained with propofol/remifentanil in general anesthesia

Procedure: General anesthesia

General anesthesia combined with brachial plexus block group

EXPERIMENTAL

An additional ultrasound-guided brachial plexus block were performed

Procedure: Brachial plexus blockProcedure: General anesthesia

general anesthesia combined with suprascapular nerve block group

EXPERIMENTAL

An additional ultrasound-guided suprascapular nerve block were performed

Procedure: General anesthesiaProcedure: Suprascapular nerve block

Interventions

An additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group

Also known as: General anesthesia combined with brachial plexus block group
General anesthesia combined with brachial plexus block group

General anesthesia were performed according to clinical routine: induction drugs: propofol, sufentanil, rocuronium, maintenance drugs: propofol, sevoflurane and remifentanil, Laryngeal mask ventilation.

General anesthesia combined with brachial plexus block groupGeneral anesthesia groupgeneral anesthesia combined with suprascapular nerve block group

An additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group

Also known as: General anesthesia combined with suprascapular nerve block group
general anesthesia combined with suprascapular nerve block group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) planned elective arthroscopic shoulder surgery, need controlled hypotension under general anesthesia; (2) aged 60-75 years; (3) ASA grade II or III; and (4) estimated operative time \< 120 min.

You may not qualify if:

  • (1) preoperative blood pressure systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg or pulse pressure ≥ 60 mmHg; (2) comorbidities of severe cardiovascular disease, including cardiac function grade III or IV, severe aortic stenosis, aortic valve insufficiency, severe coronary heart disease, bradycardia, and atrioventricular block above degree I; (3) history of cerebral infarction, Alzheimer's disease, or cerebrovascular incident; (4) liver and/or kidney dysfunction; (5) severe anemia, shock, hypovolemia, or respiratory dysfunction; (6) previous history of phlebitis or thrombosis, closed-angle glaucoma; and (7) BMI \> 25 or \< 18. Patients with intraoperative blood loss \> 1500 mL or operation time \> 4 h would be further excluded from the analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Conditions

Shoulder Injuries

Interventions

Brachial Plexus BlockAnesthesia, General

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Gang Ma, doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

July 11, 2022

Study Start

July 17, 2022

Primary Completion

September 29, 2024

Study Completion

November 29, 2025

Last Updated

July 19, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations