Comparison Between Dexametidomedine\Bupivacaine and Plain Bupivacaine in Superior Trunk Block for Arthroscopic Shoulder Surgeries

NCT ID: NCT07046325

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-05-01

Brief Summary

Comparison between dexametidomedine\bupivacaine and plain bupivacaine in superior trunk block for arthroscopic shoulder surgeries

Detailed Description

This study will be conducted to investigate the efficacy of adding dexmedetomidine in STB for postoperative analgesia in patients undergoing arthroscopic shoulder surgery.

• Inclusion Criteria:

1. age ;20-50 years old of both genders

2. American Society of Anesthesiologists physical status I and II

3. BMI less than 30

4. Arthroscopic shoulder surgeries.

• Exclusion Criteria:

1. Patients with ASA more than II

2. Patients with a sepsis, malignancy anywhere

3. Patient with bleeding tendencies or on anticoagulation therapy

4. Patients with pre-existing neurologic deficit or neuropathy affecting brachial plexus

5. Allergy to study drugs.

Study groups:

The patients will be randomized into 2 groups:

1. Group DB: are administered Ultrasound guided STB with bupivacaine and dexametidomedine.

2. Group B: are administered Ultrasound guided STB with bupivacaine.

Primary outcome:

Duration of analgesia of Superior trunck block.

Secondary outcome:

1. Cumulative dose of postoperative consumption of the rescue analgesia during 24h after STB

2. Durations of motor blockade (DOM)

3. Residual block related neurological symptoms

4. Hemodynamic variables

5. Dyspnea and sedation scale.

Conditions

Post Operative Pain, Acute; Arthroscopic Shoulder Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

group B

group administered Ultrasound guided STB with bupivacaine

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

2\. Group B: are administered Ultrasound guided STB with bupivacaine.

group DB

group administered Ultrasound guided STB with bupivacaine and dexametidomedine.

Group Type: ACTIVE_COMPARATOR

dexametedomidine

Intervention Type: DRUG

1\. Group DB: are administered Ultrasound guided STB with bupivacaine and dexametidomedine.

Bupivacain

Intervention Type: DRUG

2\. Group B: are administered Ultrasound guided STB with bupivacaine.

Interventions

dexametedomidine

1\. Group DB: are administered Ultrasound guided STB with bupivacaine and dexametidomedine.

Intervention Type: DRUG

Bupivacain

2\. Group B: are administered Ultrasound guided STB with bupivacaine.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ;20-50 years old
• Both genders
• American Society of Anesthesiologists physical status I and II
• BMI less than 30
• Arthroscopic shoulder surgeries.

Exclusion Criteria

• Patients with ASA more than II
• Patients with a sepsis, malignancy anywhere
• Patient with bleeding tendencies or on anticoagulation therapy
• Patients with pre-existing neurologic deficit or neuropathy affecting brachial plexus
• Allergy to study drugs.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

fagr fathy abdo, Medical Doctorate

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

FMASU R112/2025

Identifier Type: -

Identifier Source: org_study_id