Analgesic Effect of Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries.

NCT ID: NCT06999460

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-09
• Study Completion Date: 2026-01-30

Brief Summary

The aim of the study to evaluate the efficacy of the infraspinatus-teres minor (ITM) block in improving pre-emptive analgesia, reducing opioid consumption, and enhancing the overall analgesic effect in patients undergoing shoulder surgeries.

Detailed Description

To compare between infraspinatus-teres minor versus control group (GA):

1. To measure analgesic parameters including: the total amount of rescue analgesic consumption (morphine) in the first 24 hours post-operatively in each group, duration of analgesia, and total amount of intraoperative fentanyl consumption and

2. To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive or active movement of shoulder joint (dynamic).

3. To assess discharge time from post anesthesia care unit (PACU).

4. To assess side effects of systemic opioids (constipation, itching, dizziness, nausea and vomiting) and complications of infraspinatus-tere minor block.

5. Patients' satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Conditions

Preemptive Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

*Group Infraspinatus teres minor block (ITM group)

Patients in this group will receive a unilateral ultrasound-guided Infraspinatus-teres minor (ITM) block with injection of local anesthetics (20 mL of bupivacaine 0.25% (50 mg), 50 mcg dexmedetomidine (0.5 ml) and 8 mg dexamethasone (2 ml)) before induction of general anesthesia

Group Type: ACTIVE_COMPARATOR

Infraspinatus teres minor block group

Intervention Type: PROCEDURE

Patients in this group will receive a unilateral ultrasound-guided Infraspinatus-teres minor (ITM) block with injection of local anesthetics (20 mL of bupivacaine 0.25% (50 mg), 50 mcg dexmedetomidine (0.5 ml) and 8 mg dexamethasone (2 ml)) before induction of general anesthesia

Control group (group C)

Patients in this group will receive general anesthesia.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: PROCEDURE

Patients in this group will receive general anesthesia

Interventions

Infraspinatus teres minor block group

Patients in this group will receive a unilateral ultrasound-guided Infraspinatus-teres minor (ITM) block with injection of local anesthetics (20 mL of bupivacaine 0.25% (50 mg), 50 mcg dexmedetomidine (0.5 ml) and 8 mg dexamethasone (2 ml)) before induction of general anesthesia

Intervention Type: PROCEDURE

Control group

Patients in this group will receive general anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • Patients' acceptance.

• Age: Adults aged 21-65 years old.
• BMI: 25-30 kg/m2
• Sex: both sexes (males or females).
• Patients undergoing unilateral shoulder surgey under general anesthesia.
• ASA (American Society of Anesthesiologists) physical status classification I to II.
• Duration of the surgery < 3hours.

Exclusion Criteria

• • Patients with contraindications to regional anesthesia (e.g. local or systemic infections, or severe neurological or muscular or bleeding disorders or patient on anticoagulant).

• Allergy to study medications: bupivacaine or dexamethasone, or dexmedetomidine
• Patients with severe cardiovascular, respiratory, renal, or hepatic diseases, uncontrolled diabetes , or those undergoing chronic opioid therapy.
• Psychiatric disorders that hinder informed consent or study participation.
• history of neurological diseases or conditions that would affect the efficacy of nerve blocks (e.g., neuropathy, spinal cord injury, or history of severe muscle weakness).
• Patients with nerve injury or disease around the shoulder joint, including thoracic outlet syndrome, Multiple sclerosis, cervical disc disease with ipsilateral radiculopathy, or patients with abnormal sensory or motor function of the upper limb.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dina Abdelhameed Elsadek Salem

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculity of medicine, Zagazig university, Zagazig

Zagazig, Egypt, Egypt

Site Status: RECRUITING

Faculty of human medicine, Zagazig university, Zagazig

Zagazig, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina Elsadek Salem, MD

Role: CONTACT

dinamaghraby@yahoo.com

01099333513 ext. 002

Other Identifiers

1299

Identifier Type: -

Identifier Source: org_study_id