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

NCT06999460 | Recruiting

• 1 other identifier: 1299
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Preemptive Analgesia

Keywords

infraspinatus teres minor block; preemptive analgesia; shoulder surgery

Outcome Measures

Primary Outcomes (2)

• total amount of rescue analgesic consumption

  To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group.

  for 24 hours

• total amount of intraoperative supplementary fentanyl consumption.

  To measure total amount of intraoperative supplementary fentanyl consumption.

  up to 3 hours

Secondary Outcomes (6)

• Numerical Rate Scale (NRS) at rest (static) and during passive or active movement of shoulder (dynamic).

  30 minutes after arrival in the post-anesthesia care unit (PACU), 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.

• Time to the first request of rescue analgesia postoperatively

  24 hours postoperative

• Discharge time from post anesthesia care unit (PACU)

  24 hours

• To assess side effects of systemic opioids

  for 24 hours

• the incidence of block -related side effects or complications

  for 24 hours

Study Arms (2)

*Group Infraspinatus teres minor block (ITM group)

ACTIVE COMPARATOR

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

Procedure: Infraspinatus teres minor block group

Control group (group C)

ACTIVE COMPARATOR

Patients in this group will receive general anesthesia.

Procedure: Control group

Interventions

Infraspinatus teres minor block group 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

*Group Infraspinatus teres minor block (ITM group)

Control group PROCEDURE

Patients in this group will receive general anesthesia

Control group (group C)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Faculity of medicine, Zagazig university, Zagazig

Zagazig, Egypt, Egypt

RECRUITING

Faculty of human medicine, Zagazig university, Zagazig

Zagazig, Egypt

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Dina Elsadek Salem, MD

CONTACT

01099333513; dinamaghraby@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Anesthetist not sharing in the study will assess outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: To study the efficacy of the infraspinatus-teres minor (ITM) block as pre-emptive analgesia in pain management in patients undergoing shoulder surgeries.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 31, 2025
• Study Start: June 9, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)