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

Not Applicable

Recruiting

• Conditions: Preemptive Analgesia

• Registration Number: NCT06999460
• Lead Sponsor: Zagazig University

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).

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-22
• Study First Posted: 2025-05-31
• Study Start: 2025-06-09
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
total amount of rescue analgesic consumption	for 24 hours	To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group.
total amount of intraoperative supplementary fentanyl consumption.	up to 3 hours	To measure total amount of intraoperative supplementary fentanyl consumption.

Secondary Outcome Measures

Name	Time	Method
the incidence of block -related side effects or complications	for 24 hours	To assess the incidence of block -related side effects or complications (hematoma, infection or LA toxicity).
To assess side effects of systemic opioids	for 24 hours	To assess side effects of systemic opioids (constipation, itching, dizziness, nausea \& vomiting
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.	To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive or active movement of shoulder (dynamic). NRS scale will be explained to all patients as follows: 0= no pain and 10= worst pain.
Time to the first request of rescue analgesia postoperatively	24 hours postoperative	To assess the time to the first request of rescue analgesia (morphine) postoperatively
Discharge time from post anesthesia care unit (PACU)	24 hours	the time from admission to the post-anesthesia care unit (PACU) till discharge from the PACU when the Aldrete score is ≥9).
patient's satisfaction	for 24 hours	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)

Trial Locations

Locations (2)

Faculity of medicine, Zagazig university, Zagazig; 🇪🇬 Zagazig, Egypt

Faculty of human medicine, Zagazig university, Zagazig; 🇪🇬 Zagazig, Egypt