Clinical trial NCT06999460: Analgesic Effect of Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries.
Official title: A Novel Approach to Shoulder Analgesia: Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preemptive Analgesia
Keywords: infraspinatus teres minor block
preemptive analgesia
shoulder surgery
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To study the efficacy of the infraspinatus-teres minor (ITM) block as pre-emptive analgesia in pain management in patients undergoing shoulder surgeries.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: total amount of rescue analgesic consumption
timeFrame: for 24 hours
measure: total amount of intraoperative supplementary fentanyl consumption.
timeFrame: up to 3 hours
Secondary outcomes:
measure: Numerical Rate Scale (NRS) at rest (static) and during passive or active movement of shoulder (dynamic).
timeFrame: 30 minutes after arrival in the post-anesthesia care unit (PACU), 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.
measure: Time to the first request of rescue analgesia postoperatively
timeFrame: 24 hours postoperative
measure: Discharge time from post anesthesia care unit (PACU)
timeFrame: 24 hours
measure: To assess side effects of systemic opioids
timeFrame: for 24 hours
measure: the incidence of block -related side effects or complications
timeFrame: for 24 hours
measure: patient's satisfaction
timeFrame: for 24 hours
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculity of medicine, Zagazig university, Zagazig
city: Zagazig
country: Egypt
facility: Faculty of human medicine, Zagazig university, Zagazig
Study officials:
References: