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NCT Number: NCT06999460

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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculity of medicine, Zagazig university, Zagazig, Zagazig, Egypt

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About this study

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

  • 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
  • To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive or active movement of shoulder joint (dynamic).
  • To assess discharge time from post anesthesia care unit (PACU).
  • To assess side effects of systemic opioids (constipation, itching, dizziness, nausea and vomiting) and complications of infraspinatus-tere minor block.
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Control Group

Procedure

Patients in this group will receive general anesthesia

Primary outcomes

  1. total amount of rescue analgesic consumption

    Time frame: for 24 hours

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

  2. total amount of intraoperative supplementary fentanyl consumption.

    Time frame: up to 3 hours

    To measure total amount of intraoperative supplementary fentanyl consumption.

Secondary outcomes

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

    Time frame: 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.

  2. Time to the first request of rescue analgesia postoperatively

    Time frame: 24 hours postoperative

    To assess the time to the first request of rescue analgesia (morphine) postoperatively

  3. Discharge time from post anesthesia care unit (PACU)

    Time frame: 24 hours

    the time from admission to the post-anesthesia care unit (PACU) till discharge from the PACU when the Aldrete score is ≥9).

  4. To assess side effects of systemic opioids

    Time frame: for 24 hours

    To assess side effects of systemic opioids (constipation, itching, dizziness, nausea & vomiting

  5. the incidence of block -related side effects or complications

    Time frame: for 24 hours

    To assess the incidence of block -related side effects or complications (hematoma, infection or LA toxicity).

  6. patient's satisfaction

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Elsadek Salem, MD

CONTACT

[email protected]

01099333513 ext. 002

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

A Novel Approach to Shoulder Analgesia: Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries: A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 31, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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