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

Z

Zagazig University

Status

Enrolling

Conditions

Preemptive Analgesia

Treatments

Procedure: Infraspinatus teres minor block group
Procedure: Control group

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 estimated patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

*Group Infraspinatus teres minor block (ITM group)
Active Comparator group
Description:
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
Treatment:
Procedure: Infraspinatus teres minor block group
Control group (group C)
Active Comparator group
Description:
Patients in this group will receive general anesthesia.
Treatment:
Procedure: Control group

Trial contacts and locations

2

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Central trial contact

Dina Elsadek Salem, MD

Data sourced from clinicaltrials.gov

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