Analgesic Effect of Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Infraspinatus teres minor block group, Control group.
- Who it may be relevant to
- Registry conditions: Preemptive Analgesia. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Procedure Infraspinatus teres minor block group
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 Control group
Patients in this group will receive general anesthesia
Primary outcome measures
- total amount of rescue analgesic consumption [Time frame: for 24 hours]
- total amount of intraoperative supplementary fentanyl consumption. [Time frame: up to 3 hours]
Secondary outcome measures (6)
- 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.]
- Time to the first request of rescue analgesia postoperatively [Time frame: 24 hours postoperative]
- Discharge time from post anesthesia care unit (PACU) [Time frame: 24 hours]
- To assess side effects of systemic opioids [Time frame: for 24 hours]
- the incidence of block -related side effects or complications [Time frame: for 24 hours]
- patient's satisfaction [Time frame: for 24 hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Faculity of medicine, Zagazig university, Zagazig — Zagazig
- Faculty of human medicine, Zagazig university, Zagazig — Zagazig
Identifiers
NCT: NCT06999460 · 1299