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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.
To compare between infraspinatus-teres minor versus control group (GA):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| *Group Infraspinatus teres minor block (ITM group) | Active Comparator | 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 (group C) | Active Comparator | Patients in this group will receive general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| total amount of rescue analgesic consumption | To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group. | for 24 hours |
| total amount of intraoperative supplementary fentanyl consumption. | To measure total amount of intraoperative supplementary fentanyl consumption. | up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rate Scale (NRS) at rest (static) and during passive or active movement of shoulder (dynamic). | 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. | 30 minutes after arrival in the post-anesthesia care unit (PACU), 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively. |
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Inclusion Criteria:
• Patients' acceptance.
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina Elsadek Salem, MD | Contact | 01099333513 | 002 | dinamaghraby@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculity of medicine, Zagazig university, Zagazig | Recruiting | Zagazig | Egypt | Egypt | ||
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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To study the efficacy of the infraspinatus-teres minor (ITM) block as pre-emptive analgesia in pain management in patients undergoing shoulder surgeries.
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Anesthetist not sharing in the study will assess outcomes
|
| Control group | Procedure | Patients in this group will receive general anesthesia |
|
| Time to the first request of rescue analgesia postoperatively | To assess the time to the first request of rescue analgesia (morphine) postoperatively | 24 hours postoperative |
| Discharge time from post anesthesia care unit (PACU) | the time from admission to the post-anesthesia care unit (PACU) till discharge from the PACU when the Aldrete score is ≥9). | 24 hours |
| To assess side effects of systemic opioids | To assess side effects of systemic opioids (constipation, itching, dizziness, nausea & vomiting | for 24 hours |
| the incidence of block -related side effects or complications | To assess the incidence of block -related side effects or complications (hematoma, infection or LA toxicity). | for 24 hours |
| patient's 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) | for 24 hours |
| Faculty of human medicine, Zagazig university, Zagazig |
| Recruiting |
| Zagazig |
| Egypt |
| D008722 | Methods |