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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06999460
Enrollment
60
Registered
2025-05-31
Start date
2025-06-09
Completion date
2026-01-30
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preemptive Analgesia

Keywords

infraspinatus teres minor block, preemptive analgesia, shoulder surgery

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).

Interventions

PROCEDUREInfraspinatus 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

PROCEDUREControl group

Patients in this group will receive general anesthesia

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Anesthetist not sharing in the study will assess outcomes

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.

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
total amount of rescue analgesic consumptionfor 24 hoursTo assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group.
total amount of intraoperative supplementary fentanyl consumption.up to 3 hoursTo measure total amount of intraoperative supplementary fentanyl consumption.

Secondary

MeasureTime frameDescription
Discharge time from post anesthesia care unit (PACU)24 hoursthe time from admission to the post-anesthesia care unit (PACU) till discharge from the PACU when the Aldrete score is ≥9).
To assess side effects of systemic opioidsfor 24 hoursTo assess side effects of systemic opioids (constipation, itching, dizziness, nausea & vomiting
Numerical Rate Scale (NRS) at rest (static) and during passive or active movement of shoulder (dynamic).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.
patient's satisfactionfor 24 hoursThe 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)
the incidence of block -related side effects or complicationsfor 24 hoursTo assess the incidence of block -related side effects or complications (hematoma, infection or LA toxicity).
Time to the first request of rescue analgesia postoperatively24 hours postoperativeTo assess the time to the first request of rescue analgesia (morphine) postoperatively

Countries

Egypt

Contacts

Primary ContactDina Elsadek Salem, MD
dinamaghraby@yahoo.com01099333513

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026