Preemptive AnalgesiaNCT06999460
Analgesic Effect of Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries.
A study testing Infraspinatus teres minor block group in people with Preemptive Analgesia, run by Zagazig University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Preemptive Analgesia
- What is being tested?
- Infraspinatus teres minor block group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 9 Jun 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Faculity of medicine, Zagazig university, Zagazig
Zagazig, Egypt
- Recruiting
Faculty of human medicine, Zagazig university, Zagazig
Zagazig
About this study
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
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.
Read the detailed description
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).
- Conditions
- Preemptive Analgesia
- Being tested
- Infraspinatus teres minor block group, Control group
- Keywords
- infraspinatus teres minor block, preemptive analgesia, shoulder surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraspinatus teres minor block groupProcedure or surgery
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 groupProcedure or surgery
Patients in this group will receive general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| *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 Receives: Procedure: Infraspinatus teres minor block group |
| Control group (group C) | Active comparator | Patients in this group will receive general anesthesia. Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for 24 hours
total amount of intraoperative supplementary fentanyl consumption.
To measure total amount of intraoperative supplementary fentanyl consumption.
Measured: up to 3 hours
Secondary outcomes (6)
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.
Measured: 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
To assess the time to the first request of rescue analgesia (morphine) postoperatively
Measured: 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).
Measured: 24 hours
To assess side effects of systemic opioids
To assess side effects of systemic opioids (constipation, itching, dizziness, nausea \& vomiting
Measured: 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).
Measured: 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)
Measured: for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start9 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preemptive AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999460
- Sponsor's protocol ID
- 1299
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06999460
- Acronym / sponsor ID
- 1299
- Conditions
- Preemptive Analgesia
- Keywords
- infraspinatus teres minor block, preemptive analgesia, shoulder surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| *Group Infraspinatus teres minor block (ITM group) | Active comparator | Procedure: Infraspinatus teres minor block groupPatients 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 | Procedure: Control groupPatients in this group will receive general anesthesia. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Patients' acceptance.
Key exclusion criteria (6 listed)
- • Patients with contraindications to regional anesthesia (e.g. local or systemic infections, or severe neurological or muscular or bleeding disorders or patient on anticoagulant).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infraspinatus teres minor block groupPatients 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 or surgery | *Group Infraspinatus teres minor block (ITM group) |
| Control groupPatients in this group will receive general anesthesia | Procedure or surgery | Control group (group C) |
Primary outcome
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.
total amount of intraoperative supplementary fentanyl consumption.
Time frame: up to 3 hours
To measure total amount of intraoperative supplementary fentanyl consumption.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraspinatus teres minor block group in people with Preemptive Analgesia, run by Zagazig University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Elsadek Salem, MD (01099333513 ext. 002, dinamaghraby@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total amount of rescue analgesic consumption (time frame: for 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.