Shoulder PainNCT06240884
Postoperative Analgesic Effect of Infraspinatus-teres Minor Inter-fascial Block in Patients Undergoing Shoulder Surgery
A study testing Infraspinatus-teres minor interfascial block and interscalene block in people with Shoulder Pain, run by Affiliated Hospital of Jiaxing University at 1 site in China.
Trial summary
It is proposed to investigate the effectiveness of ultrasound-guided intertrochanteric block of the infraspinatus minor round myofascial block not inferior to the interosseous groove brachial plexus nerve block in postoperative analgesia and overall quality of recovery in shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Infraspinatus-teres minor interfascial block and interscalene block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2023to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Shoulder joint surgery in Jiaxing First Hospital from November 2023 to February 2024;
- Age 18-80 years old;
- ASA Grade I-III;
- The duration of surgery is expected to be 1-3h
Who cannot join
- accompanied by nerve injury or disease around the shoulder joint, including thoracic outlet syndrome, Multiple sclerosis, cervical disc disease with ipsilateral radiculopathy, etc.
- accompanied by abnormal sensory or motor function of the upper limb;
- Active infection at the puncture site, or coagulation dysfunction (hemophilia, von willeophilia, or International normalized ratio [INR]>2);
- Patients with severe respiratory diseases and a serious history of cardiovascular and cerebrovascular diseases;
- ipsilateral shoulder joint surgery history;
- Patients with nerve block failure;
Show all 10Show fewer
- Allergic to local anesthetics;
- Long-term use of opioids (duration ≥3 months or duration ≥1 month and daily dose ≥5mg morphine equivalent);
- Operation time <1h or >3h
- Patients and their families refused surgical anesthesia and were unable to complete the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound-guided Infraspinatus Tubercle Muscle (ITM) Interfascial Block and Interosseous Groove Nerve Block (ISB) for Postoperative Pain Management After Shoulder Arthroscopy: a Randomised, Non-inferiority Study
It is proposed to investigate the effectiveness of ultrasound-guided intertrochanteric block of the infraspinatus minor round myofascial block not inferior to the interosseous groove brachial plexus nerve block in postoperative analgesia and overall quality of recovery in shoulder surgery.
Read the detailed description
Intersulcus brachial plexus nerve block is considered to be the best method for pain nerve block after shoulder joint surgery. It can not only effectively reduce the postoperative pain and discomfort of patients, but also reduce the intraoperative demand for opioids. However, the use of intermuscular brachial plexus block should be prohibited when the patient has a clotting disorder or is taking anticoagulant drugs, has a local infection or a systemic infection. There may also be anesthesia risks such as nerve damage, vascular damage, respiratory depression, and diaphragmatic paralysis with dyspnea.
Infraspinatus-teres minor (ITM), first proposed by Shin Hyung Kim, is a single-site injection in the interfascial plane between Infraspinatus and teres minor. Once the IS and Tm on the humeral head area are identified, by moving the probe mediocaudally, the interfascial structure of the IS and Tm can be traced along the glenohumeral joint, scapular neck area. On autopsy, local anesthetics were found to have spread to the suprascapular and axillary nerves. This result suggests that interfascia block injection of local anesthetics between the infraspinatus and teres minor muscles may help relieve pain in the upper shoulder, back, and external sensory areas. At present, there are few clinical reports on the use of infraspinatus-teres minor interfascial block for postoperative analgesia of shoulder joint, and the postoperative analgesia effect is only reported in individual cases, without comparison with other nerve blocks There are few studies on the clinical application of ITM block, but ISB has become the best method for postoperative analgesia of shoulder joint surgery. the investigators designed a prospective, randomized controlled, non-inferior study to investigate the efficacy of ultrasound-guided subaspina-teres minor interfascial block in analgesia and overall quality of recovery after shoulder joint surgery.
The primary outcome indicator was the area under the NRS curve at rest in the 0-24h postoperative period
- Conditions
- Shoulder Pain
- Being tested
- Infraspinatus-teres minor interfascial block, interscalene block
- Keywords
- Infraspinatus-teres minor (ITM) interfascial block, shoulder arthroscopy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraspinatus-teres minor interfascial blockProcedure or surgery
After identifying the infraspinatus and teres minor muscles on the posterior surface of the scapular neck. Under real-time ultrasound guidance, the needle is advanced into the interfascial plane between the infraspinatus and teres minor muscles using an in-plane technique, and after confirming the fascial opening with 3 to 5 mL of 0.375% ropivacaine (20 mL total dose), the remaining 0.375% ropivacaine is injected. After extubation and the patients were awake, anesthesiologists who were unaware of the study subgroups began to assess the analgesic effect of the patients' block at rest using the numeric pain rating scale (NRS) at 0.5h, 3h, 6h, 12h, 18h, 24h, and 48h postoperatively.
interscalene blockProcedure or surgery
The tip of the needle was placed between the C5 and C6 nerve roots, and after a bloodless retraction with 0.5 to 1 ml of 0.375% ropivacaine to confirm nerve displacement, the remaining 0.375% ropivacaine was injected (total dose of 20 ml). Subsequently, the catheter was inserted over the needle and the needle was withdrawn.After extubation and the patients were awake, anesthesiologists who were unaware of the study subgroups began to assess the analgesic effect of the patients' block at rest using the numeric pain rating scale (NRS) at 0.5h, 3h, 6h, 12h, 18h, 24h, and 48h postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Infraspinatus-teres minor interfascial block | Experimental | Patients will receive Infraspinatus-teres Minor Interfascial Block with 20 ml of 0.375% ropivacaine prior to induction of general anesthesia. Receives: Procedure: Infraspinatus-teres minor interfascial block |
| interscalene block | Active comparator | The patient underwent an ultrasound-guided brachial plexus nerve block in the interosseous sulcus using 20 ml of 0.375% ropivacaine. Receives: Procedure: interscalene block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the NRS curve at rest during 0-24h postoperatively
Anesthesiologists who were not aware of the study subgroups began to assess the analgesic effect of the patients' block at rest using the numeric pain rating scale (NRS) at 0.5h, 3h, 6h, 12h, 18h, and 24h postoperatively.Score range from 0 (no pain) to 10 (worst pain possible).
Measured: 0-24 hours after surgery
Secondary outcomes (2)
Complications
number of participants developed complications
Measured: during 48 hours after operation
Asses The postoperative opioid consumption
the postoperative opioid consumption during the procedure
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start8 Dec 2023
- Primary completion5 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
- Investigators
- QINGhe ZHOU, Principal investigator, deputy chair of board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240884
- Sponsor's protocol ID
- 2023-KY-676
- Status last verified
- Jun 2024
- First submitted
- 2 Jan 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: research direction
Publications
Kim SH, Yeo IS, Jang J, Jung HE, Chun YM, Yang HM. Infraspinatus-teres minor (ITM) interfascial block: a novel approach for combined suprascapular and axillary nerve block. Reg Anesth Pain Med. 2024 Jan 11;49(1):67-72. doi: 10.1136/rapm-2023-104738.
PubMed 37491150
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Infraspinatus Tubercle Muscle (ITM) Interfascial Block and Interosseous Groove Nerve Block (ISB) for Postoperative Pain Management After Shoulder Arthroscopy: a Randomised, Non-inferiority Study
- ClinicalTrials.gov ID
- NCT06240884
- Acronym / sponsor ID
- 2023-KY-676
- Conditions
- Shoulder Pain
- Keywords
- Infraspinatus-teres minor (ITM) interfascial block, shoulder arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 5 Feb 2024 (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.
It is proposed to investigate the effectiveness of ultrasound-guided intertrochanteric block of the infraspinatus minor round myofascial block not inferior to the interosseous groove brachial plexus nerve block in postoperative analgesia and overall quality of recovery in shoulder surgery.
Detailed description
Intersulcus brachial plexus nerve block is considered to be the best method for pain nerve block after shoulder joint surgery. It can not only effectively reduce the postoperative pain and discomfort of patients, but also reduce the intraoperative demand for opioids. However, the use of intermuscular brachial plexus block should be prohibited when the patient has a clotting disorder or is taking anticoagulant drugs, has a local infection or a systemic infection. There may also be anesthesia risks such as nerve damage, vascular damage, respiratory depression, and diaphragmatic paralysis with dyspnea.
Infraspinatus-teres minor (ITM), first proposed by Shin Hyung Kim, is a single-site injection in the interfascial plane between Infraspinatus and teres minor. Once the IS and Tm on the humeral head area are identified, by moving the probe mediocaudally, the interfascial structure of the IS and Tm can be traced along the glenohumeral joint, scapular neck area. On autopsy, local anesthetics were found to have spread to the suprascapular and axillary nerves. This result suggests that interfascia block injection of local anesthetics between the infraspinatus and teres minor muscles may help relieve pain in the upper shoulder, back, and external sensory areas. At present, there are few clinical reports on the use of infraspinatus-teres minor interfascial block for postoperative analgesia of shoulder joint, and the postoperative analgesia effect is only reported in individual cases, without comparison with other nerve blocks There are few studies on the clinical application of ITM block, but ISB has become the best method for postoperative analgesia of shoulder joint surgery. the investigators designed a prospective, randomized controlled, non-inferior study to investigate the efficacy of ultrasound-guided subaspina-teres minor interfascial block in analgesia and overall quality of recovery after shoulder joint surgery.
The primary outcome indicator was the area under the NRS curve at rest in the 0-24h postoperative period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infraspinatus-teres minor interfascial block | Experimental | Procedure: Infraspinatus-teres minor interfascial blockPatients will receive Infraspinatus-teres Minor Interfascial Block with 20 ml of 0.375% ropivacaine prior to induction of general anesthesia. |
| interscalene block | Active comparator | Procedure: interscalene blockThe patient underwent an ultrasound-guided brachial plexus nerve block in the interosseous sulcus using 20 ml of 0.375% ropivacaine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Shoulder joint surgery in Jiaxing First Hospital from November 2023 to February 2024;
- Age 18-80 years old;
- ASA Grade I-III;
- The duration of surgery is expected to be 1-3h
Key exclusion criteria (10 listed)
- accompanied by nerve injury or disease around the shoulder joint, including thoracic outlet syndrome, Multiple sclerosis, cervical disc disease with ipsilateral radiculopathy, etc.
- accompanied by abnormal sensory or motor function of the upper limb;
- Active infection at the puncture site, or coagulation dysfunction (hemophilia, von willeophilia, or International normalized ratio [INR]>2);
- Patients with severe respiratory diseases and a serious history of cardiovascular and cerebrovascular diseases;
- ipsilateral shoulder joint surgery history;
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 interfascial blockAfter identifying the infraspinatus and teres minor muscles on the posterior surface of the scapular neck. Under real-time ultrasound guidance, the needle is advanced into the interfascial plane between the infraspinatus and teres minor muscles using an in-plane technique, and after confirming the fascial opening with 3 to 5 mL of 0.375% ropivacaine (20 mL total dose), the remaining 0.375% ropivacaine is injected. After extubation and the patients were awake, anesthesiologists who were unaware of the study subgroups began to assess the analgesic effect of the patients' block at rest using the numeric pain rating scale (NRS) at 0.5h, 3h, 6h, 12h, 18h, 24h, and 48h postoperatively. | Procedure or surgery | Infraspinatus-teres minor interfascial block |
| interscalene blockThe tip of the needle was placed between the C5 and C6 nerve roots, and after a bloodless retraction with 0.5 to 1 ml of 0.375% ropivacaine to confirm nerve displacement, the remaining 0.375% ropivacaine was injected (total dose of 20 ml). Subsequently, the catheter was inserted over the needle and the needle was withdrawn.After extubation and the patients were awake, anesthesiologists who were unaware of the study subgroups began to assess the analgesic effect of the patients' block at rest using the numeric pain rating scale (NRS) at 0.5h, 3h, 6h, 12h, 18h, 24h, and 48h postoperatively. | Procedure or surgery | interscalene block |
Primary outcome
Area under the NRS curve at rest during 0-24h postoperatively
Time frame: 0-24 hours after surgery
Anesthesiologists who were not aware of the study subgroups began to assess the analgesic effect of the patients' block at rest using the numeric pain rating scale (NRS) at 0.5h, 3h, 6h, 12h, 18h, and 24h postoperatively.Score range from 0 (no pain) to 10 (worst pain possible).
2 secondary outcomes
Complications
Time frame: during 48 hours after operation
Asses The postoperative opioid consumption
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Results publication: PubMed 37491150Kim SH, Yeo IS, Jang J, Jung HE, Chun YM, Yang HM. Infraspinatus-teres minor (ITM) interfascial block: a novel approach for combined suprascapular and axillary nerve block. Reg Anesth Pain Med. 2024 Jan 11;49(1):67-72. doi: 10.1136/rapm-2023-104738.
- Individual participant dataSharing planned: No. research direction
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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. This study is not recruiting at the moment.
QINGhe ZHOU principal investigator
deputy chair of board
1 site 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 interfascial block and interscalene block in people with Shoulder Pain, run by Affiliated Hospital of Jiaxing University at 1 site in China.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the NRS curve at rest during 0-24h postoperatively (time frame: 0-24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06240884, which also lists 1 linked publication.
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 3 Jul 2024.