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CompletedNCT06240884Updated Jul 3, 2024

Postoperative Analgesic Effect of Infraspinatus-teres Minor Inter-fascial Block in Patients Undergoing Shoulder Surgery

An interventional study of Infraspinatus-teres minor interfascial block and interscalene block in Shoulder Pain, sponsored by Affiliated Hospital of Jiaxing University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Affiliated Hospital of Jiaxing University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Shoulder Pain

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Keywords

  • Infraspinatus-teres minor (ITM) interfascial block
  • shoulder arthroscopy
03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 74 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Affiliated Hospital of Jiaxing University is the lead sponsor of 16 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Shoulder joint surgery in Jiaxing First Hospital from November 2023 to February 2024;
  2. Age 18-80 years old;
  3. ASA Grade I-III;
  4. The duration of surgery is expected to be 1-3h

Exclusion criteria

Exclusion Criteria:

  1. accompanied by nerve injury or disease around the shoulder joint, including thoracic outlet syndrome, Multiple sclerosis, cervical disc disease with ipsilateral radiculopathy, etc.
  2. accompanied by abnormal sensory or motor function of the upper limb;
  3. Active infection at the puncture site, or coagulation dysfunction (hemophilia, von willeophilia, or International normalized ratio [INR]>2);
  4. Patients with severe respiratory diseases and a serious history of cardiovascular and cerebrovascular diseases;
  5. ipsilateral shoulder joint surgery history;
  6. Patients with nerve block failure;
  7. Allergic to local anesthetics;
  8. Long-term use of opioids (duration ≥3 months or duration ≥1 month and daily dose ≥5mg morphine equivalent);
  9. Operation time \<1h or >3h
  10. Patients and their families refused surgical anesthesia and were unable to complete the questionnaire.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Infraspinatus-teres minor interfascial block

    Patients will receive Infraspinatus-teres Minor Interfascial Block with 20 ml of 0.375% ropivacaine prior to induction of general anesthesia.

    Procedure: Infraspinatus-teres minor interfascial block

  • Active comparator
    interscalene block

    The patient underwent an ultrasound-guided brachial plexus nerve block in the interosseous sulcus using 20 ml of 0.375% ropivacaine.

    Procedure: interscalene block

Interventions

  • ProcedureInfraspinatus-teres minor interfascial block

    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.

  • Procedureinterscalene block

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 0-24 hours after surgery

Secondary outcomes

  1. Complications

    number of participants developed complications

    Time frame: during 48 hours after operation

  2. Asses The postoperative opioid consumption

    the postoperative opioid consumption during the procedure

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Affiliated Hospital of Jiaxing University
    Jiaxing, Zhejiang 314000, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No — research direction

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06240884
Lead sponsor
Affiliated Hospital of Jiaxing University
Responsible party
Qing-he Zhou (professor, Affiliated Hospital of Jiaxing University) — Principal investigator
First posted
Feb 5, 2024
Start date
Dec 8, 2023
Primary completion
Apr 5, 2024
Completion
Apr 12, 2024
Last update
Jul 3, 2024

Study contacts

QINGhe ZHOU
principal investigator · deputy chair of board

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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