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

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06240884
• Other study ID #: 2023-KY-676
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: Affiliated Hospital of Jiaxing University
• Contact: QINGhe ZHOU, professor
• Phone: 17334528826
• Email: 17334528826[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• Infraspinatus-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.
• interscalene 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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Jiaxing University	Jiaxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiaxing University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	0-24 hours after surgery
Secondary	Complications	number of participants developed complications	during 48 hours after operation
Secondary	Asses The postoperative opioid consumption	the postoperative opioid consumption during the procedure	24 hours postoperatively