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

NCT06240884 | Completed

• 1 other identifier: 2023-KY-676
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Pain

Keywords

Infraspinatus-teres minor (ITM) interfascial block; shoulder arthroscopy

Outcome Measures

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).

  0-24 hours after surgery

Secondary Outcomes (2)

• Complications

  during 48 hours after operation

• Asses The postoperative opioid consumption

  24 hours postoperatively

Study Arms (2)

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.

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.

Procedure: interscalene block

Interventions

Infraspinatus-teres minor interfascial block PROCEDURE

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.

Infraspinatus-teres minor interfascial block

interscalene block PROCEDURE

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.

interscalene block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, 314000, China

Location

Related 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.

  PMID: 37491150 RESULT

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• QINGhe ZHOU

  deputy chair of board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 5, 2024
• Study Start: December 8, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 12, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)