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Completed

NCT Number: NCT05822414

ESP vs STB for Pain and Diaphragm Function for Shoulder Surgery

To compare the efficacy of pain control, shoulder function recovery, and degree of diaphragm palsy between erector spinae plane block at T2 level and superior trunk block after arthroscopic shoulder surgery

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

Arthroscopic shoulder surgery can cause a substantial degree of postoperative pain that interferes with postoperative recovery. Adequate perioperative pain control can not only decrease duration of hospital length of stay and prevent unnecessary re-admission, but also facilitate postoperative rehabilitation and improve overall quality of life.

According to the 2019 PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations, published on Anesthesia, postoperative pain can be controlled by systemic analgesics such as paracetamol and NSAIDS, regional analgesia, and opioids as rescue analgesia.

The current nerve block of choice is the interscalene brachial plexus block. It can provide adequate pain control, but is associated with several drawbacks including neurological injuries from direct nerve contact and pneumothorax, with the potential for phrenic nerve blockade and hemidiaphragmatic paresis raising the most concern. The superior trunk block, which is performed at where the C5 and C6 roots converge to form the superior trunk, was therefore developed, as it is located further away from the phrenic nerve. However, there are still considerable risks of phrenic nerve blockade, as well as nerve injury from direct contact and upper limb motor blockade.

The erector spinae plane block, first described by Forero et al. in 2016, involves the injection of local anaesthetic deep to the erector spinae muscles and has been widely studied for analgesia in thoracic surgery. It is a paraspinal fascial plane block and is assumed to share the same mechanism at different vertebral levels, including cervical and lumbar, to provide analgesia for a variety of different surgeries, including spine and breast surgeries. In recent years, erector spinae plane block performed at T2 level has also been employed for chronic shoulder pain and arthroscopic shoulder surgery perioperative pain management. Significant better perioperative pain control was achieved when compared with sham block using normal saline by Cftci et al. in 2021 and non inferior pain control was achieved when compared with peri-articular injection of local anesthetics by Shanthanna et al in 2022.

To date, there is no head to head trial comparing the effect of the established block of choice, interscalene brachial plexus block or superior trunk block, to the more novel T2 erector spinae plane block. We therefore designed this study to compare the use of superior trunk block and T2 erector spinae plane block in arthroscopic shoulder surgery with respect to their respective analgesic efficacy and undesired side effect of hemidiaphragm palsy. Primary outcomes of the study are postoperative pain score evaluated by the 100mm-visual analogue scale and morphine consumption, and diaphragm excursion assessed with ultrasonography, while the secondary outcomes include patient reported outcomes assessed by Quality of Recovery-15 (QOR-15) and Shoulder Pain and Disability Index (SPADI)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients receiving arthroscopic shoulder surgery

Exclusion criteria

  • patients with age <18 and >85
  • pregnancy
  • patients with severe organ failure: respiratory failure (FEV1 (Forced expiratory volume) /FVC (forced vital capacity)<70% and FEV1< 50%), heart failure (NYHA class III, IV), renal failure (eGFR<60ml/min/1.73m^2)
  • patients diagnosed with chronic obstructive lung disease
  • patients with arrhythmia
  • patients with ongoing infection
  • patients with chronic opioid use or substance abuse history
  • patients with coagulopathy

Treatment and study plan

Erector Spinae Plane Block

Procedure

Erector spinae plane block will be injected at the second thoracic vertebral level for patient undergoing rotator cuff repair surgery

Primary outcomes

  1. Assessment of postoperative pain severity

    Time frame: one hour and 24-hour after surgery

    Postoperative pain severity evaluated by 100mm-visual analogue scale (0-100; 0 means no pain at all and 100 means the worst pain intensity)

  2. Assessment of diaphragm movement after block performance

    Time frame: before surgery and one hour after surgery

    Diaphragm movement evaluated by ultrasonography

Secondary outcomes

  1. Assessment of postoperative quality of recovery

    Time frame: before surgery and 24 hours after surgery

    Postoperative quality of recovery evaluated by quality of recovery 15 (QoR-15)

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Erector Spinae Plane Block vs. Superior Trunk Block for Postoperative Pain Control After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2023
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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