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Recruiting NCT07668648

Interscalene Brachial Plexus Block Versus Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery

No phase Interventional Postoperative Pain Shoulder Arthroscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interscalene Brachial Plexus Block, Serratus Posterior Superior Intercostal Plane Block, Bupivacaine.
Who it may be relevant to
Registry conditions: Postoperative Pain, Shoulder Arthroscopy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Interscalene Brachial Plexus Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery: A Prospective, Randomized, Double-Blind Controlled Trial

Overview

Arthroscopic shoulder surgery is associated with moderate to severe postoperative pain that may delay recovery and rehabilitation. Interscalene brachial plexus block (ISB) is widely used for postoperative analgesia in shoulder surgery; however, it may be associated with complications such as phrenic nerve paralysis. The serratus posterior superior intercostal plane (SPSIP) block is a recently described fascial plane block that may provide effective analgesia while avoiding some of the limitations of ISB. This prospective, randomized, double-blind controlled trial aims to compare the analgesic efficacy of ISB and SPSIP block in patients undergoing elective arthroscopic shoulder surgery under general anesthesia. The primary outcome is total postoperative opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, quality of recovery, time to first rescue analgesia, rescue analgesic requirements, intraoperative opioid consumption, sensory block distribution, motor block characteristics, and block-related complications.

Detailed description

Postoperative pain following arthroscopic shoulder surgery can adversely affect patient comfort, early mobilization, rehabilitation, and overall recovery. Although the interscalene brachial plexus block is considered the reference regional anesthesia technique for shoulder surgery, its use may be limited by adverse effects such as hemidiaphragmatic paresis, phrenic nerve involvement, and upper extremity motor weakness.

The serratus posterior superior intercostal plane block is a novel ultrasound-guided fascial plane block targeting the posterior thoracic region. Preliminary evidence suggests that it may provide analgesia extending to the shoulder area through spread to cervical and upper thoracic dermatomes. However, comparative clinical evidence between SPSIP block and ISB for arthroscopic shoulder surgery remains limited.

In this prospective, randomized, double-blind controlled trial, eligible adult patients scheduled for elective arthroscopic shoulder surgery under general anesthesia will be randomly assigned to receive either an ultrasound-guided ISB or SPSIP block. All patients will receive standardized general anesthesia and postoperative multimodal analgesia.

The primary endpoint will be total opioid consumption during the first 24 postoperative hours. Secondary endpoints will include postoperative Numeric Rating Scale (NRS) pain scores at predefined time points, quality of recovery assessed with the QoR-15 questionnaire, intraoperative opioid consumption, time to first rescue analgesic requirement, total rescue analgesic consumption, sensory block distribution, motor block assessment, and block-related adverse events.

The study aims to determine whether SPSIP block can provide postoperative analgesia comparable to ISB while potentially reducing complications associated with brachial plexus blockade.

Interventions

  • Procedure Interscalene Brachial Plexus Block
    Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.
  • Procedure Serratus Posterior Superior Intercostal Plane Block
    Ultrasound-guided serratus posterior superior intercostal plane block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.
  • Drug Bupivacaine
    Bupivacaine administered for ultrasound-guided regional anesthesia block.

Primary outcome measures

  • Total Opioid Consumption During the First 24 Postoperative Hours [Time frame: 24 hours after surgery]
Secondary outcome measures (6)
  • Postoperative Pain Scores [Time frame: 0, 2, 4, 8, 16, and 24 hours after surgery]
  • Quality of Recovery (QoR-15) [Time frame: 24 hours after surgery]
  • Intraoperative Remifentanil Consumption [Time frame: During surgery]
  • Time to First Rescue Analgesic Requirement [Time frame: First 24 postoperative hours]
  • Rescue Analgesic Consumption [Time frame: First 24 postoperative hours]
  • Block-Related and Opioid-Related Complications [Time frame: First 24 postoperative hours]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 75 years
  • ASA physical status I, II, or III
  • Scheduled for elective arthroscopic shoulder surgery under general anesthesia
  • Provision of written informed consent

Exclusion criteria

  • Refusal to participate in the study
  • Coagulopathy
  • Current anticoagulant therapy
  • Infection at the block site
  • Previous surgery involving the planned block site
  • Known allergy or history of toxicity to local anesthetics
  • Hepatic failure
  • Renal failure
  • Uncontrolled diabetes mellitus
  • Cognitive impairment or mental disability preventing reliable assessment
  • Chronic opioid use or ongoing chronic pain treatment
  • Pregnancy, suspected pregnancy, or breastfeeding
  • Chronic pulmonary disease (e.g., COPD or asthma)
  • Failed block

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Bursa City Hospital — Bursa

Identifiers

NCT: NCT07668648 · 26-AKD-92 · 26-AKD-92

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗