NCT07668648

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

June 17, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 25, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 17, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

Interscalene Brachial Plexus BlockSerratus Posterior Superior Intercostal Plane BlockRegional AnesthesiaUltrasound-Guided Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Total Opioid Consumption During the First 24 Postoperative Hours

    Comparison of total postoperative opioid consumption between the interscalene brachial plexus block group and the serratus posterior superior intercostal plane block group during the first 24 hours after surgery.

    24 hours after surgery

Secondary Outcomes (6)

  • Postoperative Pain Scores

    0, 2, 4, 8, 16, and 24 hours after surgery

  • Quality of Recovery (QoR-15)

    24 hours after surgery

  • Intraoperative Remifentanil Consumption

    During surgery

  • Time to First Rescue Analgesic Requirement

    First 24 postoperative hours

  • Rescue Analgesic Consumption

    First 24 postoperative hours

  • +1 more secondary outcomes

Study Arms (2)

Interscalene Brachial Plexus Block Group

EXPERIMENTAL

Participants receive an ultrasound-guided interscalene brachial plexus block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery.

Procedure: Interscalene Brachial Plexus BlockDrug: Bupivacaine

Serratus Posterior Superior Intercostal Plane Block Group

EXPERIMENTAL

Participants receive an ultrasound-guided serratus posterior superior intercostal plane block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery.

Procedure: Serratus Posterior Superior Intercostal Plane BlockDrug: Bupivacaine

Interventions

Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.

Interscalene Brachial Plexus Block Group

Ultrasound-guided serratus posterior superior intercostal plane block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.

Serratus Posterior Superior Intercostal Plane Block Group

Bupivacaine administered for ultrasound-guided regional anesthesia block.

Interscalene Brachial Plexus Block GroupSerratus Posterior Superior Intercostal Plane Block Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mürsel Ekinci

    University of Health Sciences, Bursa Faculty of Medicine, Bursa City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mürsel Ekinci, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either an ultrasound-guided interscalene brachial plexus block or a serratus posterior superior intercostal plane block before arthroscopic shoulder surgery.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 25, 2026

Study Start

June 25, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations