NCT07483814

Brief Summary

The Importance of Postoperative Analgesia in Shoulder Surgery Shoulder surgery is an orthopedic procedure that can be performed either through open surgery or arthroscopically. Pain following shoulder surgery can lead to adverse outcomes such as decreased functional status, increased consumption of narcotic analgesics, and the development of chronic pain. Therefore, achieving optimal postoperative shoulder analgesia is important not only for patient comfort and satisfaction but also for promoting functional recovery, preventing chronic pain, and reducing the need for narcotic analgesics. Additionally, minimizing the side effects associated with nerve block techniques used for analgesia is crucial for the overall success of the treatment.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Progress76%
Jan 2024Jun 2027

Study Start

First participant enrolled

January 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

July 24, 2025

Last Update Submit

March 17, 2026

Conditions

Keywords

shoulder arthroscopyinterscalene blocksuprascapular blockbrachial plexus

Outcome Measures

Primary Outcomes (1)

  • The analgesic efficacy of interscalene block (ISB) and suprascapular block (SSB) will be compared in patients undergoing shoulder arthroscopy.

    It is a pain intensity assessment system based on the patient indicating a point between 0 (no pain) and 10 (unbearable pain) to describe their pain level.

    the first 48 hours postoperatively

Secondary Outcomes (1)

  • The development of chronic pain following interscalene block (ISB) and suprascapular block (SSB) will be compared in patients undergoing shoulder arthroscopy.

    3 months postoperatively

Other Outcomes (1)

  • The side effects of interscalene block (ISB) and suprascapular block (SSB) will be compared in patients undergoing shoulder arthroscopy.

    the first 48 hours postoperatively

Study Arms (2)

Suprascapular block

For Group I, after the patients were positioned in the sitting posture, reference points were identified based on anatomical landmarks, including the scapular spine and the acromion. A linear ultrasound probe (13-6 MHz) was used to guide the procedure, targeting the suprascapular notch. Under sterile conditions, a 22-gauge × 100 mm needle (Braun® Stimuplex) was advanced, and following negative aspiration, 15 mL of 0.5% bupivacaine was injected.

Other: rescue analgesia

Interscalene block

For Group II, patients were positioned in the supine or semi-sitting position with the head turned to the contralateral side to facilitate access to the lateral aspect of the neck. Following antiseptic skin preparation, a high-frequency linear ultrasound probe (6-13 MHz) was placed transversely on the lateral neck. The C5-C7 nerve roots were identified as hyperechoic structures located between the anterior and middle scalene muscles. Using an in-plane ultrasound-guided approach, a 22-gauge, 50-100 mm nerve block needle was advanced into the interscalene groove. After confirming negative aspiration, 15 mL of 0.5% bupivacaine was administered around the nerve roots.

Other: rescue analgesia

Interventions

In the postoperative recovery room, patients with a Numeric Rating Scale (NRS) score of 4 or higher received 100 mg of intravenous tramadol as rescue analgesia. In addition, both groups routinely received 1 g of intravenous paracetamol every 6 hours during their stay in the ward. During ward follow-up, if the NRS score was 4 or higher, 100 mg of intravenous tramadol was administered as needed.

Interscalene blockSuprascapular block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Once suitability is confirmed, detailed information about the work programs is provided in glossary and written form. Random grouping (randomization) and work will be specifically approved after being informed before any process.

You may qualify if:

  • Patients who have provided written informed consent
  • Patients over 18 years of age scheduled for elective shoulder arthroscopy
  • Patients classified as ASA I-II
  • Patients undergoing general anesthesia

You may not qualify if:

  • Patients undergoing shoulder surgery other than arthroscopic procedures (e.g., revision or open surgery)
  • Patients with pre-existing respiratory, cardiac, renal, neurological, or hepatic diseases
  • Presence of neuropathy affecting the brachial plexus
  • Contraindications to peripheral nerve block (e.g., coagulopathy)
  • Known allergy to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan menderesüniversite Hastanesi

Aydin, Efeler, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Durali BAYKA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doktor

Study Record Dates

First Submitted

July 24, 2025

First Posted

March 19, 2026

Study Start

January 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations