NCT06906458

Brief Summary

In this study, the effect of paresthesia occurring during the interscalene block procedure on the incidence of postoperative neurological symptoms will be investigated. Paresthesia is defined as an abnormal sensation described as "tingling, pinprick, severe pain, or an electric feeling in the arm." The status of postoperative neurological symptoms in patients at the end of the block's effective duration will be assessed through phone interviews, evaluating symptoms such as arm numbness, tingling, abnormal sensations, pain, and weakness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

March 25, 2025

Last Update Submit

November 14, 2025

Conditions

Interscalene BlockPostoperative Pain

Keywords

Interscalene blockParesthesiaPostoperative neurological symptoms

Outcome Measures

Primary Outcomes (1)

  • Paresthesia incidence

    Paresthesia is considered an abnormal sensation described as "tingling, pinprick, severe pain, or an electric feeling in the arm." When paresthesia occurs, the block procedure will be halted, and the needle will be redirected; local anesthetic will not be administered until the paresthesia resolves, and the occurrence of paresthesia will be recorded.

    Perioperative time

Secondary Outcomes (12)

  • Incidence of postoperative neurological symptoms

    30 days

  • Postoperative pain

    36 hours

  • Duration of block effectiveness

    36 hours

  • Postoperative nausea and vomiting

    36 hours

  • Rescue analgesic requirement

    36 hours

  • +7 more secondary outcomes

Study Arms (2)

Paresthesia

Patients experiencing paresthesia during the interscalene nerve block

Other: Paresthesia

No paresthesia

Patients not experiencing paresthesia during the interscalene nerve block

Other: No paresthesia

Interventions

ParesthesiaOTHER

Patients experiencing paresthesia during the interscalene nerve block

Paresthesia
No paresthesiaOTHER

Patients not experiencing paresthesia during the interscalene nerve block

No paresthesia

Eligibility Criteria

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

The study will include patients aged 18-65 years with ASA physical status I or II who are planned to undergo interscalene nerve block for analgesia prior to arthroscopic shoulder surgery in the beach chair position under general anesthesia.

You may qualify if:

  • ASA physical status I to II
  • Age range of 18-65 years
  • Patients planned for interscalene nerve block for analgesia prior to arthroscopic shoulder surgery in the beach chair position under general anesthesia

You may not qualify if:

  • body mass index \>35 kg/m²)
  • history of drug use
  • Patient's refusal to participate in the study
  • Psychiatric disorders
  • Central nervous system diseases
  • Vestibular disorders
  • Presence of diabetes, neuropathy, and paralysis
  • Pregnancy
  • Open shoulder surgery
  • Allergy to local anesthetics
  • Coagulopathy
  • Severe thrombocytopenia
  • Infection at the puncture site
  • Pre-existing neuropathy in the limb to be operated on
  • Use of opioid and antiemetic medications before surgery
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeParesthesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSomatosensory DisordersSensation DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation specialist doctor

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 2, 2025

Study Start

April 11, 2025

Primary Completion

September 15, 2025

Study Completion

October 20, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)