Impact of Paresthesia on Postoperative Neurological Symptoms

NCT ID: NCT06906458

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-11
• Study Completion Date: 2025-10-20

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.

Detailed Description

Our study includes patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I or II who undergo interscalene nerve block prior to arthroscopic shoulder surgery under general anesthesia. All patients will be fasting according to standard protocol. During the preoperative period, patients' age, comorbidities, gender, body mass index (BMI), ASA scores, and preoperative Quality of Recovery-15 (QoR-15) scores will be recorded.

In the operating room, possible complications related to the block (paresthesia, Horner's syndrome, dyspnea, hoarseness) will be monitored in the preoperative area. During the intraoperative period, data such as pulse, blood pressure, infusion fluids, intraoperative remifentanil requirements, anesthesia duration, and surgical time will be recorded.

In the postoperative period, postoperative pain status, block duration, postoperative nausea and vomiting, need for rescue analgesics and antiemetics, and QoR-15 scores on the first day will be assessed in the recovery room and ward. Additionally, postoperative neurological symptoms and QoR-15 scores will be followed via telephone on the 3rd, 7th, 10th, and 30th days after discharge.

For patients developing postoperative pain, pain intensity will be evaluated using an 11-point numeric rating scale, where 0 indicates no symptoms and 10 represents maximum severity.

Conditions

Interscalene Block; Postoperative Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Paresthesia

Patients experiencing paresthesia during the interscalene nerve block

Paresthesia

Intervention Type: OTHER

Patients experiencing paresthesia during the interscalene nerve block

No paresthesia

Patients not experiencing paresthesia during the interscalene nerve block

No paresthesia

Intervention Type: OTHER

Patients not experiencing paresthesia during the interscalene nerve block

Interventions

Paresthesia

Patients experiencing paresthesia during the interscalene nerve block

Intervention Type: OTHER

No paresthesia

Patients not experiencing paresthesia during the interscalene nerve block

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Use of dexamethasone
• Lung disease
• Low baseline oxygen saturation
• Patients who cannot cooperate in the postoperative period (e.g., mental retardation, delirium, language acquisition deficiency, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Gökhan Erdem

Anesthesiology and Reanimation specialist doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Paresthesia

Identifier Type: -

Identifier Source: org_study_id