NCT06906458

Impact of Paresthesia on Postoperative Neurological Symptoms

Effect of Paresthesia During Interscalene Block Procedure on the Incidence of Postoperative Neurological Symptoms: A Prospective Observational Clinical Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Paresthesia	Patients experiencing paresthesia during the interscalene nerve block
OTHER	No paresthesia	Patients not experiencing paresthesia during the interscalene nerve block

Timeline

• Start date: 2025-04-11
• Primary completion: 2025-09-15
• Completion: 2025-10-20
• First posted: 2025-04-02
• Last updated: 2025-11-17

Locations

1 site across 1 country: Turkey (Türkiye)