Impact of Paresthesia on Postoperative Neurological Symptoms

Recruiting

• Conditions: Interscalene Block; Postoperative Pain

• Registration Number: NCT06906458
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-31
• Status Verified: 2025-04
• Study First Posted: 2025-04-02
• Study Start: 2025-04-11
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-07-10
• Study Completion: 2025-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Paresthesia incidence	Perioperative time	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative neurological symptoms	30 days	the status of postoperative neurological symptoms will be assessed via telephone by a physician different from the one who performed the block. During the evaluation, symptoms such as arm numbness, tingling, abnormal sensations, pain, and weakness will be considered. Those responding "yes" to any of these symptoms will be classified as patients experiencing postoperative neurological symptoms.
Postoperative nausea and vomiting	36 hours	Significant nausea, vomiting, and/or need for rescue antiemetics
Rescue analgesic requirement	36 hours	Number of additional analgesic applications
Duration of stay in the recovery room	2 hours	The time from arrival in the recovery room until the discharge criteria are met
Quality of Recovery-15 (QoR-15) scores	30 days	The QoR-15 questionnaire consists of 15 questions rated on a scale of 0 to 10, with a total score assessed out of 150. Results are classified as follows: above 135 is considered "excellent," 122-135 is "good," 90-121 is "fair," and below 90 is "poor.
Horner's syndrome	Perioperative/Periprocedural	Miosis and ptosis of the ipsilateral pupil during the perioperative period.
Postoperative pain	36 hours	In the postoperative period, patients will be assessed for pain using a 0-10 Numeric Rating Scale (NRS) at rest at 4, 6, 8, 12, 16, and 18 hours, and at both rest and during movement at 24 and 36 hours to record the highest pain scores. The NRS is a scale used for patients to express their pain levels, where 0 represents the absence of pain and 10 represents the most severe pain.
intraoperative opioid requirement	intraoperative time	To maintain the bispectral index (BIS) between 40-60, remifentanil will be initiated and titrated between 0.05-0.25 mcg/kg/min, taking into account a 20% increase in MAP (mean arterial pressure) compared to the initial value and a 15% increase in heart rate compared to the initial value.
Duration of block effectiveness	36 hours	The time (in minutes) until the patient reports a significant increase in pain after the block
Rescue antiemetic requirement	36 hours	Number of additional antiemetic applications
Dyspnea	Perioperative/Periprocedural	Breathing difficulty as described by the patient during the perioperative period.
Hoarseness	Perioperative/Periprocedural	Voice changes described by the patient during the perioperative period

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Ankara, Çankaya, Turkey