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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06906458
Enrollment
120
Registered
2025-04-02
Start date
2025-04-11
Completion date
2025-10-20
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interscalene Block, Postoperative Pain

Keywords

Interscalene block, Paresthesia, Postoperative neurological symptoms

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.

Interventions

OTHERParesthesia

Patients experiencing paresthesia during the interscalene nerve block

OTHERNo paresthesia

Patients not experiencing paresthesia during the interscalene nerve block

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Paresthesia incidencePerioperative timeParesthesia 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

MeasureTime frameDescription
Postoperative pain36 hoursIn 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.
Duration of block effectiveness36 hoursThe time (in minutes) until the patient reports a significant increase in pain after the block
Postoperative nausea and vomiting36 hoursSignificant nausea, vomiting, and/or need for rescue antiemetics
Rescue analgesic requirement36 hoursNumber of additional analgesic applications
Rescue antiemetic requirement36 hoursNumber of additional antiemetic applications
Incidence of postoperative neurological symptoms30 daysthe 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.
Duration of stay in the recovery room2 hoursThe time from arrival in the recovery room until the discharge criteria are met
Quality of Recovery-15 (QoR-15) scores30 daysThe 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 syndromePerioperative/PeriproceduralMiosis and ptosis of the ipsilateral pupil during the perioperative period.
DyspneaPerioperative/PeriproceduralBreathing difficulty as described by the patient during the perioperative period.
HoarsenessPerioperative/PeriproceduralVoice changes described by the patient during the perioperative period
intraoperative opioid requirementintraoperative timeTo 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026