Investigating the effects of tingling sensations during shoulder surgery anesthesia on recovery
Effect of Paresthesia During Interscalene Block Procedure on the Incidence of Postoperative Neurological Symptoms: A Prospective Observational Clinical Study
Ankara City Hospital Bilkent · NCT06906458
This study is testing how tingling sensations during shoulder surgery anesthesia affect recovery and any nerve-related symptoms in patients aged 18 to 65.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent (other) |
| Locations | 1 site (Ankara, Ankara, Çankaya) |
| Trial ID | NCT06906458 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how paresthesia, or abnormal sensations like tingling, during the interscalene block procedure affects the occurrence of postoperative neurological symptoms in patients undergoing arthroscopic shoulder surgery. Patients aged 18-65 with ASA physical status I or II will be monitored for various parameters, including complications during the block, intraoperative data, and postoperative recovery indicators. Follow-up assessments will be conducted through phone interviews to evaluate symptoms such as numbness, tingling, and pain at multiple time points after discharge.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with ASA physical status I or II scheduled for arthroscopic shoulder surgery requiring an interscalene nerve block.
Not a fit: Patients with a body mass index over 35, psychiatric disorders, or pre-existing neuropathy in the limb to be operated on may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of postoperative neurological symptoms and improve pain management strategies following shoulder surgery.
How similar studies have performed: While similar studies have explored postoperative pain management, this specific investigation into paresthesia's impact on neurological symptoms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Ankara, Ankara, Çankaya
- Ankara Bilkent City Hospital — Ankara, Ankara, Çankaya, Turkey (RECRUITING)
Study contacts
- Study coordinator: Ankara BC Hospital
- Email: ankarasehir@saglik.gov.tr
- Phone: 03125526000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Interscalene Block, Postoperative Pain, Interscalene block, Paresthesia, Postoperative neurological symptoms