Interscalene BlockNCT06906458
Impact of Paresthesia on Postoperative Neurological Symptoms
An observational study of Interscalene Block and Postoperative Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interscalene Block, Postoperative Pain
- What is being tested?
- Paresthesia and No paresthesia
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Apr 2025to 20 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include patients aged 18-65 years with ASA physical status I or II who are planned to undergo interscalene nerve block for analgesia prior to arthroscopic shoulder surgery in the beach chair position under general anesthesia.
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, Çankaya, 06800
About this study
Official title: Effect of Paresthesia During Interscalene Block Procedure on the Incidence of Postoperative Neurological Symptoms: A Prospective Observational Clinical Study
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.
Read the 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
- Being tested
- Paresthesia, No paresthesia
- Keywords
- Interscalene block, Paresthesia, Postoperative neurological symptoms
- Medical subject headings
- Pain, Postoperative, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParesthesiaOther
Patients experiencing paresthesia during the interscalene nerve block
No paresthesiaOther
Patients not experiencing paresthesia during the interscalene nerve block
| Study group | Role | What they receive |
|---|---|---|
| Paresthesia | Patients experiencing paresthesia during the interscalene nerve block Receives: Other: Paresthesia | |
| No paresthesia | Patients not experiencing paresthesia during the interscalene nerve block Receives: Other: No paresthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paresthesia incidence
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.
Measured: Perioperative time
Secondary outcomes (12)
Incidence of postoperative neurological symptoms
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.
Measured: 30 days
Postoperative pain
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.
Measured: 36 hours
Duration of block effectiveness
The time (in minutes) until the patient reports a significant increase in pain after the block
Measured: 36 hours
Postoperative nausea and vomiting
Significant nausea, vomiting, and/or need for rescue antiemetics
Measured: 36 hours
Rescue analgesic requirement
Number of additional analgesic applications
Measured: 36 hours
Rescue antiemetic requirement
Number of additional antiemetic applications
Measured: 36 hours
intraoperative opioid requirement
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.
Measured: intraoperative time
Duration of stay in the recovery room
The time from arrival in the recovery room until the discharge criteria are met
Measured: 2 hours
Quality of Recovery-15 (QoR-15) scores
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.
Measured: 30 days
Horner's syndrome
Miosis and ptosis of the ipsilateral pupil during the perioperative period.
Measured: Perioperative/Periprocedural
Dyspnea
Breathing difficulty as described by the patient during the perioperative period.
Measured: Perioperative/Periprocedural
Hoarseness
Voice changes described by the patient during the perioperative period
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start11 Apr 2025
- Primary completion15 Sep 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interscalene BlockStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Erdem, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906458
- Sponsor's protocol ID
- Paresthesia
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paresthesia During Interscalene Block Procedure on the Incidence of Postoperative Neurological Symptoms: A Prospective Observational Clinical Study
- ClinicalTrials.gov ID
- NCT06906458
- Acronym / sponsor ID
- Paresthesia
- Conditions
- Interscalene Block, Postoperative Pain
- Keywords
- Interscalene block, Paresthesia, Postoperative neurological symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paresthesia | – | Other: ParesthesiaPatients experiencing paresthesia during the interscalene nerve block |
| No paresthesia | – | Other: No paresthesiaPatients not experiencing paresthesia during the interscalene nerve block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients aged 18-65 years with ASA physical status I or II who are planned to undergo interscalene nerve block for analgesia prior to arthroscopic shoulder surgery in the beach chair position under general anesthesia.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- body mass index >35 kg/m²)
- history of drug use
- Patient's refusal to participate in the study
- Psychiatric disorders
- Central nervous system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParesthesiaPatients experiencing paresthesia during the interscalene nerve block | Other | Paresthesia |
| No paresthesiaPatients not experiencing paresthesia during the interscalene nerve block | Other | No paresthesia |
Primary outcome
Paresthesia incidence
Time frame: 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.
12 secondary outcomes
Incidence of postoperative neurological symptoms
Time frame: 30 days
Postoperative pain
Time frame: 36 hours
Duration of block effectiveness
Time frame: 36 hours
Postoperative nausea and vomiting
Time frame: 36 hours
Rescue analgesic requirement
Time frame: 36 hours
Rescue antiemetic requirement
Time frame: 36 hours
intraoperative opioid requirement
Time frame: intraoperative time
Duration of stay in the recovery room
Time frame: 2 hours
Quality of Recovery-15 (QoR-15) scores
Time frame: 30 days
Horner's syndrome
Time frame: Perioperative/Periprocedural
Dyspnea
Time frame: Perioperative/Periprocedural
Hoarseness
Time frame: Perioperative/Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interscalene Block and Postoperative Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paresthesia incidence (time frame: Perioperative time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.