AnesthesiaNCT06883279
Effect of Interscalene Block Methods on Rebound Pain
A study testing Intraplexus and Extraplexus in people with Anesthesia and Pain, Shoulder, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this study, the hypothesis that local anesthesia, not directly injected into the nerve root, may reduce the incidence of rebound pain in the interscalene block with an extraplexus approach during arthroscopic shoulder surgeries will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Pain, Shoulder, Pain, Postoperative
- What is being tested?
- Intraplexus and Extraplexus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2025to 20 Oct 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 18-65 years.
- Patients with ASA physical status I or II.
- Patients planned for arthroscopic shoulder surgery in the lateral decubitus position with interscalene nerve block.
Who cannot join
- Patients who do not consent to participate in the study.
- Block failure.
- Language acquisition deficiency.
- Obesity (body mass index > 35 kg/m²).
- Diabetes.
- Psychiatric disorders.
Show all 21Show fewer
- Central nervous system diseases.
- Vestibular diseases.
- Presence of neuropathy and paralysis.
- Pregnancy.
- Previous open shoulder surgery.
- Allergy to local anesthetics.
- Coagulopathy.
- Severe thrombocytopenia.
- Infection at the puncture site.
- Pre-existing neuropathy in the limb to be operated.
- Use of dexamethasone.
- Use of opioid and antiemetic medications before surgery.
- Severe cardiopulmonary disease.
- Low baseline oxygen saturation.
- Conditions that prevent cooperation in the postoperative period (e.g., mental retardation, delirium).
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 Intraplexus and Extraplexus Interscalene Block Approaches on the Incidence of Rebound Pain in Arthroscopic Shoulder Surgery: A Prospective, Randomized, Double-Blind Clinical Study
In this study, the hypothesis that local anesthesia, not directly injected into the nerve root, may reduce the incidence of rebound pain in the interscalene block with an extraplexus approach during arthroscopic shoulder surgeries will be investigated. Rebound pain is defined as a short-term but severe pain before and after the resolution of the interscalene block and will be evaluated using the Numerical Rating Scale (NRS) (NRS ≥ 7).
Read the detailed description
The study will include patients aged 18-65 years, with an American Society of Anesthesiologists (ASA) physical status of I or II, scheduled for arthroscopic shoulder surgery in the lateral decubitus position, accompanied by interscalene nerve block performed by the same surgeon. Patient characteristics (age, gender, body mass index, etc.), block procedure duration, number of needle passes, onset time of sensory block, onset time of motor block, and possible complications related to the block (paresthesia, Horner's syndrome, dyspnea, hoarseness), postoperative nausea and vomiting (PONV) status, and Quality of Recovery-15 (QoR-15) scores on the preoperative first day and postoperative days 1 and 7 will be recorded. The primary outcome parameter will be the incidence of rebound pain. Rebound pain will be defined as a short-term but severe pain before and after the resolution of the interscalene block, assessed using the Numerical Rating Scale (NRS) (NRS ≥ 7). Secondary outcomes will include the number of needle passes, block application time, onset time of sensory block, onset time of motor block, intraoperative dexmedetomidine requirement, duration of block effectiveness, postoperative pain, PONV, need for rescue analgesics, incidence of paresthesia and Horner's syndrome, dyspnea, hoarseness, duration of stay in the recovery room, duration of rebound pain, and postoperative Quality of Recovery-15 (QoR-15) scores.
- Conditions
- Anesthesia, Pain, Shoulder, Pain, Postoperative
- Being tested
- Intraplexus, Extraplexus
- Keywords
- Anesthesia, Interscalene block, Rebound pain
- Medical subject headings
- Shoulder Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntraplexusOther
The block needle will be advanced from the middle scalene muscle in a posterior-anterior direction and advanced between the C5-C6 nerve roots and the injection will be performed
ExtraplexusOther
The block needle will first be advanced above the C5 nerve root and towards the anterior part of the brachial plexus and 10 ml of local anesthetic will be injected. Then, the needle will be withdrawn to the posterior surface of the brachial plexus and 10 ml of local anesthetic will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Intraplexus approach in interscalene block | Active comparator | The block needle will be advanced from the middle scalene muscle in a posterior-anterior direction and advanced between the C5-C6 nerve roots and the injection will be performed Receives: Other: Intraplexus |
| Extraplexus approach in interscalene block | Active comparator | The block needle will first be advanced above the C5 nerve root and towards the anterior part of the brachial plexus and 10 ml of local anesthetic will be injected. Then, the needle will be withdrawn to the posterior surface of the brachial plexus and 10 ml of local anesthetic will be administered. Receives: Other: Extraplexus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebound pain
Pain will be evaluated using the 0-10 Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. Rebound pain will be defined as a short-term but severe pain occurring before and after the resolution of the interscalene block (NRS ≥ 7).
Measured: 36 hours
Secondary outcomes (16)
Number of needle passes
Number of times the needle is withdrawn and reinserted
Measured: During the block procedure time
Block performance time
Time from the placement of the block needle to the completion of local anesthetic injection (minutes)
Measured: During the block procedure time
Rescue analgesic
Pain will be evaluated using the 0-10 Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. During the postoperative period, if NRS ≥ 4 occurs, 100 mg of tramadol will be administered intravenously. This situation will be defined as the need for rescue analgesia.
Measured: 36 hours
Duration of rebound pain
Pain will be evaluated using the 0-10 Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. Rebound pain will be defined as a short-term but severe pain occurring before and after the resolution of the interscalene block (NRS ≥ 7). The duration of rebound pain experienced by patients will be recorded in minutes based on the time the pain started and ended, as assessed in a questionnaire directed at the patients.
Measured: 36 hours
Onset of sensory block
Duration (minutes) during which there is touch sensation but no pain in the relevant dermatomal areas in the Pin-Prick test.
Measured: Preoperative time
Onset of motor block
Duration (minutes) during which motor strength is reduced, but the arm is still movable.
Measured: Preoperative time
Duration of block effectiveness
Time (minutes) until the patient reports a significant increase in pain after the block.
Measured: 36 hours
PONV
Significant nausea, vomiting, and/or need for rescue antiemetics.
Measured: 36 hours
Paresthesia
Observations during the block procedure of 'needle prick, tingling, or electric shock radiating to the arm
Measured: During the block procedure time
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
Intraoperative use of dexmedetomidine
Ramsey Sedation Scale is a tool used to assess the sedation levels of patients, and it scores from 1 to 6. A score of 1 indicates that the patient is awake, agitated, and very active; a score of 2 indicates that the patient is awake but slightly agitated. A score of 3 indicates that the patient is awake but calm, while a score of 4 indicates that the patient responds but has decreased alertness. A score of 5 indicates that the patient is not awake but responds to stimulation; a score of 6 indicates that the patient is not awake and does not respond to stimuli. In the study, the necessary amount of dexmedetomidine (μg) will be recorded for patients to fall within the 3-4 range on the Ramsey Sedation Scale.
Measured: Intraoperative time
Pain scores
Evaluated using a 0-10 Numerical Rating Scale (NRS), where zero represents no pain and ten represents the worst pain imaginable.
Measured: 36 hours
Duration of stay in the recovery room
Time from arrival in the recovery room to the point when discharge criteria are met
Measured: up to 2 hours post surgery
Quality of recovery
The Quality of Recovery-15 (QoR-15) questionnaire consists of 15 questions rated on a scale of 0-10, with a total score evaluated out of 150. Results are classified as 'excellent' for scores above 135, 'good' for scores between 122-135, 'moderate' for scores between 90-121, and 'poor' for scores below 90.
Measured: Preoperative day 1, postoperative days 1 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start20 Mar 2025
- Primary completion10 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 AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 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
- NCT06883279
- Sponsor's protocol ID
- Rebound pain
- Status last verified
- Nov 2025
- First submitted
- 9 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 Intraplexus and Extraplexus Interscalene Block Approaches on the Incidence of Rebound Pain in Arthroscopic Shoulder Surgery: A Prospective, Randomized, Double-Blind Clinical Study
- ClinicalTrials.gov ID
- NCT06883279
- Acronym / sponsor ID
- Rebound pain
- Conditions
- Anesthesia, Pain, Shoulder, Pain, Postoperative
- Keywords
- Anesthesia, Interscalene block, Rebound pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 19 Mar 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 hypothesis that local anesthesia, not directly injected into the nerve root, may reduce the incidence of rebound pain in the interscalene block with an extraplexus approach during arthroscopic shoulder surgeries will be investigated. Rebound pain is defined as a short-term but severe pain before and after the resolution of the interscalene block and will be evaluated using the Numerical Rating Scale (NRS) (NRS ≥ 7).
Detailed description
The study will include patients aged 18-65 years, with an American Society of Anesthesiologists (ASA) physical status of I or II, scheduled for arthroscopic shoulder surgery in the lateral decubitus position, accompanied by interscalene nerve block performed by the same surgeon. Patient characteristics (age, gender, body mass index, etc.), block procedure duration, number of needle passes, onset time of sensory block, onset time of motor block, and possible complications related to the block (paresthesia, Horner's syndrome, dyspnea, hoarseness), postoperative nausea and vomiting (PONV) status, and Quality of Recovery-15 (QoR-15) scores on the preoperative first day and postoperative days 1 and 7 will be recorded. The primary outcome parameter will be the incidence of rebound pain. Rebound pain will be defined as a short-term but severe pain before and after the resolution of the interscalene block, assessed using the Numerical Rating Scale (NRS) (NRS ≥ 7). Secondary outcomes will include the number of needle passes, block application time, onset time of sensory block, onset time of motor block, intraoperative dexmedetomidine requirement, duration of block effectiveness, postoperative pain, PONV, need for rescue analgesics, incidence of paresthesia and Horner's syndrome, dyspnea, hoarseness, duration of stay in the recovery room, duration of rebound pain, and postoperative Quality of Recovery-15 (QoR-15) scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraplexus approach in interscalene block | Active comparator | Other: IntraplexusThe block needle will be advanced from the middle scalene muscle in a posterior-anterior direction and advanced between the C5-C6 nerve roots and the injection will be performed |
| Extraplexus approach in interscalene block | Active comparator | Other: ExtraplexusThe block needle will first be advanced above the C5 nerve root and towards the anterior part of the brachial plexus and 10 ml of local anesthetic will be injected. Then, the needle will be withdrawn to the posterior surface of the brachial plexus and 10 ml of local anesthetic will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-65 years.
- Patients with ASA physical status I or II.
- Patients planned for arthroscopic shoulder surgery in the lateral decubitus position with interscalene nerve block.
Key exclusion criteria (21 listed)
- Patients who do not consent to participate in the study.
- Block failure.
- Language acquisition deficiency.
- Obesity (body mass index > 35 kg/m²).
- Diabetes.
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 |
|---|---|---|
| IntraplexusThe block needle will be advanced from the middle scalene muscle in a posterior-anterior direction and advanced between the C5-C6 nerve roots and the injection will be performed | Other | Intraplexus approach in interscalene block |
| ExtraplexusThe block needle will first be advanced above the C5 nerve root and towards the anterior part of the brachial plexus and 10 ml of local anesthetic will be injected. Then, the needle will be withdrawn to the posterior surface of the brachial plexus and 10 ml of local anesthetic will be administered. | Other | Extraplexus approach in interscalene block |
Primary outcome
Rebound pain
Time frame: 36 hours
Pain will be evaluated using the 0-10 Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. Rebound pain will be defined as a short-term but severe pain occurring before and after the resolution of the interscalene block (NRS ≥ 7).
16 secondary outcomes
Number of needle passes
Time frame: During the block procedure time
Block performance time
Time frame: During the block procedure time
Rescue analgesic
Time frame: 36 hours
Duration of rebound pain
Time frame: 36 hours
Onset of sensory block
Time frame: Preoperative time
Onset of motor block
Time frame: Preoperative time
Duration of block effectiveness
Time frame: 36 hours
PONV
Time frame: 36 hours
Paresthesia
Time frame: During the block procedure time
Horner's syndrome
Time frame: Perioperative/Periprocedural
Dyspnea
Time frame: Perioperative/Periprocedural
Hoarseness
Time frame: Perioperative/Periprocedural
Intraoperative use of dexmedetomidine
Time frame: Intraoperative time
Pain scores
Time frame: 36 hours
Duration of stay in the recovery room
Time frame: up to 2 hours post surgery
Quality of recovery
Time frame: Preoperative day 1, postoperative days 1 and 7.
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?
A study testing Intraplexus and Extraplexus in people with Anesthesia and Pain, Shoulder, 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 21 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?
Rebound pain (time frame: 36 hours). 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.