Shoulder PainNCT06225089
Effect of Pericapsular Nerve Block on the Quality of Recovery After Shoulder Arthroscopy
A study testing pericapsuler nerve block in people with Shoulder Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Shoulder arthroscopy surgery is one of the most common orthopedic surgical procedures. Participants experience severe pain after shoulder arthroscopy surgery. This causes the use of high amounts of opioids, delays healing, causes bleeding in the surgical area, and can cause physiological disorders by increasing the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- pericapsuler nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jan 2024to 15 Apr 2024
- 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 who will have unilateral shoulder arthroscopy
- Patients who will receive general anesthesia
- Patients aged 18-65
- Patients with ASAI-III
- in the hospital for at least 24 hours postoperatively
Who cannot join
- Patients who do not want to give consent
- Patients for whom regional anesthesia is contraindicated
- Patients with ASA IV and above
- Patients with confusion
- Patients with a bad bleeding profile using anticoagulants
- Patients with infection in the area to be treated
- Emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Shoulder arthroscopy surgery is one of the most common orthopedic surgical procedures. Participants experience severe pain after shoulder arthroscopy surgery. This causes the use of high amounts of opioids, delays healing, causes bleeding in the surgical area, and can cause physiological disorders by increasing the stress response. Multiple studies have been conducted for analgesic purposes in shoulder surgery. Tran et al., posterior to the glenohumeral joint of the superior part of the suprascapular nerve, posterior inferior part of the posterior branch of the axillary nerve, anterior superior part of subscapularis superior branch, anterior claimed that the axillary nerve innervates the inferior part. In their case report, reported that the pericapsular nerve block (PENG) applied to participants undergoing shoulder surgery provided postoperative analgesia for 16-24 hours pericapsuler nerve block, which is generally applied in hip surgeries, can be applied in shoulder surgery, but there is no large-scale study on pericapsuler nerve block in shoulder surgery, and there is still unknown whether there is a relationship between the pericapsuler nerve block to be applied and the quality of postoperative recovery. Recovery after surgery and anesthesia is complex.
Read the detailed description
Shoulder arthroscopy surgery is one of the most common orthopedic surgical procedures. Participants experience severe pain after shoulder arthroscopy surgery. This causes the use of high amounts of opioids, delays healing, causes bleeding in the surgical area, and can cause physiological disorders by increasing the stress response. Multiple studies have been conducted for analgesic purposes in shoulder surgery. The axillary nerve is said to supply nerves to the inferior part of the suprascapular nerve, the posterior inferior part of the posterior branch of the axillary nerve, and the anterior superior part of the subscapularis superior branch. The study was done posterior to the glenohumeral joint. In their case report reported that the pericapsular nerve block (PENG) applied to participants undergoing shoulder surgery provided postoperative analgesia for 16-24 hours. The block, which is generally applied in hip surgeries, can be applied in shoulder surgery, but there is no large-scale study on the pericapsuler nerve block in shoulder surgery, and still unknown whether there is a relationship between the pericapsuler nerve block applied and the quality of postoperative recovery. Recovery after surgery and anesthesia is complex.
Application of the pericapsuler nerve block will provide better postoperative recovery and recovery scores in participants who will undergo shoulder arthroscopy surgery. The primary aim of this study is to evaluate the effectiveness of pericapsuler nerve block on postoperative recovery and recovery quality after shoulder arthroscopy surgery using the quality of recovery-15 questionnaire.
The secondery aim this study is to postoperatively immobilize and move numeric rating scale in participants undergoing shoulder arthroscopy surgery in which pericapsuler nerve block will be applied, the number of participants needing first-rescue analgesia, the time to first-rescue analgesia, and postoperative To evaluate complications, the number of patients in need of antiemetics, and patient satisfaction.
- Conditions
- Shoulder Pain
- Being tested
- pericapsuler nerve block
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pericapsuler nerve blockDrug
-Ultrasound Guided pericapsuler nerve block: will be externally rotated and abducted to 45 degrees. The shoulder area will be sterilized with povidone-iodine. High-frequency linear ultrasound perpendicularly between the coracoid and the humeral head probe. The deltoid muscle, subscapular muscle and tendon, and humeral head will be identified on the ultrasound screen. With the in-plane technique, a 22 gauge, 50 millimeter (mm) simplex A peripheral nerve block needle will be used. After passing the deltoid muscle, the needle will contact the tendon of the subscapularis muscle. The needle will be slightly withdrawn and directed between the deltoid muscle and the tendon of the subscapularis muscle and a local injection consisting of will be applied.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | All patients will receive routine monitoring ( ECG monitoring, SpO2, noninvasive blood pressure, and EtCO2) and routine anesthesia management. 20 gauge to patients IV Cannulation will be provided and isotonic fluid will be started according to the fluid calculation. General anesthesia induction 1mg midazolam IV, 2 mg/kg propofol IV, 1.5 mcg /kg fentanyl IV, 0.6 mg/kg rocuronium It will be done by giving IV. Patients will be intubated and the minimum amount of anesthesia required for maintenance alveolar Sevoflurane + 50% oxygen + 50% air will be given so that the concentration (MAC) value is 1 and 0.05 mcg/kg/min. remifentanil infusion will begin. The patients will then be released to the surgical team. After the surgical procedure is completed, all patients are given IV paracetamol 1 g 3x1, IV tenoxicam 20 mg 2x1, and IV dexamethasone 8mg will be administered 1x1. All patients will be administered IV 1mg/kg tramadol as rescue analgesic when NRS is 3 or above |
| pericapsuler nerve block group | Active comparator | all patients are given IV paracetamol 1 g 3x1, iv tenoxicam 20 mg 2x1, and IV dexmethasone 8mg will be administered 1x1. Patients in Group P will also receive a pericapsuler nerve block. All patients will be administered IV 1mg/kg tramadol as rescue analgesic when NRS is 3 or above. 4mg IV to all patients with nausea and vomiting Ondansetron will be administered. Once patients are extubated, they will be transferred to the postanesthetic care unit (PACU) for observation. Receives: Drug: pericapsuler nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery-15T
The primary evaluation criteria will be the recording of Quality of recovery-15 scores, which indicate the quality of recovery of patients before and 24 hours after surgery. QoR = -15 (0-150; 0 = lowest degree of satisfaction, 150 = highest degree of satisfaction).
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start26 Jan 2024
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Halit Satici, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225089
- Sponsor's protocol ID
- pericapsüler nerve block
- Status last verified
- Apr 2024
- First submitted
- 9 Dec 2023
- Last updated
- 16 Apr 2024
- 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pericapsular Nerve Block on the Quality of Recovery After Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT06225089
- Acronym / sponsor ID
- pericapsüler nerve block
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 25 Jan 2024 (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.
Shoulder arthroscopy surgery is one of the most common orthopedic surgical procedures. Participants experience severe pain after shoulder arthroscopy surgery. This causes the use of high amounts of opioids, delays healing, causes bleeding in the surgical area, and can cause physiological disorders by increasing the stress response. Multiple studies have been conducted for analgesic purposes in shoulder surgery. Tran et al., posterior to the glenohumeral joint of the superior part of the suprascapular nerve, posterior inferior part of the posterior branch of the axillary nerve, anterior superior part of subscapularis superior branch, anterior claimed that the axillary nerve innervates the inferior part. In their case report, reported that the pericapsular nerve block (PENG) applied to participants undergoing shoulder surgery provided postoperative analgesia for 16-24 hours pericapsuler nerve block, which is generally applied in hip surgeries, can be applied in shoulder surgery, but there is no large-scale study on pericapsuler nerve block in shoulder surgery, and there is still unknown whether there is a relationship between the pericapsuler nerve block to be applied and the quality of postoperative recovery. Recovery after surgery and anesthesia is complex.
Detailed description
Shoulder arthroscopy surgery is one of the most common orthopedic surgical procedures. Participants experience severe pain after shoulder arthroscopy surgery. This causes the use of high amounts of opioids, delays healing, causes bleeding in the surgical area, and can cause physiological disorders by increasing the stress response. Multiple studies have been conducted for analgesic purposes in shoulder surgery. The axillary nerve is said to supply nerves to the inferior part of the suprascapular nerve, the posterior inferior part of the posterior branch of the axillary nerve, and the anterior superior part of the subscapularis superior branch. The study was done posterior to the glenohumeral joint. In their case report reported that the pericapsular nerve block (PENG) applied to participants undergoing shoulder surgery provided postoperative analgesia for 16-24 hours. The block, which is generally applied in hip surgeries, can be applied in shoulder surgery, but there is no large-scale study on the pericapsuler nerve block in shoulder surgery, and still unknown whether there is a relationship between the pericapsuler nerve block applied and the quality of postoperative recovery. Recovery after surgery and anesthesia is complex.
Application of the pericapsuler nerve block will provide better postoperative recovery and recovery scores in participants who will undergo shoulder arthroscopy surgery. The primary aim of this study is to evaluate the effectiveness of pericapsuler nerve block on postoperative recovery and recovery quality after shoulder arthroscopy surgery using the quality of recovery-15 questionnaire.
The secondery aim this study is to postoperatively immobilize and move numeric rating scale in participants undergoing shoulder arthroscopy surgery in which pericapsuler nerve block will be applied, the number of participants needing first-rescue analgesia, the time to first-rescue analgesia, and postoperative To evaluate complications, the number of patients in need of antiemetics, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –All patients will receive routine monitoring ( ECG monitoring, SpO2, noninvasive blood pressure, and EtCO2) and routine anesthesia management. 20 gauge to patients IV Cannulation will be provided and isotonic fluid will be started according to the fluid calculation. General anesthesia induction 1mg midazolam IV, 2 mg/kg propofol IV, 1.5 mcg /kg fentanyl IV, 0.6 mg/kg rocuronium It will be done by giving IV. Patients will be intubated and the minimum amount of anesthesia required for maintenance alveolar Sevoflurane + 50% oxygen + 50% air will be given so that the concentration (MAC) value is 1 and 0.05 mcg/kg/min. remifentanil infusion will begin. The patients will then be released to the surgical team. After the surgical procedure is completed, all patients are given IV paracetamol 1 g 3x1, IV tenoxicam 20 mg 2x1, and IV dexamethasone 8mg will be administered 1x1. All patients will be administered IV 1mg/kg tramadol as rescue analgesic when NRS is 3 or above |
| pericapsuler nerve block group | Active comparator | Drug: pericapsuler nerve blockall patients are given IV paracetamol 1 g 3x1, iv tenoxicam 20 mg 2x1, and IV dexmethasone 8mg will be administered 1x1. Patients in Group P will also receive a pericapsuler nerve block. All patients will be administered IV 1mg/kg tramadol as rescue analgesic when NRS is 3 or above. 4mg IV to all patients with nausea and vomiting Ondansetron will be administered. Once patients are extubated, they will be transferred to the postanesthetic care unit (PACU) for observation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who will have unilateral shoulder arthroscopy
- Patients who will receive general anesthesia
- Patients aged 18-65
- Patients with ASAI-III
- in the hospital for at least 24 hours postoperatively
Key exclusion criteria (7 listed)
- Patients who do not want to give consent
- Patients for whom regional anesthesia is contraindicated
- Patients with ASA IV and above
- Patients with confusion
- Patients with a bad bleeding profile using anticoagulants
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 |
|---|---|---|
| pericapsuler nerve block-Ultrasound Guided pericapsuler nerve block: will be externally rotated and abducted to 45 degrees. The shoulder area will be sterilized with povidone-iodine. High-frequency linear ultrasound perpendicularly between the coracoid and the humeral head probe. The deltoid muscle, subscapular muscle and tendon, and humeral head will be identified on the ultrasound screen. With the in-plane technique, a 22 gauge, 50 millimeter (mm) simplex A peripheral nerve block needle will be used. After passing the deltoid muscle, the needle will contact the tendon of the subscapularis muscle. The needle will be slightly withdrawn and directed between the deltoid muscle and the tendon of the subscapularis muscle and a local injection consisting of will be applied. | Drug | pericapsuler nerve block group |
Primary outcome
quality of recovery-15T
Time frame: One day
The primary evaluation criteria will be the recording of Quality of recovery-15 scores, which indicate the quality of recovery of patients before and 24 hours after surgery. QoR = -15 (0-150; 0 = lowest degree of satisfaction, 150 = highest degree of satisfaction).
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 16 Apr 2024.
- 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 pericapsuler nerve block in people with Shoulder Pain, run by Konya City Hospital 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 5 inclusion and 7 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 16 Apr 2024. 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?
quality of recovery-15T (time frame: One day). 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 16 Apr 2024.