Postoperative PainNCT05940454
Pericapsular Nerve Group Block in Shoulder Surgery
A study testing Pericapsular nerve group block in people with Postoperative Pain, run by Selcuk University.
Trial summary
Dear Patient, You have been scheduled for shoulder surgery by your surgeon. This surgery is performed under general anesthesia, that is, by putting the patient to sleep, and then moderate or severe pain is experienced. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pericapsular nerve group block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Nov 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- coagulopathy,
- neuropathy,
- use of anticoagulants,
- severe diabetes mellitus,
- local anesthetic and/or opioid allergy or sensitivity,
- a history of chronic pain,
Show all 14Show fewer
- pre-existing psychiatric illness,
- can't understand pain scoring,
- Body mass index greater than 35 kg/m2,
- There is an infection in the body area to be blocked,
- Continuing follow-up and treatment in the intensive care unit,
- open shoulder surgery
- do not approve the informed consent form
- pregnant
About this study
Official title: Efficacy of Pericapsular Nerve Group Block in the Prevention of Postoperative Pain in Shoulder Surgery
Dear Patient, You have been scheduled for shoulder surgery by your surgeon. This surgery is performed under general anesthesia, that is, by putting the patient to sleep, and then moderate or severe pain is experienced. In order to prevent this post-operative pain, painkillers are given through the vascular access or the operated area, namely the shoulder, is locally anesthetized. Many techniques are used to numb the shoulder locally. One of these techniques is the pericapsular nerve group block and it is a newly defined technique.
In this block, some of the nerves that carry the pain sensation of the shoulder are temporarily anesthetized with local anesthetics.
This study will investigate how effective this block is in reducing pain associated with shoulder surgery.
Read the detailed description
Dear Patient, You have been scheduled for shoulder surgery by your surgeon. This surgery is performed under general anesthesia, that is, by putting the patient to sleep, and then moderate or severe pain is experienced. In order to prevent this pain to be experienced, analgesics are given through the vascular access or the operated area, namely the shoulder, is locally anesthetized. Different techniques are used to numb the shoulder locally. One of these techniques is pericapsular nerve group block. In this block, some of the nerves that carry the pain sensation of the shoulder are temporarily anesthetized with local anesthetics. Thus, it is aimed to reduce post-operative pain.
In this study, we plan to investigate how effective the pericapsular nerve group block is on postoperative pain. In this scientific study, patients will be randomly divided into two groups. Pericapsular nerve group block will be applied to one group of patients, while the other group will not be blocked. Pain medication will be administered intravenously to both groups before waking them up, and at the same time, a device called 'Patient Controlled Analgesia' (PCA) containing a very strong pain medication will be inserted in all patients in the service.
This device; It is a device that contains analgesics and gives analgesics to the patient through the vascular access according to the patient's request, and it works with the help of a button on it. When the patient feels pain, he will press the button and the device will give the medicine to the patient in a predetermined dose and time. The device records the total amount of pain medication sent in 24 hours on its screen. The amount of medication delivered by this device will be compared between patients with and without block. Thus, the effect of pericapsular nerve group block on postoperative pain will be investigated.
What are the procedures to be applied in the research? The surgery that will be applied to you is performed under general anesthesia. Pericapsular nerve group block, which is one of the pain relief methods we apply for shoulder surgery; It involves administering a local anesthetic drug with the help of a needle between the muscles in the shoulder and numbing your shoulder area.
After the blocking procedure, painful stimulus will be given and it will be checked whether you have pain and loss of sensation and what it is worth. If there is loss of feeling, the block will be considered successful.
After the evaluation of the block procedure is completed, you will be given general anesthesia, that is, you will be put to sleep. At the end of the surgery and at the 4th, 8th, 12th and 24th hours after the surgery, the severity of your pain will be evaluated and the total amount of analgesic consumed will be recorded. A scale that includes scoring pain between 0 and 10, called "NRS (numerical rating scale)" will be used. With this scale, you will be asked to give a score between 0 and 10 according to the severity of the pain. 0 points; "no pain", 5 points; moderate pain, and 10 points means "the most severe pain the patient has ever felt".
- Conditions
- Postoperative Pain
- Being tested
- Pericapsular nerve group block
- Keywords
- pericapsular nerve group block, postoperative pain, shoulder surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group blockProcedure or surgery
The patient's arm is externally rotated and abducted at 45 degrees. A longitudinal linear ultrasound probe is placed between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle on it, a 50 mm needle is inserted with the "in-plane" technique. When the needle passes through the deltoid muscle and touches the subscapularis tendon, a hard bone-like tissue is felt and the needle is not advanced any further. It is noteworthy that the subscapularis tendon is very rigid and resistant to needle penetration when performing the pericapsular nerve group block. The needle tip is placed between the deltoid muscle and the subscapularis tendon and a local anesthetic drug (20 ml, %0.5 bupivacain hydrochlorur) is injected
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular nerve group block (Group P) | Experimental | Pericapsular nerve group block will be performed with 20 ml of 0.5% bupivacaine hydrochloride before general anesthesia is applied to the patients in Group P. Receives: Procedure: Pericapsular nerve group block |
| control group (Group C) | No intervention | No block will be applied to patients in Group C. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of pericapsular nerve group block on postoperative pain.
Postoperative pain will be assessed using the NRS score (Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain) at 0, 4, 8, 12, and 24 hours.
Measured: 24 hours
Secondary outcomes (1)
Postoperative pain assessment is to evaluate time to first analgesia requirement, total amount of analgesic consumed, and complications.
Demanded/administered analgesic ratio in PCA (patient control analgesia) device
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMİNE ASLANLAR, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940454
- Sponsor's protocol ID
- PENG
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.
PubMed 34118263Ramadurai R, Bhoi D, Nagarajappa A, Amar P. Pericapsular nerve group block (PENG) at neutral position for shoulder manipulation: A feasible approach for a new indication. J Clin Anesth. 2021 Dec;75:110541. doi: 10.1016/j.jclinane.2021.110541. Epub 2021 Oct 12. No abstract available.
PubMed 34653775
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pericapsular Nerve Group Block in the Prevention of Postoperative Pain in Shoulder Surgery
- ClinicalTrials.gov ID
- NCT05940454
- Acronym / sponsor ID
- PENG
- Conditions
- Postoperative Pain
- Keywords
- pericapsular nerve group block, postoperative pain, shoulder surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 11 Jul 2023 (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.
Dear Patient, You have been scheduled for shoulder surgery by your surgeon. This surgery is performed under general anesthesia, that is, by putting the patient to sleep, and then moderate or severe pain is experienced. In order to prevent this post-operative pain, painkillers are given through the vascular access or the operated area, namely the shoulder, is locally anesthetized. Many techniques are used to numb the shoulder locally. One of these techniques is the pericapsular nerve group block and it is a newly defined technique.
In this block, some of the nerves that carry the pain sensation of the shoulder are temporarily anesthetized with local anesthetics.
This study will investigate how effective this block is in reducing pain associated with shoulder surgery.
Detailed description
Dear Patient, You have been scheduled for shoulder surgery by your surgeon. This surgery is performed under general anesthesia, that is, by putting the patient to sleep, and then moderate or severe pain is experienced. In order to prevent this pain to be experienced, analgesics are given through the vascular access or the operated area, namely the shoulder, is locally anesthetized. Different techniques are used to numb the shoulder locally. One of these techniques is pericapsular nerve group block. In this block, some of the nerves that carry the pain sensation of the shoulder are temporarily anesthetized with local anesthetics. Thus, it is aimed to reduce post-operative pain.
In this study, we plan to investigate how effective the pericapsular nerve group block is on postoperative pain. In this scientific study, patients will be randomly divided into two groups. Pericapsular nerve group block will be applied to one group of patients, while the other group will not be blocked. Pain medication will be administered intravenously to both groups before waking them up, and at the same time, a device called 'Patient Controlled Analgesia' (PCA) containing a very strong pain medication will be inserted in all patients in the service.
This device; It is a device that contains analgesics and gives analgesics to the patient through the vascular access according to the patient's request, and it works with the help of a button on it. When the patient feels pain, he will press the button and the device will give the medicine to the patient in a predetermined dose and time. The device records the total amount of pain medication sent in 24 hours on its screen. The amount of medication delivered by this device will be compared between patients with and without block. Thus, the effect of pericapsular nerve group block on postoperative pain will be investigated.
What are the procedures to be applied in the research? The surgery that will be applied to you is performed under general anesthesia. Pericapsular nerve group block, which is one of the pain relief methods we apply for shoulder surgery; It involves administering a local anesthetic drug with the help of a needle between the muscles in the shoulder and numbing your shoulder area.
After the blocking procedure, painful stimulus will be given and it will be checked whether you have pain and loss of sensation and what it is worth. If there is loss of feeling, the block will be considered successful.
After the evaluation of the block procedure is completed, you will be given general anesthesia, that is, you will be put to sleep. At the end of the surgery and at the 4th, 8th, 12th and 24th hours after the surgery, the severity of your pain will be evaluated and the total amount of analgesic consumed will be recorded. A scale that includes scoring pain between 0 and 10, called "NRS (numerical rating scale)" will be used. With this scale, you will be asked to give a score between 0 and 10 according to the severity of the pain. 0 points; "no pain", 5 points; moderate pain, and 10 points means "the most severe pain the patient has ever felt".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular nerve group block (Group P) | Experimental | Procedure: Pericapsular nerve group blockPericapsular nerve group block will be performed with 20 ml of 0.5% bupivacaine hydrochloride before general anesthesia is applied to the patients in Group P. |
| control group (Group C) | No intervention | –No block will be applied to patients in Group C. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- coagulopathy,
- neuropathy,
- use of anticoagulants,
- severe diabetes mellitus,
- local anesthetic and/or opioid allergy or sensitivity,
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 |
|---|---|---|
| Pericapsular nerve group blockThe patient's arm is externally rotated and abducted at 45 degrees. A longitudinal linear ultrasound probe is placed between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle on it, a 50 mm needle is inserted with the "in-plane" technique. When the needle passes through the deltoid muscle and touches the subscapularis tendon, a hard bone-like tissue is felt and the needle is not advanced any further. It is noteworthy that the subscapularis tendon is very rigid and resistant to needle penetration when performing the pericapsular nerve group block. The needle tip is placed between the deltoid muscle and the subscapularis tendon and a local anesthetic drug (20 ml, %0.5 bupivacain hydrochlorur) is injected | Procedure or surgery | Pericapsular nerve group block (Group P) |
Primary outcome
To investigate the effect of pericapsular nerve group block on postoperative pain.
Time frame: 24 hours
Postoperative pain will be assessed using the NRS score (Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain) at 0, 4, 8, 12, and 24 hours.
1 secondary outcome
Postoperative pain assessment is to evaluate time to first analgesia requirement, total amount of analgesic consumed, and complications.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 34118263Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.
- Background: PubMed 34653775Ramadurai R, Bhoi D, Nagarajappa A, Amar P. Pericapsular nerve group block (PENG) at neutral position for shoulder manipulation: A feasible approach for a new indication. J Clin Anesth. 2021 Dec;75:110541. doi: 10.1016/j.jclinane.2021.110541. Epub 2021 Oct 12. No abstract available.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group block in people with Postoperative Pain, run by Selcuk University.
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 0 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
To investigate the effect of pericapsular nerve group block on postoperative pain. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05940454, which also lists 2 linked publications.
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 11 Jul 2023.