Postoperative PainNCT04738500
Postoperative Analgesic Efficacy of Pericapsular Nerve Group Block (PENG) Block for Knee Arthroscopy
A study testing PENG Block combinated with PCA and PCA in people with Postoperative Pain, run by Bora Bilal at 1 site in Turkey (Türkiye).
Trial summary
Pericapsular nerve group block (PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- PENG Block combinated with PCA and PCA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 15 Jun 2021
- 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 agreed to receive PENG block
- Knee arthroscopy
Who cannot join
- Other kinds of knee surgery
- Patients refuse to receive PENG block
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
KSU Faculty of Medicine Research Hospital
Kahramanmaraş, 46200
Bora Bilal, 03443003245, bbilal@ksu.edu.tr
About this study
Pericapsular nerve group block (PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee arthroscopy.
Read the detailed description
Pericapsular nerve group block(PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee artroscopy. Blockade of the branches of the femoral and obturator nerves that provide innervation to any structures distal enough to be useful in knee.
- Conditions
- Postoperative Pain
- Being tested
- PENG Block combinated with PCA, PCA
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG Block combinated with PCAProcedure or surgery
Also called PCA
After spinal anesthesia PENG block will be performed
PCAProcedure or surgery
PCA will be applied after surgery
| Study group | Role | What they receive |
|---|---|---|
| PENG Block | Active comparator | PENG Block combinate with PCA Receives: Procedure: PENG Block combinated with PCA |
| CONTROL | Sham comparator | PCA Receives: Procedure: PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
First analgesic demand
The time interval from PENG blocks to the first analgesic demand.
Measured: 24 Hours
Secondary outcomes (2)
Opioid consumption
Total opioid analgesic consumption
Measured: 24 Hours
Numeric Rating Scale
The maximum score on a 10cm numeric rating scale: (0 to 10cm) (0 = no pain, 10 = worst imaginable pain)
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 posted4 Feb 2021
- Study start15 Apr 2021 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bora Bilal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bora Bilal, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738500
- Sponsor's protocol ID
- 123
- Status last verified
- Apr 2021
- First submitted
- 1 Feb 2021
- Last updated
- 14 Apr 2021
- 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 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Pericapsular Nerve Group Block (PENG) Block for Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT04738500
- Acronym / sponsor ID
- 123
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bora BilalUniversity, hospital or other
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 4 Feb 2021 (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.
Pericapsular nerve group block (PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee arthroscopy.
Detailed description
Pericapsular nerve group block(PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee artroscopy. Blockade of the branches of the femoral and obturator nerves that provide innervation to any structures distal enough to be useful in knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG Block | Active comparator | Procedure: PENG Block combinated with PCAPENG Block combinate with PCA |
| CONTROL | Sham comparator | Procedure: PCAPCA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients agreed to receive PENG block
- Knee arthroscopy
Key exclusion criteria (2 listed)
- Other kinds of knee surgery
- Patients refuse to receive PENG block
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 |
|---|---|---|
| PENG Block combinated with PCAAlso: PCAAfter spinal anesthesia PENG block will be performed | Procedure or surgery | PENG Block |
| PCAPCA will be applied after surgery | Procedure or surgery | CONTROL |
Primary outcome
First analgesic demand
Time frame: 24 Hours
The time interval from PENG blocks to the first analgesic demand.
2 secondary outcomes
Opioid consumption
Time frame: 24 Hours
Numeric Rating Scale
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 14 Apr 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG Block combinated with PCA and PCA in people with Postoperative Pain, run by Bora Bilal 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 2 inclusion and 2 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 14 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
Contact Bora Bilal, Assos. Prof. (05052354430, bilalbora@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First analgesic demand (time frame: 24 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 14 Apr 2021.