Opioid UsePARİAHNCT04698746
PENG vs Intra-articular Injection for Hip Arthroscopy
A study testing Pericapsular nerve group block and Intra-articular local anesthetic injection in people with Opioid Use and Acute Pain, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Hip arthroscopy is a popular surgical method that is increasingly being used for both intraarticular and extraarticular hip surgeries. Postoperative acute pain is difficult to control in hip surgeries due to the complex nature of hip innervation and the large number of surgical interventions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid Use, Acute Pain
- What is being tested?
- Pericapsular nerve group block and Intra-articular local anesthetic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2021to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Association of Anesthesiologists (ASA) physical status I - III
- BMI 20 to 35 kg / m2
- Patients scheduled for elective hip arthroscopy
- Able to provide informed consent.
Who cannot join
- Patients who refuse to participate in the study,
- Coagulopathy,
- Sepsis,
- Hepatic or renal insufficiency,
- Pregnancy
- Allergy to local anesthetic drugs,
Show all 17Show fewer
- Chronic pain condition requiring opioid intake at home,
- BMI above 40.
- History of psychiatric diseases needing treatment.
- Failure of nerve block
- Substance abuse history
- Hip revision surgery
- Underlying neurologic disorder affecting pain perception.
- Angina, heart attack, heart failure
- Kidney or hepatic insufficiency
- Stroke
- Gastrintestinal bleeding history
Trial locations and contacts
1 site in 1 country.
Yeşiltaş, Asist Prof. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakıf University
Istanbul, 34093
Serdar Yeşiltaş, Assist.Prof, 05423632630, syesiltas@bezmialem.edu.tr
About this study
Official title: Pericapsular Nerve Group (PENG) Block Versus Intra-articular Injection for Hip Arthroscopy: A Randomized Trial
Hip arthroscopy is a popular surgical method that is increasingly being used for both intraarticular and extraarticular hip surgeries. Postoperative acute pain is difficult to control in hip surgeries due to the complex nature of hip innervation and the large number of surgical interventions. Optimal treatment of postoperative pain in hip arthroscopy is very important to be able to perform rehabilitation, avoid opioid side effects and minimize unplanned re-hospitalization. Regional anesthesia techniques are widely used because of their proven efficacy in post-surgical pain management and their safety profile that ultimately contributes to early recovery. Many regional techniques such as neuraxial blocks, lumbar plexus block, femoral nerve block, fascia iliac block and intraarticular local anesthetic injection have been used for the treatment of acute postoperative pain.
Femoral nerve and fascia iliac blocks have shown good results for long-term post-surgery analgesia. However, the obturator nerve and accessory obturator nerve should be targeted to achieve more effective perioperative pain control. There are studies reporting that pericapsular nerve group block (PENG), which has been defined in recent years, provides effective perioperative analgesia in hip surgeries. In this study, we aim to compare the effectiveness of PENG block and intra-articular local anesthetic injection in hip arthroscopy.
- Conditions
- Opioid Use, Acute Pain
- Being tested
- Pericapsular nerve group block, Intra-articular local anesthetic injection
- Keywords
- Hip arthroscopy, intra-articular injection, PENG block
- Medical subject headings
- Acute Pain
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
PENG block will be made with 15 ml 0.5% bupivacaine + 2 mg dexamethasone + 14.5 ml NaCl under US-guidance
Intra-articular local anesthetic injectionProcedure or surgery
Intra-articular local anesthetic injection will be made with 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml NaCl
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided pericapsular nerve group block | Active comparator | Injection of 15 ml 0.5% bupivacaine + 2 mg dexamethasone + 14.5 ml isotonic saline mixture between iliopubic eminentia and psoas tendon under ultrasound guidance Receives: Procedure: Pericapsular nerve group block |
| Intra-articular local anesthetic injection | Active comparator | At the end of the surgical case, a total of 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml isotonic saline injection intra-articularly. Receives: Procedure: Intra-articular local anesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Measured: up to the first 24 hours postoperatively
Secondary outcomes (4)
Pain intensity score
Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be ) at 0.5, 1, 3, 6, 12, 24 hours postoperatively.
Measured: 0.5, 1, 3, 6, 12, 24 hours postoperatively.
First rescue analgesic time
The investigators will collect time to first rescue analgesic consumption in each group
Measured: up to the first 24 hours postoperatively
Postoperative nausea and vomiting
Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).
Measured: up to the first 24 hours postoperatively
Patient satisfaction
Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Measured: at the end of 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start20 Jan 2021
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Yeşiltaş, Bezmialem Vakif University
- Investigators
- Yeşiltaş, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698746
- Sponsor's protocol ID
- 71306642-050.05.04-
- Acronym
- PARİAH
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block Versus Intra-articular Injection for Hip Arthroscopy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04698746
- Acronym / sponsor ID
- PARİAH / 71306642-050.05.04-
- Conditions
- Opioid Use, Acute Pain
- Keywords
- Hip arthroscopy, intra-articular injection, PENG block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 7 Jan 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.
Hip arthroscopy is a popular surgical method that is increasingly being used for both intraarticular and extraarticular hip surgeries. Postoperative acute pain is difficult to control in hip surgeries due to the complex nature of hip innervation and the large number of surgical interventions. Optimal treatment of postoperative pain in hip arthroscopy is very important to be able to perform rehabilitation, avoid opioid side effects and minimize unplanned re-hospitalization. Regional anesthesia techniques are widely used because of their proven efficacy in post-surgical pain management and their safety profile that ultimately contributes to early recovery. Many regional techniques such as neuraxial blocks, lumbar plexus block, femoral nerve block, fascia iliac block and intraarticular local anesthetic injection have been used for the treatment of acute postoperative pain.
Femoral nerve and fascia iliac blocks have shown good results for long-term post-surgery analgesia. However, the obturator nerve and accessory obturator nerve should be targeted to achieve more effective perioperative pain control. There are studies reporting that pericapsular nerve group block (PENG), which has been defined in recent years, provides effective perioperative analgesia in hip surgeries. In this study, we aim to compare the effectiveness of PENG block and intra-articular local anesthetic injection in hip arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided pericapsular nerve group block | Active comparator | Procedure: Pericapsular nerve group blockInjection of 15 ml 0.5% bupivacaine + 2 mg dexamethasone + 14.5 ml isotonic saline mixture between iliopubic eminentia and psoas tendon under ultrasound guidance |
| Intra-articular local anesthetic injection | Active comparator | Procedure: Intra-articular local anesthetic injectionAt the end of the surgical case, a total of 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml isotonic saline injection intra-articularly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Association of Anesthesiologists (ASA) physical status I - III
- BMI 20 to 35 kg / m2
- Patients scheduled for elective hip arthroscopy
- Able to provide informed consent.
Key exclusion criteria (17 listed)
- Patients who refuse to participate in the study,
- Coagulopathy,
- Sepsis,
- Hepatic or renal insufficiency,
- Pregnancy
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 blockPENG block will be made with 15 ml 0.5% bupivacaine + 2 mg dexamethasone + 14.5 ml NaCl under US-guidance | Procedure or surgery | Ultrasound guided pericapsular nerve group block |
| Intra-articular local anesthetic injectionIntra-articular local anesthetic injection will be made with 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml NaCl | Procedure or surgery | Intra-articular local anesthetic injection |
Primary outcome
Postoperative opioid consumption
Time frame: up to the first 24 hours postoperatively
Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
4 secondary outcomes
Pain intensity score
Time frame: 0.5, 1, 3, 6, 12, 24 hours postoperatively.
First rescue analgesic time
Time frame: up to the first 24 hours postoperatively
Postoperative nausea and vomiting
Time frame: up to the first 24 hours postoperatively
Patient satisfaction
Time frame: at the end of 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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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.
Yeşiltaş, Asist Prof. contact
Yeşiltaş principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group block and Intra-articular local anesthetic injection in people with Opioid Use and Acute Pain, run by Bezmialem Vakif University 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 4 inclusion and 17 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 23 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serdar Yeşiltaş, Asist Prof. (05423632630, syesiltas@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: up to the first 24 hours postoperatively). 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 23 Jan 2024.