Regional AnesthesiaNCT06166602
US-guided Pericapsular Nerve Group (PENG) Block in Different Volumes on Postoperative Pain in Hip Replacement Surgeries
A study testing PENG block with 0.25% bupivacaine. in people with Regional Anesthesia and Postoperative Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain management has an important place in anesthesia practices. In order to ensure patient comfort after the surgery, to start postoperative rehabilitation early, and to prevent the process from causing mood disorders such as anxiety and pathological conditions such as chronic pain syndrome, the pain… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia, Postoperative Pain, Hip Surgery
- What is being tested?
- PENG block with 0.25% bupivacaine.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2023to 22 Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with informed consent
- Patients planned for hip surgery
- Those between the ages of 18-80
- ASA (American Society of Anesthesiologists) I-III patients
Who cannot join
- Patients who do not give consent
- Patients with coagulopathy
- Patients with a history of local anesthetic drug allergy and toxicity
- Patients with advanced organ failure
- Patients with mental retardation
- Patients with infection at the injection site
- Pediatric patients and patients over 80 years of age
- Pregnant patients will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Impacts of Ultrasound-guided Pericapsular Nerve Group (PENG) Block Applied in Different Volumes on Postoperative Pain in Hip Replacement Surgeries: A Randomized Clinical Trial
Postoperative pain management has an important place in anesthesia practices. In order to ensure patient comfort after the surgery, to start postoperative rehabilitation early, and to prevent the process from causing mood disorders such as anxiety and pathological conditions such as chronic pain syndrome, the pain caused by the operation in the postoperative period must be effectively relieved. Pericapsular nerve group (PENG) block; It is a regional anesthesia technique that targets the anterior capsule of the hip joint and aims to block the joint branches of the accessory obturator nerve and femoral nerve by administering local anesthetic. Although it has been described recently, controlled prospective studies in the literature have shown it to be a safe and effective regional technique for postoperative pain after hip surgery. However, volume studies on this block are limited.
Therefore, in this study, we aimed to determine the optimal dose by comparing the effectiveness of PENG block on pain using different local anesthetic volumes.
Read the detailed description
Postoperative pain management has an important place in anesthesia practices. In order to ensure patient comfort after the surgery, to start postoperative rehabilitation early, and to prevent the process from causing mood disorders such as anxiety and pathological conditions such as chronic pain syndrome, the pain caused by the operation in the postoperative period must be effectively relieved. Pericapsular nerve group (PENG) block; It is a regional anesthesia technique that targets the anterior capsule of the hip joint and aims to block the joint branches of the accessory obturator nerve and femoral nerve by administering local anesthetic. Although it has been described recently, controlled prospective studies in the literature have shown it to be a safe and effective regional technique for postoperative pain after hip surgery. However, volume studies on this block are limited.
Therefore, in this study, we aimed to determine the optimal dose by comparing the effectiveness of PENG block on pain using different local anesthetic volumes
It was planned to be performed with patients who had hip replacement surgery and patients who are included in the study after obtaining the necessary consents will be randomly assigned to one of Group I or Group II by sealed envelope method. Patients taken to the operating room will receive standard monitoring such as ECG, peripheral oxygen saturation and noninvasive blood pressure monitoring. Midazolam 1 mg IV, fentanyl 1 mcg/kg IV, propofol 1.5-2 mg/kg IV and rocuronium 0.6 mg/kg IV. After routine anesthesia induction, the patient will be intubated with the appropriate intubation tube. Anesthesia maintenance will be provided with 0.8 MAC sevoflurane and remifentanil infusion, as we apply in our routine. Ventilator parameters will be regulated as FiO2 50%, Vt: 0.8 ml/kg, and respiratory frequency 10-14/min, so that EtCO2 is in the range of 25-40 mmHg. Near the end of the operation, our routine analgesic application is 0.1mg/kg IV Morphine will be administered. After the operation is completed, the pericapsular nerve group block will be performed by entering the patient's suprainguinal area with a 100 mm block needle under ultrasound guidance, as in the standard practice of our clinic, and local anesthetic will be administered to the area between the psoas muscle tendon and the hip joint. During the procedure, ultrasound will be used to determine the location and visualize the distribution of the administered drug. The administered drug volume was planned to be 20 cc of 0.25% bupivacaine for group I patients and 10cc of 0.25% bupivacaine for group II patients (their concentrations would be the same but their volumes would be different). Then, the patient will be awakened from anesthesia; Patients with adequate respiratory effort below sevoflurane 0.2 MAC should receive atropine 0.1 mg/kg and neostigmine 0.05 mg/kg IV, which we routinely use, will be applied and extubated. Postoperative 30th minute, 4th hour, 6th hour, 12th hour, 24th hour pain intensities of the patients were evaluated using NRS (Numerical rating Scale) score (0-10) and postoperative Nausea and Vomiting Descriptive Scale (0 = none, 1 = mild nausea, 2 = nausea, 3 = vomiting once, 4 = vomiting more than once) will be evaluated and recorded. At the end of the surgery, patients will be given IV Morphine PCA (patient controlled analgesia) with a 2 ml bolus at a concentration of 0.5 mg/cc for 15 minutes and the amount of Morphine used during the hours when the patient's NRS score is recorded will be recorded. The patients' mobilization time after the operation will be recorded. 0.15 mg/kg IV Ondansetron will be administered for patients with Postoperative Nausea and Vomiting Descriptive Scale 2 and above. 24 hours after the surgery, patient satisfaction will be evaluated and recorded on a Likert Satisfaction scale (1-5).
- Conditions
- Regional Anesthesia, Postoperative Pain, Hip Surgery
- Being tested
- PENG block with 0.25% bupivacaine.
- Keywords
- Regional Anesthesia
- 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 with 0.25% bupivacaine.Drug
Also called Marcain®
Peng block will be applied to the same side as the surgery, using 0.25% bupivacaine at the same concentration in different volumes.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | PENG block was planned to be applied to group 1 patients with 20 cc of 0.25% bupivacaine. Receives: Drug: PENG block with 0.25% bupivacaine. |
| Group 2 | Active comparator | PENG block was planned to be applied to group 2 patients with 10 cc of 0.25% bupivacaine. Receives: Drug: PENG block with 0.25% bupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale Score
Numeric Rating Scale Score (0: No pain, 10: Worst pain imaginable)
Measured: Up to 24 hours
Secondary outcomes (3)
Postoperative Opioid Consumption
24 hour morphine consumption on PCA device
Measured: Up to 24 hours
Postoperative Nausea and Vomiting
Postoperative Nausea and Vomiting Scale (0: no PONV, 1: mild nausea, 2: severe nausea, 3: vomiting once in 24 hours, 4: Vomiting more than once in 24 hours)
Measured: Up to 24 hours
Patient satisfaction
Likert scale (1-5, 1: very unsatisfied, 2: unsatisfied, 3: neutral, 4: satisfied, 5: very satisfied)
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start30 Jul 2023
- Primary completion20 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokce Alis, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166602
- Sponsor's protocol ID
- 2023/0455
- Status last verified
- May 2026
- First submitted
- 4 Dec 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
PubMed 34196965Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408.
PubMed 35330408Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.
PubMed 35933328Alis G, Ozden MGN, Karaoglu RO. Pericapsular nerve group (PENG) block at 10 mL vs. 20 mL for postoperative analgesia after total hip arthroplasty: a randomized controlled trial. BMC Anesthesiol. 2026 May 18;26(1):416. doi: 10.1186/s12871-026-03923-8.
PubMed 42151839
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Impacts of Ultrasound-guided Pericapsular Nerve Group (PENG) Block Applied in Different Volumes on Postoperative Pain in Hip Replacement Surgeries: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06166602
- Acronym / sponsor ID
- 2023/0455
- Conditions
- Regional Anesthesia, Postoperative Pain, Hip Surgery
- Keywords
- Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 12 Dec 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.
Postoperative pain management has an important place in anesthesia practices. In order to ensure patient comfort after the surgery, to start postoperative rehabilitation early, and to prevent the process from causing mood disorders such as anxiety and pathological conditions such as chronic pain syndrome, the pain caused by the operation in the postoperative period must be effectively relieved. Pericapsular nerve group (PENG) block; It is a regional anesthesia technique that targets the anterior capsule of the hip joint and aims to block the joint branches of the accessory obturator nerve and femoral nerve by administering local anesthetic. Although it has been described recently, controlled prospective studies in the literature have shown it to be a safe and effective regional technique for postoperative pain after hip surgery. However, volume studies on this block are limited.
Therefore, in this study, we aimed to determine the optimal dose by comparing the effectiveness of PENG block on pain using different local anesthetic volumes.
Detailed description
Postoperative pain management has an important place in anesthesia practices. In order to ensure patient comfort after the surgery, to start postoperative rehabilitation early, and to prevent the process from causing mood disorders such as anxiety and pathological conditions such as chronic pain syndrome, the pain caused by the operation in the postoperative period must be effectively relieved. Pericapsular nerve group (PENG) block; It is a regional anesthesia technique that targets the anterior capsule of the hip joint and aims to block the joint branches of the accessory obturator nerve and femoral nerve by administering local anesthetic. Although it has been described recently, controlled prospective studies in the literature have shown it to be a safe and effective regional technique for postoperative pain after hip surgery. However, volume studies on this block are limited.
Therefore, in this study, we aimed to determine the optimal dose by comparing the effectiveness of PENG block on pain using different local anesthetic volumes
It was planned to be performed with patients who had hip replacement surgery and patients who are included in the study after obtaining the necessary consents will be randomly assigned to one of Group I or Group II by sealed envelope method. Patients taken to the operating room will receive standard monitoring such as ECG, peripheral oxygen saturation and noninvasive blood pressure monitoring. Midazolam 1 mg IV, fentanyl 1 mcg/kg IV, propofol 1.5-2 mg/kg IV and rocuronium 0.6 mg/kg IV. After routine anesthesia induction, the patient will be intubated with the appropriate intubation tube. Anesthesia maintenance will be provided with 0.8 MAC sevoflurane and remifentanil infusion, as we apply in our routine. Ventilator parameters will be regulated as FiO2 50%, Vt: 0.8 ml/kg, and respiratory frequency 10-14/min, so that EtCO2 is in the range of 25-40 mmHg. Near the end of the operation, our routine analgesic application is 0.1mg/kg IV Morphine will be administered. After the operation is completed, the pericapsular nerve group block will be performed by entering the patient's suprainguinal area with a 100 mm block needle under ultrasound guidance, as in the standard practice of our clinic, and local anesthetic will be administered to the area between the psoas muscle tendon and the hip joint. During the procedure, ultrasound will be used to determine the location and visualize the distribution of the administered drug. The administered drug volume was planned to be 20 cc of 0.25% bupivacaine for group I patients and 10cc of 0.25% bupivacaine for group II patients (their concentrations would be the same but their volumes would be different). Then, the patient will be awakened from anesthesia; Patients with adequate respiratory effort below sevoflurane 0.2 MAC should receive atropine 0.1 mg/kg and neostigmine 0.05 mg/kg IV, which we routinely use, will be applied and extubated. Postoperative 30th minute, 4th hour, 6th hour, 12th hour, 24th hour pain intensities of the patients were evaluated using NRS (Numerical rating Scale) score (0-10) and postoperative Nausea and Vomiting Descriptive Scale (0 = none, 1 = mild nausea, 2 = nausea, 3 = vomiting once, 4 = vomiting more than once) will be evaluated and recorded. At the end of the surgery, patients will be given IV Morphine PCA (patient controlled analgesia) with a 2 ml bolus at a concentration of 0.5 mg/cc for 15 minutes and the amount of Morphine used during the hours when the patient's NRS score is recorded will be recorded. The patients' mobilization time after the operation will be recorded. 0.15 mg/kg IV Ondansetron will be administered for patients with Postoperative Nausea and Vomiting Descriptive Scale 2 and above. 24 hours after the surgery, patient satisfaction will be evaluated and recorded on a Likert Satisfaction scale (1-5).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: PENG block with 0.25% bupivacaine.PENG block was planned to be applied to group 1 patients with 20 cc of 0.25% bupivacaine. |
| Group 2 | Active comparator | Drug: PENG block with 0.25% bupivacaine.PENG block was planned to be applied to group 2 patients with 10 cc of 0.25% bupivacaine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with informed consent
- Patients planned for hip surgery
- Those between the ages of 18-80
- ASA (American Society of Anesthesiologists) I-III patients
Key exclusion criteria (8 listed)
- Patients who do not give consent
- Patients with coagulopathy
- Patients with a history of local anesthetic drug allergy and toxicity
- Patients with advanced organ failure
- Patients with mental retardation
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 with 0.25% bupivacaine.Also: Marcain®Peng block will be applied to the same side as the surgery, using 0.25% bupivacaine at the same concentration in different volumes. | Drug | Group 1, Group 2 |
Primary outcome
Numeric Rating Scale Score
Time frame: Up to 24 hours
Numeric Rating Scale Score (0: No pain, 10: Worst pain imaginable)
3 secondary outcomes
Postoperative Opioid Consumption
Time frame: Up to 24 hours
Postoperative Nausea and Vomiting
Time frame: Up to 24 hours
Patient satisfaction
Time frame: Up to 24 hours
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 11 May 2026.
- Background: PubMed 34196965Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
- Background: PubMed 35330408Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408.
- Background: PubMed 35933328Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.
- Derived from this study: PubMed 42151839Alis G, Ozden MGN, Karaoglu RO. Pericapsular nerve group (PENG) block at 10 mL vs. 20 mL for postoperative analgesia after total hip arthroplasty: a randomized controlled trial. BMC Anesthesiol. 2026 May 18;26(1):416. doi: 10.1186/s12871-026-03923-8.
- 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 PENG block with 0.25% bupivacaine. in people with Regional Anesthesia and Postoperative Pain, run by Istanbul Medeniyet 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 8 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 11 May 2026. 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?
Numeric Rating Scale Score (time frame: Up to 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 NCT06166602, which also lists 4 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 May 2026.