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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Istanbul Medeniyet University

    Istanbul

Other trials in Turkey (Türkiye)

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).

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 groups in NCT06166602
Study groupRoleWhat they receive
Group 1Active comparatorPENG 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 2Active comparatorPENG 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.

  1. Numeric Rating Scale Score

    Numeric Rating Scale Score (0: No pain, 10: Worst pain imaginable)

    Measured: Up to 24 hours

Secondary outcomes (3)
  1. Postoperative Opioid Consumption

    24 hour morphine consumption on PCA device

    Measured: Up to 24 hours

  2. 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

  3. 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.

  1. First posted12 Dec 2023
  2. Study start30 Jul 2023
  3. Primary completion20 Dec 2023
  4. Study completion22 Dec 2023

Resources

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)
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 34196965
  • Choi 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 35330408
  • Lin 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 35933328
  • Alis 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

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.

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