CClinicalTrials.gg
RecruitingNCT05921110PENGUpdated Jun 27, 2023

Evaluation of the Effectiviness of Two Different Bupivacaine Concentrations of the Pericapsular Nerve Group (PENG) Block

An interventional study of Pericapsular nerve group block 0,25% and Pericapsular nerve group block 0,16% in Hip Fractures and Postoperative Pain, sponsored by Ilker Ital. Recruiting at 2 sites in Turkey. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-06-27.

Sponsored by Ilker Ital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The use of regional anaesthesia techniques as part of multimodal analgesia in hip surgeries improves postoperative analgesia. PENG (Pericapsular nerve group) block is an effective motor sparing analgesia technique used in hip surgeries. The purpose of this study was to assess the efficacy of PENG block in terms of analgesic requirements and pain density in patients undergoing hip surgery, using two different concentrations of local anaesthetic.

Read the detailed description

Hip operations; it is applied in femur fractures adjacent to the hip joint or in pathologies requiring reconstruction. It is operated with general anesthesia or neuraxial anesthetic blocking methods. Patients who are planned to heal bone and regain function with prosthesis after these operations are faced with acute pain due to surgical incisions and traumas in the postoperative period.

Pharmacological treatment comes to the fore in pain management in patients who are admitted to the service after surgery. Today, multimodal pain treatment is recommended for postoperative analgesia, and regional analgesia is a very important part of this. Despite their side effects, opioids are frequently used in patients with postoperative pain. In patients who will undergo hip surgery, apart from pharmacological methods; methods such as neuraxial blocks (spinal anesthesia, epidural anesthesia) are used. Alternatively, peripheral nerve blocks such as femoral nerve, sciatic nerve, lumbar plexus block, 3 in 1 block acting on this area are applied. With the increase in the use of ultrasound (US), the number and success of analgesic and anesthetic nerve blocks have increased. Especially US guided field blocks (such as erector spinae block, suprainguinal fascia iliaca block, pericapsular nerve group (PENG) block...) have become an important part of multimodal analgesia. As the advantages of these blocks made with US; technique is simple, its application is practical and it is safe in terms of complications. PENG block applied with US is one of the new methods; local anesthetic drugs are injected into the fascia, which is the transition region of the articular branches that receive the sensation of the hip joint.

The aim of this study is to evaluate the analgesia levels of patients undergoing hip surgery by applying two different doses of PENG block after surgery. Sixtysix patients with ASA I-III risk, aged between 18-85 years, who were planned for elective hip surgery under spinal anesthesia at Bolu AIBU Medical Faculty Hospital will be included in the study. The patients will be randomly divided into 3 groups (Group 0.25, Group 0.16, Group C (Control)) randomized, prospective, using the randomizer.org website. Patients will be informed about the study during the preoperative evaluation and information will be given about the visual analog pain scale (VAS) and Patient controlled analgesia (PCA) device to be used for postoperative analgesia. Both verbal and written consent will be obtained. After being taken to the operating table, standard monitoring will be performed by opening a vascular access to all patients. Anesthesia will be provided by spinal anesthesia from neuraxial blocks. A total of 12.5-15 mg with a 25-27 G spinal needle from the L3-4 vertebral space to the patient. (2.5-3 ml. volume) Heavy Bupivacaine 0.5% will be injected into the subarachnoid area and the success of the block will be checked and the surgical procedure will be started. Ultrasound-guided PENG block will be applied to patients with postoperative PENG block at doses of 2,5 mg/ml and 1,6mg/ml in 20 ml volumes on the side of the operated hip, depending on their groups. In the control group, only standard analgesic procedures will be applied. In the patients to be treated, asepsis-antisepsis will be applied in the supine position and the anterior inferior iliac process and iliopubic eminence, tendon of the iliopsoas muscle will be visualized using the convex ultrasound probe (Esaote MyLab 5). After the hydrodissection is made with 2 ml of physiological saline, it will be seen that there is no air or blood with the help aspiration. Local anesthetic solution will be applied and its distribution will be monitored. No postoperative block procedure will be applied to the patients in Group C.

Postoperative intravenous (iv) PCA will be applied to patients in all three groups. For this, Tramadol HCL (Tramosel 100 mg/2 ml Haver Pharma İlaç A.Ş, Istanbul) continuous opioid infusion at 4mg/ml concentration is 2 ml/hour, at a maximum dose of 400mg within 24 hours, with a 20-minute locking interval and bolus doses of 20 mg tramadol HCL will be administered iv each time the patient presses button. Paracetamol 3x1000 mg iv will be applied. Before the operation, the patient will be told to press the button whenever he has pain. VAS values at the 1st, 2nd, 4th, 8th, 12th, 18th, 24th hours after the operation, SAP (Systolic arterial pressure), DAP (Distolic arterial pressure), MAP (Mean arterial pressure), HR (Heart pulse rate), SpO2 (Peripheral oxygen saturation), opioid consumption (tramadol HCL ) at the 0-1, 1-12, 12-24 hours, and patient satisfaction level before discharge, whether there is motor loss or not will be registered. If nausea, vomiting, pruritus, allergy, desaturation, and other side effects occur in the patient follow-up, they will be recorded. Nausea, vomiting will be treated with ondansetron iv, rash and pruritus will be treated with feniramin hidrojen maleat iv. When analgesia is insufficient, 75 mg diclofenac sodium intramuscular (im) as a rescue analgesic when VAS is above 4 was planned.

02

Conditions studied

  • Hip Fractures
  • Postoperative Pain

Keywords

  • PENG Block
  • Hip Surgery
  • Postoperative Pain
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 66 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

This is the only study on the registry with Ilker Ital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA I- III risk undergoing hip surgery.

Exclusion criteria

Exclusion Criteria:

  • Contraindications for regional blocks (eg. patient refusal, coagulopathy, infection at the injection site), allergic reaction to local anesthetics and other analgesics.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Active comparator
    PENG Block %0,25

    PENG Block will be applied with 0.25% bupivacaine in 20 ml volume under ultrasound guidance.

    Procedure: Pericapsular nerve group block 0,25%

  • Active comparator
    PENG Block %0,16

    PENG Block will be applied with 0.16% bupivacaine in 20 ml volume under ultrasound guidance.

    Procedure: Pericapsular nerve group block 0,16%

  • No intervention
    Control Group

    Control

Interventions

  • ProcedurePericapsular nerve group block 0,25%

    Used for postoperative anagesia after hip operations under spinal anaesthesia. Drug: Bupivacaine (Block Drug) For block performances, 0,25% Bupivacaine will be used at 20 ml volume.

    Also known as: PENG Block

  • ProcedurePericapsular nerve group block 0,16%

    Used for postoperative anagesia after hip operations under spinal anaesthesia. Drug: Bupivacaine (Block Drug) For block performances, 0,16% Bupivacaine will be used at 20 ml volume

    Also known as: PENG Block

06

What researchers measure

Primary outcomes

  1. Analgesic requirement

    The amount of analgesic required in the first postoperative 24 hours is the primary outcome of this study.

    Time frame: First 24 Hour

Secondary outcomes

  1. VAS ( Visual Analogue Scale) scores

    The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

    Time frame: 1th, 2nd, 4th, 8th,12th,18th and 24th hours

07

Study locations

2 of 2 sites recruiting
  • Bolu Abant İzzet Baysal Medical School
    Bolu, 14030, Turkey
    Recruiting
  • Bolu Abant İzzet Baysal University Faculty of Medicine
    Bolu, 14030, Turkey
    • Ilker Ital, MD · Contact · ilkerital@gmail.com · 05337723300
    • Hamit Yoldas, MD · Sub investigator
    • Cengiz Isık, MD · Sub investigator
    • Fatma Saridemir, MD · Principal investigator
    • Ilker Ital, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Remily EA, Hochstein SR, Wilkie WA, Mohamed NS, Thompson JV, Kluk MW, Nace J, Delanois RE. The pericapsular nerve group block: a step towards outpatient total hip arthroplasty? Hip Int. 2022 May;32(3):318-325. doi: 10.1177/1120700020978211. Epub 2020 Dec 3. PubMed 33269617 ↗
  • Guven Kose S, Kose HC, Arslan G, Eler Cevik B, Tulgar S. Evaluation of ultrasound-guided adductor canal block with two different concentration of bupivacaine in arthroscopic knee surgery: A feasibility study. Int J Clin Pract. 2021 Nov;75(11):e14747. doi: 10.1111/ijcp.14747. Epub 2021 Sep 3. PubMed 34428334 ↗
  • Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12. PubMed 33432791 ↗
  • Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. PubMed 30063657 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05921110
Lead sponsor
Ilker Ital
Collaborators
Abant Izzet Baysal University
Responsible party
Ilker Ital (Assistan Professor Doctor, Abant Izzet Baysal University) — Sponsor-investigator
First posted
Jun 27, 2023
Start date
May 15, 2023
Primary completion
Nov 30, 2023 (estimated)
Completion
Nov 30, 2023 (estimated)
Last update
Jun 27, 2023

Study contacts

Ilker Ital
Contact
ilkerital@gmail.com
+905337723300
Fatma Saridemir
Contact
fatos_dtz2@hotmail.com
+905067179398
Fatma Saridemir
principal investigator · Bolu Abant İzzet Baysal Medical School
Hamit Yoldas
study director · Bolu Abant İzzet Baysal Medical School
Ilker Ital
study chair · Bolu Abant İzzet Baysal Medical School
Cengiz Isık
study chair · Bolu Abant İzzet Baysal Medical School

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion