AzTrials
AzTrials

Postoperative PainPENGNCT06806865

Comparison of Continuous Fascia Iliaca Compartment Block With Continuous PENG Block in Total Hip Replacement Cases

A study testing Periarticular nerve group block (PENG) and Continuous supra-inguinal fascia iliaca compartment block (SIFICB) in people with Postoperative Pain and Regional Anesthesia, run by Namik Kemal 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

Adequate pain management after total hip arthroplasty (THA) is crucial for early ambulation and patient satisfaction. However, due to the hip joint's innervation complexity, the optimal regional analgesia technique for THA remains controversial. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Periarticular nerve group block (PENG) and Continuous supra-inguinal fascia iliaca compartment block (SIFICB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2023to 15 Dec 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients undergoing hip replacement for the first time
  • Patients aged 18-65 years, ASAI-II (American Society of Anesthesiology classification)
  • Patients without primary cancer and/or patients without metastatic bone fractures
  • Patients without allergy to local anaesthetics
  • Patients with an intellectual level that can use patient-controlled analgesia devices
  • Patients with a standard bleeding profile
  • Patients who gave written consent to participate in the study

Who cannot join

  • patients who have had a hip replacement and/or revision
  • patients who have primary cancer and/or fractures due to bone metastasis
  • patients who have a local anaesthetic allergy and/or a history of it
  • patients who are not intellectually competent enough to use a patient-controlled anesthesia device
  • patients who have undergone reoperation due to any surgical complication (bleeding, etc.) within 24 hours after surgery
  • patients who did not give written consent to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Namık Kemal Üniversitesi

    Tekirdağ, Süleymanpasa, 59030

Other trials in Turkey (Türkiye)

About this study

Adequate pain management after total hip arthroplasty (THA) is crucial for early ambulation and patient satisfaction. However, due to the hip joint's innervation complexity, the optimal regional analgesia technique for THA remains controversial.

Total hip arthroplasties are critical surgeries that can take steps to improve the quality of life and functional status of patients who do not respond to conservative treatments. However, patients may present with intense pain in the immediate postoperative period, resulting in inactivity, increased risk of complications, and greater opioid consumption, resulting in adverse effects and prolonged hospital stay. The challenging management of pain is explained by the complex innervation of the hip joint, in which the articular branches of the femoral, obturator, and accessory obturator nerves are responsible for the sensory innervation of the anterior capsule.

This randomized clinical trial compares the analgesic efficacy of FICB and PENG block following THA. Our preliminary results will be postoperative pain scores. As our anesthesia clinic, we routinely perform these known methods after surgery in these cases. Traditional intravenous analgesia methods cause many undesirable side effects depending on the type of opioid used, and they are insufficient compared to regional anesthesia methods.

Read the detailed description

The pericapsular nerve group (PENG) block has been reported as the first method to target the nerves that supply the hip capsule. Later, several studies said it was more effective than traditional peripheral nerve blocks at treating THA-related postoperative pain. However, a single-injection PENG block is only effective for a limited time. Little evidence supports the efficacy of continuous PENG block for postoperative pain management in THA.

Additional anesthetic techniques, such as peripheral nerve blocks, are part of the multimodal analgesic strategy and are often used to manage acute pain better. Inadequate treatment can lead to a persistent painful condition. Although numerous nerve blocks are available for this purpose, some may fail because they cover only some of the innervation of the anterior hip capsule. The trial hypothesizes that with continuous infusion of the pericapsular nerve group block (PENG block), defined in 2018, the four lateral cutaneous nerve blocks local anesthetic between the thigh-associated psoas muscle tendon plane, and the iliopubic eminence will provide adequate analgesia without causing a motor block. Compared to the infrainguinal approach, the fascia iliaca compartment block (FICB) provides better dissemination under the fascia iliaca, while the local anesthetic is administered more cranially. Desmet et al. showed that supra-inguinal FICB reduced morphine consumption and pain scores following THA. However, despite these promising results, obturator nerve block has not been clinically proven.

Total hip arthroplasties are necessary surgeries that can take steps to improve the quality of life and functional status of patients who do not respond to conservative treatments. However, patients may present with intense pain in the immediate postoperative period, resulting in inactivity, increased risk of complications, and greater opioid consumption, resulting in adverse effects and prolonged hospital stay. The challenging management of pain is explained by the complex innervation of the hip joint, in which the articular branches of the femoral, obturator, and accessory obturator nerves are responsible for the sensory innervation of the anterior capsule.

This randomized clinical trial hypothesizes that PENG block will provide better analgesia and result in fewer quadriceps muscle weakness than FICB following THA. Our preliminary results will be postoperative pain scores. Most anesthesia clinics routinely do this by diversifying these methods known after surgery. Traditional intravenous analgesia methods cause many undesirable side effects depending on the type of opioid used, and they are insufficient compared to regional anesthesia methods.

Since THA patients are generally elderly and with comorbidities, regional anesthesia techniques are safer and more effective.

This study focuses on two routine regional anesthesia techniques that can be safely applied. The trial aims to show which of these two methods is more effective.

Being tested
Periarticular nerve group block (PENG), Continuous supra-inguinal fascia iliaca compartment block (SIFICB)
Medical subject headings
Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Periarticular nerve group block (PENG)Procedure or surgery

    The pericapsular nerve group (PENG) block targets the nerves that supply the hip capsule. The continuous PENG block will be applied immediately after general anesthesia is given to the participants under ultrasound guidance. 30 ml of 0.25% bupivacaine will be used.

  • Continuous supra-inguinal fascia iliaca compartment block (SIFICB)Procedure or surgery

    The supra-inguinal fascia iliaca compartment block (SIFICB) targets the femoral, lateral femoral cutaneous, and obturator nerves. Under ultrasound guidance, 30 mL of 0.25% bupivacaine is administered, followed by catheter placement for continuous infusion at 5 mL/h.

Study groups in NCT06806865
Study groupRoleWhat they receive
PENG Group (periarticular nerve group)Active comparatorContinuous PENG block is the group to be applied.
Receives: Procedure: Periarticular nerve group block (PENG)
SIFICB Group (supra-inguinal fascia iliaca compartment block)Active comparatorContinuous supra-inguinal fascia iliaca compartment block is the group to be applied.
Receives: Procedure: Continuous supra-inguinal fascia iliaca compartment block (SIFICB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS scores

    The Visual Analogue Scale (VAS) measures pain intensity. It consists of a 10 cm line with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be'). Ask the patient to rate their current level of pain by placing a mark on the line. VAS scores at rest and during movement will be recorded at 0 hours (PACU), and subsequently at 2, 6, 12, and 24 hours while the patient is in the orthopedic clinic.

    Measured: up to 24 hours after recovery unit

Secondary outcomes (4)
  1. Total patient-controlled analgesia (PCA) consumption for 24 hours postoperatively

    A patient-controlled analgesia (PCA) pump is a safe way for people in pain to administer intravenous (I.V.) pain medicine (analgesia) when they need it. The pump holds a container filled with pain medicine, allowing the patient to control their pain. A total of 300 mg of tramadol will be used. 3mg/cc.

    Measured: Up to 24 hours

  2. intraoperative blood pressure

    Blood pressure will be monitored and recorded intermittently throughout the surgery. These parameters may be signs of pain.

    Measured: from the beginning of anesthesia induction to the leaving the recovery unit

  3. need for additional analgesia or rescue analgesia

    In cases where pain control is inadequate, when the PCA is locked and the VAS score is five or above, additional analgesics are administered. Paracetamol 15 mg/kg will be administered as rescue analgesia in the study.

    Measured: up to 24 hours after surgery

  4. intraoperative heart rate

    Heart rate will be monitored and recorded intermittently throughout the surgery. These parameters may be signs of pain.

    Measured: from the beginning of anesthesia induction up to leaving the recovery unit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start15 Mar 2023
  3. Primary completion15 Dec 2024
  4. Study completion15 Dec 2024

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06806865
Sponsor's protocol ID
2023.06.01.06
Acronym
PENG
Status last verified
May 2025
First submitted
30 Dec 2024
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Baran O, Sahin A, Arar C. Comparative analysis of continuous pericapsular nerve group block and supra-inguinal fascia iliaca compartment block for postoperative analgesia in total hip arthroplasty: a randomized controlled trial. J Orthop Surg Res. 2025 Aug 6;20(1):729. doi: 10.1186/s13018-025-06055-w.

    PubMed 40770360

Questions about this trial

What is this clinical trial studying?

A study testing Periarticular nerve group block (PENG) and Continuous supra-inguinal fascia iliaca compartment block (SIFICB) in people with Postoperative Pain and Regional Anesthesia, run by Namik Kemal 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 7 inclusion and 6 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 5 Jun 2025. 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?

VAS scores (time frame: up to 24 hours after recovery unit). 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 NCT06806865, which also lists 1 linked publication.

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 5 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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