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Perioperative AnalgesiaNCT07449585

Pericapsular Nerve Group Block Versus Intrathecal Morphine for Analgesia After Total Hip Arthroplasty

A study testing PNEG block, Spinal anesthesia with opioid and Spinal anesthesia without opioid in people with Perioperative Analgesia and Hip Replacement, Total, run by Medical University of Gdansk.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The Pericapsular Nerve Group (PENG) block is an effective method for postoperative pain management in patients undergoing primary total hip arthroplasty (THA) via a posterolateral approach. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PNEG block, Spinal anesthesia with opioid and Spinal anesthesia without opioid
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
No sites listed yet
Study dates
1 Mar 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed, written consent for study participation.
  • Qualification for elective primary total hip arthroplasty via a posterolateral approach.
  • Age above 18 years.
  • ASA Physical Status I-III.
  • Absence of contraindications to spinal anesthesia.
  • Absence of contraindications to performing a Pericapsular Nerve Group (PENG) block.
  • Absence of contraindications to the administration of the pharmacological agents utilized in the study.

Who cannot join

  • Absence of informed consent.
  • Age below 18 years.
  • Psychoactive substance abuse or dependence.
  • Chronic opioid therapy.
  • Contraindications to spinal anesthesia.
  • Contraindications to the Pericapsular Nerve Group (PENG) block.
Show all 10Show fewer
  • Contraindications to the administration of study medications.
  • Body Mass Index (BMI) above 30 kg/m^2.
  • Pregnancy.
  • History of chronic pain management.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mykhailo Kazantsev, MD contact

00 48 56 641 4039

mykhailo.kazantsev@gmail.com

About this study

Official title: Comparison of the Efficacy of the Pericapsular Nerve Group (PENG) Block Versus Intrathecal Morphine for Postoperative Analgesia Following Total Hip Arthroplasty

The Pericapsular Nerve Group (PENG) block is an effective method for postoperative pain management in patients undergoing primary total hip arthroplasty (THA) via a posterolateral approach. The application of this technique reduces postoperative opioid requirements, thereby limiting the risk of adverse effects associated with systemic opioid administration. Effective pain control and a reduced incidence of side effects may translate into higher patient satisfaction and a decreased length of hospital stay (LOS). The PENG block serves as an effective component of multimodal analgesia and may provide an alternative to intrathecal morphine in patients undergoing primary total hip arthroplasty via a posterolateral approach, where the primary anesthetic technique is spinal anesthesia with hyperbaric bupivacaine.

Objectives

  1. To evaluate the efficacy of the PENG block in postoperative pain control and compare its effectiveness with intrathecal morphine administration.
  2. To assess the impact of the PENG block on postoperative opioid consumption in comparison to analgesia achieved via intrathecal morphine.
  3. To analyze the incidence of selected adverse effects associated with systemic opioid administration in patients receiving a PENG block versus those in the intrathecal morphine group.
  4. To evaluate patient satisfaction levels regarding postoperative pain management across the different analgesic modalities.
  5. To analyze the correlation between the type of analgesia employed and the duration of hospitalization.
Being tested
PNEG block, Spinal anesthesia with opioid, Spinal anesthesia without opioid, Sham PENG block
Keywords
Pericapsular Nerve Group Block, Intrathecal Morphine, Spinal Anesthesia, Total Hip Arthroplasty, Postoperative Pain, Postoperative Analgesia, Opioid Consumption, Patient-Controlled Analgesia
Medical subject headings
Pain, Postoperative

What participants receive

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

  • PNEG blockProcedure or surgery

    Pericapsular Nerve Group (PENG) block will be performed using 20 mL of 0.5% ropivacaine (Ropimol, Molteni, Italy), supplemented with 4 mg of dexamethasone (Dexaven, Bausch Health, Ireland).

  • Spinal anesthesia with opioidProcedure or surgery

    Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine, supplemented with 100 mcg of morphine (Morphini Sulfas WZF 0.1% Spinal, Polpharma, Poland).

  • Spinal anesthesia without opioidProcedure or surgery

    Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine (Marcaine Spinal 0.5% Heavy, Aspen Pharma, Ireland).

  • Sham PENG blockProcedure or surgery

    A sham PENG block will be performed using 20 mL of 0.9% sodium chloride solution (Natrium chloratum 0,9% Fresenius, Fresenius Kabi, Poland).

Study groups in NCT07449585
Study groupRoleWhat they receive
PENG GroupExperimentalSpinal anesthesia without opioid + PENG block
Receives: Procedure: PNEG block; Procedure: Spinal anesthesia without opioid
MF GroupActive comparatorSpinal anesthesia with opioid and sham PENG Block
Receives: Procedure: Spinal anesthesia with opioid; Procedure: Sham PENG block
ControlSham comparatorSpinal anesthesia without opioid and sham PENG Block
Receives: Procedure: Spinal anesthesia without opioid; Procedure: Sham PENG block

What is being measured

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

  1. Cumulative oxycodone consumption delivered via patient-controlled analgesia (PCA)

    Total amount of oxycodone delivered by the intravenous PCA pump, calculated as the sum of all delivered PCA boluses and reported in milligrams. Lower values indicate lower postoperative opioid requirement.

    Measured: From end of surgery to 24 hours postoperatively.

  2. Number of patient-initiated PCA demand attempts recorded by the PCA pump

    Total number of patient-initiated analgesia requests (button presses) recorded by the intravenous patient-controlled analgesia (PCA) pump. This measure includes all demand attempts, regardless of whether a bolus was delivered. Reported as count.

    Measured: From end of surgery to 24 hours postoperatively.

  3. Pain intensity at rest measured by the 11-point Numerical Rating Scale (NRS, 0-10)

    Patient-reported pain intensity at rest assessed using the 11-point Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain score is recorded at each scheduled assessment time point.

    Measured: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.

  4. Dynamic pain assesmnetDynamic pain intensity during passive straight leg raise measured by the 11-point Numerical Rating Scale (NRS, 0-10)

    Patient-reported dynamic pain intensity during passive straight leg raise of the operated limb (knee extended and hip flexed to 45°), assessed using the 11-point Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain score is recorded at each scheduled assessment time point.

    Measured: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.

  5. Patient satisfaction with postoperative analgesia measured by a 5-point Likert satisfaction scale (1-5)

    Patient-reported satisfaction with postoperative analgesia assessed using a 5-point Likert satisfaction scale:

    1. = definitely dissatisfied,
    2. = dissatisfied,
    3. = neither satisfied nor dissatisfied (neutral),
    4. = satisfied,
    5. = definitely satisfied. Higher scores indicate greater satisfaction.

    Measured: At 0, 4, 8, 12, and 24 hours after surgery.

Secondary outcomes (17)
  1. Nausea severity

    Assessment via a Visual Analogue Scale (VAS), where "0" indicates no nausea and "10" indicates the most severe nausea

    Measured: Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively

  2. Pruritus Severity

    Assessment via a Visual Analogue Scale (VAS), where "0" indicates no pruritus and "10" indicates the worst possible itching

    Measured: Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively

  3. Postoperative length of hospital stay (days)

    Duration from hospital admission to hospital discharge, reported in days.

    Measured: From hospital admission to hospital discharge (assessed at hospital discharge).

  4. Sedation and agitation level measured by the Richmond Agitation-Sedation Scale (RASS, -5 to +4)

    Sedation/agitation is assessed using the Richmond Agitation-Sedation Scale (RASS), ranging from -5 to +4, where:

    • 5 = unarousable,
    • 4 = deep sedation,
    • 3 = moderate sedation,
    • 2 = light sedation,
    • 1 = drowsy, 0 = alert and calm,
    • 1 = restless,
    • 2 = agitated,
    • 3 = very agitated,
    • 4 = combative. Higher scores indicate greater agitation; lower scores indicate deeper sedation. For postoperative recovery, scores closer to 0 are considered more favorable, while scores further from 0 indicate a less favorable state.

    Measured: At 0, 4, 8, 12, and 24 hours after surgery.

  5. Motor blockade measured by the Bromage motor blockade scale (Grade 0-3)

    Motor blockade is assessed using the Bromage motor blockade scale from Grade 0 to Grade 3, where:

    Grade 0 = no motor blockade (full movement at knee and ankle joints), Grade 1 = partial block (limited/simple knee movement, full foot movement), Grade 2 = almost complete block (no knee movement, preserved foot movement), Grade 3 = complete block (no movement of lower limbs, including knees and feet).

    Higher grades indicate greater motor blockade (worse motor function). Lower grades indicate less motor blockade (better motor function recovery).

    Measured: At 0, 4, 8, 12, and 24 hours after surgery.

  6. Sensory blockade

    Evaluation of the spinal anesthesia level based on thermal sensation (using an antiseptic spray)

    Measured: At 0, 4, 8, 12, and 24 hours postoperatively.

  7. Antiemetic Consumption

    Total dose of ondansetron and/or other antiemetics administered.

    Measured: Within the first 24 hours following the completion of surgery

  8. Intraoperative blood loss (mL)

    Estimated blood loss during surgery, reported in milliliters (mL).

    Measured: Intraoperatively (from skin incision to skin closure).

  9. Duration of surgery (minutes)

    Time from skin incision to skin closure, reported in minutes.

    Measured: Intraoperatively (from skin incision to skin closure).

  10. Participants requiring intraoperative vasopressors

    Number of participants who required at least one vasopressor dose during surgery, reported as count.

    Measured: Intraoperatively (from skin incision to skin closure).

  11. Heart rate (beats per minute)

    Heart rate measured by bedside monitoring and reported in beats per minute (bpm).

    Measured: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.

  12. Peripheral oxygen saturation (SpO2, %)

    Peripheral oxygen saturation measured by pulse oximetry and reported as percent (%).

    Measured: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.

  13. Diastolic blood pressure (DBP, mmHg)

    Non-invasive diastolic blood pressure measured with an automated cuff and reported in mmHg.

    Measured: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.

  14. Mean arterial pressure (MAP, mmHg)

    Mean arterial pressure reported in mmHg at each assessment time point (device-reported value or calculated from SBP and DBP, per site standard).

    Measured: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.

  15. Time to first mobilization (hours)

    Time interval from administration of spinal anesthesia to first mobilization, defined as first upright positioning and/or ambulation, reported in hours.

    Measured: From administration of spinal anesthesia until hospital discharge (time to first mobilization assessed at first mobilization, through study completion an average of 24 hours postoperatively).

  16. Number of participants with predefined anesthesia-related complications

    Number of participants with at least one predefined anesthesia-related complication, including accidental vascular puncture, local anesthetic systemic toxicity (LAST), and respiratory failure. Reported as count.

    Measured: From hospital admission to hospital discharge (assessed daily during hospitalization and at discharge, through study completion an average 5 days postoperatively).

  17. Number of participants with predefined hospitalization-related complications

    Number of participants with at least one predefined hospitalization-related complication, including requirement for blood product transfusion, pneumonia, cardiovascular events, and surgical site infection (SSI). Reported as count.

    Measured: From hospital admission to hospital discharge (assessed daily during hospitalization and at discharge, through study completion an average 5 days postoperatively).

Timeline

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

  1. First posted4 Mar 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

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, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07449585
Sponsor's protocol ID
GRU/KAZ/1
Status last verified
Feb 2026
First submitted
5 Feb 2026
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PNEG block, Spinal anesthesia with opioid and Spinal anesthesia without opioid in people with Perioperative Analgesia and Hip Replacement, Total, run by Medical University of Gdansk.

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 10 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: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mykhailo Kazantsev, MD (00 48 56 641 4039, mykhailo.kazantsev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative oxycodone consumption delivered via patient-controlled analgesia (PCA) (time frame: From end of surgery to 24 hours postoperatively.). The study lists 5 primary outcomes in all. 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 4 Mar 2026.

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