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Postoperative PainNCT07803133

PENG Block Versus Intrathecal Morphine for Early Postoperative Recovery After Total Hip Arthroplasty

A study testing Pericapsular nerve group (PENG) block and Intrathecal Morphine in people with Postoperative Pain, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).

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 goal of this clinical trial is to compare the PENG block with intrathecal morphine for early postoperative recovery and pain control in adults undergoing elective total hip arthroplasty. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Postoperative Pain
What is being tested?
Pericapsular nerve group (PENG) block and Intrathecal Morphine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2026to 1 Sep 2027
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-85 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective primary unilateral total hip arthroplasty
  • Planned spinal anesthesia
  • Ability to understand and complete the Quality of Recovery-15 (QoR-15) questionnaire and Numeric Rating Scale (NRS) pain assessments
  • Provision of written informed consent

Who cannot join

  • Contraindication to spinal anesthesia or PENG block
  • Known allergy or hypersensitivity to local anesthetics or morphine
  • Coagulation disorder
  • Therapeutic anticoagulant use
  • Infection at the planned injection site
  • Chronic opioid use
Show all 15Show fewer
  • History of substance abuse
  • Severe cognitive impairment that prevents reliable completion of study assessments
  • Advanced hepatic or renal failure
  • ASA physical status IV or higher
  • Revision total hip arthroplasty
  • Surgery for pathological fracture or tumor
  • Pregnancy
  • Requirement for general anesthesia
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ayşe Meryem Yalçın, MD contact

+905544035688

aysmrym1@gmail.com

Turkey (Türkiye)1 site
  • Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital

    Erzincan, Erzincan, 06170

    Ayşe Meryem Yalçın, MD, +905544035688, aysmrym1@gmail.com

    Ayşe Meryem Yalçın, MD

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of PENG Block and Intrathecal Morphine in Terms of Early Postoperative Quality of Recovery and Analgesic Efficacy in Patients Undergoing Elective Total Hip Arthroplasty: A Prospective Randomized Controlled Trial

The goal of this clinical trial is to compare the PENG block with intrathecal morphine for early postoperative recovery and pain control in adults undergoing elective total hip arthroplasty. The main question it aims to answer is:

Is there a difference between PENG block and intrathecal morphine in quality of recovery 24 hours after surgery, as measured by the Quality of Recovery-15 (QoR-15) questionnaire?

Read more

Researchers will also compare postoperative pain, opioid use, mobilization, motor function, and treatment-related side effects between the two groups.

Participants will be randomly assigned to receive either a PENG block or intrathecal morphine in addition to spinal anesthesia and standard multimodal pain treatment. Participants will complete the QoR-15 questionnaire before surgery and 24 hours after surgery. Pain scores, opioid use, mobilization, motor function, and side effects will be assessed during the first 24 hours after surgery.

Read the detailed description

Total hip arthroplasty is a major orthopedic procedure associated with substantial postoperative pain, which may interfere with early mobilization, functional recovery, and overall quality of recovery. Effective multimodal analgesia is therefore an important component of perioperative care. Intrathecal morphine provides prolonged postoperative analgesia but may be associated with opioid-related adverse effects, including nausea and vomiting, pruritus, urinary retention, and respiratory depression. The pericapsular nerve group (PENG) block is a regional analgesic technique targeting the sensory innervation of the anterior hip capsule and has been proposed as a potentially motor-sparing approach to analgesia after hip surgery.

This is a prospective, randomized, controlled, assessor-blinded, single-center clinical trial comparing PENG block with intrathecal morphine in patients undergoing elective primary unilateral total hip arthroplasty under spinal anesthesia. A total of 90 participants will be enrolled and randomly assigned in a 1:1 ratio using computer-generated randomization. Allocation will be concealed using sealed opaque envelopes. Because of the nature of the interventions, the anesthesiologist performing the procedures cannot be blinded. Investigators performing postoperative assessments and the investigator performing the statistical analysis will be blinded to group allocation.

Perioperative anesthesia and analgesia will be standardized for both groups. All participants will undergo routine standard monitoring and receive spinal anesthesia with 10-15 mg of 0.5% hyperbaric bupivacaine. All participants will also receive 8 mg of intravenous dexamethasone intraoperatively.

Participants assigned to the PENG group will receive an ultrasound-guided PENG block with a total injectate volume of 20 mL. The intended PENG block dose will be 100 mg of bupivacaine (20 mL of 0.5% bupivacaine). For safety, the bupivacaine dose will be reduced when necessary to ensure that the total bupivacaine dose, including the dose administered for spinal anesthesia, does not exceed 2 mg/kg. When dose reduction is required, an appropriate volume of 0.5% bupivacaine will be combined with 0.9% saline to maintain a total PENG block injectate volume of 20 mL.

Participants assigned to the intrathecal morphine group will receive 100 micrograms of preservative-free intrathecal morphine during spinal anesthesia. Apart from the randomized analgesic intervention, perioperative management will be standardized between the two groups.

Postoperative multimodal analgesia will be standardized for all participants. Paracetamol 1 g will be administered intravenously or orally every 8 hours, and dexketoprofen trometamol 50 mg will be administered intravenously every 12 hours. Rescue analgesia will consist of intravenous tramadol 1 mg/kg when the Numeric Rating Scale (NRS) pain score is 4 or higher. Postoperative opioid consumption will be recorded and converted to morphine-equivalent doses.

The study is designed to compare the effects of these two analgesic strategies on early patient-centered recovery after total hip arthroplasty while also evaluating their analgesic, functional, and adverse-effect profiles. Recovery status will be assessed before surgery to account for individual differences in baseline recovery-related health status, and postoperative assessments will be performed by investigators blinded to treatment allocation.

Being tested
Pericapsular nerve group (PENG) block, Intrathecal Morphine
Keywords
Total Hip Arthroplasty, PENG Block, Intrathecal Morphine, Quality of Recovery, QoR-15, Postoperative 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.

  • Pericapsular nerve group (PENG) blockProcedure or surgery

    Participants will receive an ultrasound-guided pericapsular nerve group (PENG) block after spinal anesthesia. The total injectate volume will be 20 mL, with an intended dose of 100 mg bupivacaine (20 mL of 0.5% bupivacaine). The bupivacaine dose will be reduced when necessary to ensure that the total bupivacaine dose, including the dose administered for spinal anesthesia, does not exceed 2 mg/kg. When dose reduction is required, 0.9% saline will be added to maintain a total injectate volume of 20 mL.

  • Intrathecal MorphineDrug

    100 micrograms of preservative-free morphine administered intrathecally during spinal anesthesia

Study groups in NCT07803133
Study groupRoleWhat they receive
PENG Block GroupExperimentalParticipants assigned to this group will receive an ultrasound-guided PENG block after spinal anesthesia. The PENG block will have a total injectate volume of 20 mL, with an intended dose of 100 mg bupivacaine (20 mL of 0.5% bupivacaine). The bupivacaine dose will be reduced when necessary to ensure that the total bupivacaine dose, including the dose administered for spinal anesthesia, does not exceed 2 mg/kg. When dose reduction is required, 0.9% saline will be added to maintain a total injectate volume of 20 mL. All other perioperative anesthesia and multimodal analgesia will be standardized.
Receives: Procedure: Pericapsular nerve group (PENG) block
Intrathecal Morphine GroupExperimentalParticipants assigned to this group will receive 100 micrograms of preservative-free intrathecal morphine during spinal anesthesia. All other perioperative anesthesia and multimodal analgesia will be standardized.
Receives: Drug: Intrathecal Morphine

What is being measured

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

  1. Quality of Recovery-15 (QoR-15) Score at 24 Hours After Surgery

    Quality of recovery will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery. The questionnaire will be administered preoperatively to assess baseline recovery status and repeated 24 hours after surgery. The primary outcome will be the QoR-15 score at 24 hours after surgery.

    Measured: 24 hours after surgery

Secondary outcomes (10)
  1. Pain at Rest Assessed by the Numeric Rating Scale (NRS)

    Pain at rest will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A preoperative measurement will be obtained as the baseline value, and postoperative measurements will be compared with baseline and between the study groups.

    Measured: Preoperatively and at 3, 6, 12, and 24 hours after surgery

  2. Pain During Straight Leg Raise Assessed by the Numeric Rating Scale (NRS)

    Pain during active straight leg raise will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A preoperative measurement will be obtained as the baseline value, and postoperative measurements will be compared with baseline and between the study groups.

    Measured: Preoperatively and at 3, 6, 12, and 24 hours after surgery

  3. Cumulative Postoperative Opioid Consumption

    Total opioid consumption during the first 24 hours after surgery will be recorded. Administered opioids will be converted to intravenous morphine-equivalent doses for comparison between groups.

    Measured: From the end of surgery to 24 hours after surgery

  4. Time to First Postoperative Mobilization

    Time from the end of surgery to the participant's first postoperative mobilization will be recorded.

    Measured: From the end of surgery to first mobilization, assessed up to 24 hours after surgery

  5. Overall Benefit of Analgesia Score (OBAS)

    Overall postoperative analgesic benefit will be assessed using the Overall Benefit of Analgesia Score (OBAS), a 7-item multidimensional instrument that incorporates pain intensity, opioid-related adverse effects, and patient satisfaction with pain treatment. The total OBAS ranges from 0 to 28, with lower scores indicating a greater overall benefit of analgesia and higher scores indicating a worse outcome.

    Measured: 24 hours after surgery

  6. Incidence of Postoperative Nausea and Vomiting

    The number of participants experiencing postoperative nausea and/or vomiting will be recorded.

    Measured: Within the first 24 hours after surgery

  7. Incidence of Pruritus

    The number of participants experiencing pruritus during the postoperative period will be recorded.

    Measured: Within the first 24 hours after surgery

  8. Incidence of Urinary Retention

    The number of participants experiencing postoperative urinary retention will be recorded.

    Measured: Within the first 24 hours after surgery

  9. Incidence of Respiratory Depression

    The number of participants experiencing postoperative respiratory depression will be recorded.

    Measured: Within the first 24 hours after surgery

  10. Ability to Perform Active Straight Leg Raise

    Motor function will be assessed by the participant's ability to actively raise the operated leg from the bed with the knee extended. The assessment will be recorded as successful or unsuccessful.

    Measured: Preoperatively and at 3, 6, 12, and 24 hours after surgery

Timeline

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

  1. First posted3 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2027 (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
Model description
Participants will be randomized in a 1:1 ratio to receive either an ultrasound-guided PENG block or intrathecal morphine as part of the perioperative analgesic strategy for total hip arthroplasty.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07803133
Sponsor's protocol ID
2026-10/02
Status last verified
Aug 2026
First submitted
31 Aug 2026
Last updated
9 Sep 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 Pericapsular nerve group (PENG) block and Intrathecal Morphine in people with Postoperative Pain, run by Erzincan Binali Yildirim Universitesi 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 6 inclusion and 15 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 9 Sep 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?

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 Ayşe Meryem Yalçın, MD (+905544035688, aysmrym1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery-15 (QoR-15) Score at 24 Hours After Surgery (time frame: 24 hours after surgery). 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 9 Sep 2026.

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