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Hip Arthroplasty, TotalNCT07784192

Pericapsular Nerve Group Block Versus Intrathecal Morphine for Pain After Hip Surgery

A study testing Morpine, Ultrasound-guided pericapsular nerve group block and Bupivacaine in people with Hip Arthroplasty, Total and Postoperative Pain, run by Selcuk 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

Pain after hip replacement surgery is often severe and is commonly treated with opioids, which may cause nausea, vomiting, sedation, difficulty passing urine and slow breathing. This study will compare two ways of controlling pain in adults having hip surgery under spinal anesthesia. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Morpine, Ultrasound-guided pericapsular nerve group block and Bupivacaine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Aug 2026to 7 Oct 2026
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 65 years
  • American Society of Anesthesiologists physical status I, II or III
  • Scheduled for unilateral hip surgery under spinal anesthesia, including hip fracture surgery and hip replacement surgery
  • Able to understand and use the Visual Analog Scale and the patient-controlled analgesia device
  • Written informed consent

Who cannot join

  • Refusal to participate
  • Known allergy or hypersensitivity to local anesthetics, morphine or paracetamol
  • Any contraindication to spinal anesthesia, including coagulopathy, ongoing anticoagulant therapy, thrombocytopenia, infection at the puncture site, or raised intracranial pressure
  • Local infection or previous surgery at the pericapsular nerve group block site
  • Chronic opioid use or history of substance use disorder
  • Chronic pain requiring regular analgesic treatment before surgery
Show all 10Show fewer
  • Cognitive impairment, psychiatric disorder or communication difficulty preventing use of the pain scales
  • Pre-existing neurological deficit in the operative lower limb
  • Body mass index above 40 kg/m²
  • Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Selcuk University Hospital

    Konya, Selcuklu

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Post-operative Pain Management Methods in Patients Undergoing Total Hip Arthroplasty.

Pain after hip replacement surgery is often severe and is commonly treated with opioids, which may cause nausea, vomiting, sedation, difficulty passing urine and slow breathing. This study will compare two ways of controlling pain in adults having hip surgery under spinal anesthesia. One group will receive morphine added to the spinal injection. The other group will receive an ultrasound-guided pericapsular nerve group (PENG) block, in which local anesthetic is injected near the nerves that carry pain signals from the hip joint. Participants will be assigned to one of the two groups by chance. Sixty-four adults aged 18 to 65 years will take part, with 32 in each group. Pain scores at rest and during movement, the total amount of morphine used through a patient-controlled pump, the time until the first request for extra pain medicine, the amount of additional paracetamol used, side effects such as nausea and vomiting, and complications related to the block will be compared between the groups during the first 48 hours after surgery.

Read the detailed description

Postoperative pain after total hip arthroplasty is frequently severe and limits early mobilization. Systemic opioids remain widely used but are associated with respiratory depression, sedation, urinary retention, constipation and postoperative nausea and vomiting. Intrathecal morphine added to spinal anesthesia provides prolonged analgesia but shares these opioid-related adverse effects. The pericapsular nerve group (PENG) block, first described by Giron-Arango and colleagues, targets the articular branches of the femoral, obturator and accessory obturator nerves that supply the anterior hip capsule by injecting local anesthetic into the fascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Because the block spares motor fibers, it may provide effective analgesia without impairing early mobilization. Direct comparisons of the PENG block with intrathecal morphine in hip arthroplasty are limited.

This will be a prospective, randomized, controlled, open-label, single-center study conducted at Selcuk University Faculty of Medicine Hospital. Local ethics committee approval has been obtained, and written informed consent will be obtained from every participant before enrollment. Sixty-four patients aged 18 to 65 years with an American Society of Anesthesiologists physical status of I to III scheduled for unilateral hip surgery under spinal anesthesia will be allocated to one of two equal groups of 32 patients using a sealed-envelope randomization method, so that the allocation sequence is concealed from the investigator enrolling the patient. Owing to the nature of the interventions, participants, treating anesthesiologists and outcome assessors will not be blinded to group allocation. Before surgery, demographic data (age, height, weight, body mass index), comorbidities, physical status classification, type of surgery and fracture location will be recorded.

Peripheral venous access will be obtained with an 18 or 20 gauge cannula. Standard non-invasive monitoring of heart rate, systolic, diastolic and mean arterial pressures and peripheral oxygen saturation will be applied and recorded at predefined intervals from the intraoperative period until the 48th postoperative hour, with intraoperative measurements every 5 minutes. Spinal anesthesia will be performed in the sitting position under aseptic conditions at the L3-L4 or L4-L5 interspace using a 25 to 27 gauge, 90 mm Quincke spinal needle, after confirming free and clear cerebrospinal fluid flow.

Patients in Group 1 will receive 10 mg of hyperbaric bupivacaine 0.5% together with 100 micrograms of morphine hydrochloride into the intrathecal space. Patients in Group 2 will receive 10 mg of hyperbaric bupivacaine 0.5% intrathecally without morphine, followed by an ultrasound-guided PENG block on the operative side. For the block, patients will be placed supine and the area will be prepared with aseptic technique. A low-frequency (2 to 5 MHz) curvilinear ultrasound probe will be placed over the anterior inferior iliac spine and rotated approximately 45 degrees counterclockwise to align with the iliopubic eminence, visualizing the anterior inferior iliac spine, iliopubic eminence, iliopsoas tendon and femoral artery. A 21 gauge, 80 to 100 mm insulated, echogenic short-bevel needle will be advanced in-plane from lateral to medial until the tip lies in the plane between the iliopubic eminence and the iliopsoas tendon. After negative aspiration for blood and sonographic confirmation of needle position, 20 mL of 0.5% bupivacaine will be injected. Adequacy of the neuraxial block will be confirmed before surgery begins.

Postoperative analgesia will be provided with intravenous patient-controlled analgesia using morphine, programmed to deliver a 1 mg bolus dose with a 10-minute lockout interval and no background infusion. Intravenous paracetamol 1000 mg will be administered on demand as rescue analgesia, without exceeding a total daily dose of 4000 mg. Pain intensity at rest and on movement will be assessed with a Visual Analog Scale at the 1st, 3rd, 6th, 12th, 24th and 48th postoperative hours. Analgesic consumption, patient-controlled analgesia demand and delivery ratios, time to first rescue analgesic request, the incidence of nausea and vomiting, and block-related complications such as arterial puncture, hematoma, paresthesia during injection and signs of local anesthetic systemic toxicity will be recorded during the 0 to 1, 1 to 3, 3 to 6, 6 to 12, 12 to 24 and 24 to 48 hour intervals. Total analgesic consumption over 48 hours will also be recorded. Before every regional block, the expiry date and availability of 20% lipid emulsion will be checked, and the anesthesia machine, circuit leak test, defibrillator and emergency drug trolley will be verified.

The primary outcome will be cumulative morphine consumption during the first 24 postoperative hours. Secondary outcomes will include cumulative morphine consumption over 48 hours, pain scores at rest and on movement at each assessment point, time to first patient-controlled analgesia demand, total paracetamol consumption, incidence of postoperative nausea and vomiting and block-related complications.

Being tested
Morpine, Ultrasound-guided pericapsular nerve group block, Bupivacaine
Keywords
Arthroplasty, Hip Analgesia, Nerve Block
Medical subject headings
Pain, Postoperative, Agnosia, Hip Fractures

What participants receive

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

  • MorpineDrug

    Also called Morphine hydrochloride, ntrathecal morphine

    Preservative-free morphine hydrochloride 100 micrograms will be added to 10 mg of hyperbaric bupivacaine 0.5% and administered into the intrathecal space at the L3-L4 or L4-L5 interspace as part of spinal anesthesia.

  • Ultrasound-guided pericapsular nerve group blockProcedure or surgery

    After spinal anesthesia, an ultrasound-guided pericapsular nerve group block will be performed on the operative side. A 21 gauge, 80 to 100 mm echogenic needle will be advanced in-plane from lateral to medial into the fascial plane between the iliopubic eminence and the iliopsoas tendon, and 20 mL of bupivacaine 0.5% will be injected after negative aspiration.

  • BupivacaineDrug

    Also called Bupivacaine hydrochloride

    Hyperbaric bupivacaine 0.5%, 10 mg, will be administered intrathecally in both groups as the spinal anesthetic. In the PENG block group, an additional 20 mL of bupivacaine 0.5% will be used for the block.

Study groups in NCT07784192
Study groupRoleWhat they receive
Intrathecal Morphine GroupActive comparatorPatients receive spinal anesthesia with 10 mg hyperbaric bupivacaine 0.5% plus 100 micrograms of preservative-free morphine into the intrathecal space.
Receives: Drug: Morpine; Drug: Bupivacaine
PENG Block GroupExperimentalPatients receive spinal anesthesia with 10 mg hyperbaric bupivacaine 0.5% alone, followed by an ultrasound-guided pericapsular nerve group (PENG) block on the operated side with 20 mL of 0.5% bupivacaine.
Receives: Procedure: Ultrasound-guided pericapsular nerve group block; Drug: Bupivacaine

What is being measured

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

  1. Cumulative intravenous morphine consumption at 24 hours

    Total amount of morphine, in milligrams, delivered by the intravenous patient-controlled analgesia device during the first 24 postoperative hours, recorded from the device log. Lower values indicate lower opioid requirement.

    Measured: 0 to 24 hours after surgery

Secondary outcomes (7)
  1. Cumulative intravenous morphine consumption at 48 hours

    Total amount of morphine, in milligrams, delivered by the intravenous patient-controlled analgesia device during the first 48 postoperative hours, recorded from the device log. Lower values indicate lower opioid requirement.

    Measured: 0 to 48 hours after surgery

  2. Pain intensity at rest measured with the Visual Analog Scale

    Pain at rest is rated by the participant on a 0 to 100 mm Visual Analog Scale, where 0 mm indicates no pain and 100 mm indicates the worst imaginable pain. Lower scores indicate less pain.

    Measured: 1, 3, 6, 12, 24 and 48 hours after surgery

  3. Pain intensity on movement measured with the Visual Analog Scale

    Pain during passive flexion of the operated hip is rated by the participant on a 0 to 100 mm Visual Analog Scale, where 0 mm indicates no pain and 100 mm indicates the worst imaginable pain. Lower scores indicate less pain.

    Measured: 1, 3, 6, 12, 24 and 48 hours after surgery

  4. Time to first patient-controlled analgesia demand

    Time in minutes from the end of the intrathecal injection to the first demand recorded by the patient-controlled analgesia device. Longer times indicate a longer duration of analgesia.

    Measured: 0 to 48 hours after surgery

  5. Cumulative paracetamol consumption

    Total amount of intravenous paracetamol, in milligrams, administered on demand as rescue analgesia during the first 48 postoperative hours, with a maximum of 4000 mg per day. Lower values indicate lower rescue analgesic requirement.

    Measured: 0 to 48 hours after surgery

  6. Number of participants with postoperative nausea and vomiting

    Number of participants experiencing nausea, vomiting or both, and the number requiring antiemetic treatment, recorded at each assessment interval.

    Measured: 0 to 48 hours after surgery

  7. Number of participants with block-related complications

    Number of participants with arterial puncture, hematoma, paresthesia during injection, quadriceps weakness, or clinical signs of local anesthetic systemic toxicity such as perioral numbness, tinnitus, seizure or arrhythmia.

    Measured: 0 to 48 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 posted25 Aug 2026
  2. Study start24 Aug 2026
  3. Primary completion4 Oct 2026
  4. Study completion7 Oct 2026

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
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07784192
Sponsor's protocol ID
SU-ANES-2025-711
Status last verified
Oct 2026
First submitted
18 Aug 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu SS, Wu CL. The effect of analgesic technique on postoperative patient-reported outcomes including analgesia: a systematic review. Anesth Analg. 2007 Sep;105(3):789-808. doi: 10.1213/01.ane.0000278089.16848.1e.

    PubMed 17717242
  • 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
  • Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.

    PubMed 29140962
  • Pivec R, Issa K, Naziri Q, Kapadia BH, Bonutti PM, Mont MA. Opioid use prior to total hip arthroplasty leads to worse clinical outcomes. Int Orthop. 2014 Jun;38(6):1159-65. doi: 10.1007/s00264-014-2298-x. Epub 2014 Feb 27.

    PubMed 24573819

Questions about this trial

What is this clinical trial studying?

A study testing Morpine, Ultrasound-guided pericapsular nerve group block and Bupivacaine in people with Hip Arthroplasty, Total and Postoperative Pain, run by Selcuk 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 5 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: finished, as of the sponsor's last update on 8 Oct 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?

Cumulative intravenous morphine consumption at 24 hours (time frame: 0 to 24 hours after surgery). 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 NCT07784192, 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 8 Oct 2026.

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