Total Hip ArthroplastyPhase 4NCT05308420

PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

A Phase 4 study testing Pericapsular nerve group (PENG) block, Spinal anesthesia and Intrathecal morphine in people with Total Hip Arthroplasty and Postoperative Pain, run by Kresimir Oremus, MD at 1 site in Croatia.

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

To compare the impact of pericapsular nerve group (PENG) block to intrathecal morphine on postoperative analgesia, motor function and side effects in patients undergoing primary total hip arthroplasty under spinal anesthesia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Total Hip Arthroplasty, Postoperative Pain
What is being tested?: Pericapsular nerve group (PENG) block, Spinal anesthesia and Intrathecal morphine
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteCroatia
Study dates: 3 Apr 2022to 1 Dec 2022
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients with osteoarthritis of the hip scheduled for primary total hip arthroplasty under spinal anesthesia able to provide written informed consent

Who cannot join

patient unwilling / unable to provide informed consent
contraindications for any of the drugs and procedures included in the study protocol (allergies, local infection, coagulopathy)
high risk for perioperative morbidity/mortality (ASA Physical Status Classification IV)
preoperative use of strong opioid analgesia (due to hip pain or other acute/chronic pain condition)
pregnancy
substance abuse

Show all 9Show fewer

Post Randomization Exclusion Criteria:
change of surgical plan
violation of study protocol

Trial locations and contacts

1 site in 1 country.

Croatia1 site

Akromion Special Hospital for Orthopedic Surgery
Krapinske Toplice, 49217

Other trials in Croatia

About this study

Official title: Pericapsular Nerve Group (PENG) Block vs Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: a Randomized Non-inferiority Trial

Read the detailed description

The study aims to confirm the non-inferiority of PENG block vs intrathecal morphine in patients undergoing total hip arthroplasty under spinal anesthesia. Non-inferiority will be assessed regarding maximum pain on a numerical rating scale at rest and during active hip flexion and regarding cumulative morphine consumption during 48 postoperative hours. Impact on quadriceps muscle motor function and side effects including pruritus, nausea and vomiting and hypotension will also be assessed.

Conditions: Total Hip Arthroplasty, Postoperative Pain
Being tested: Pericapsular nerve group (PENG) block, Spinal anesthesia, Intrathecal morphine, Sham PENG block, Intrathecal placebo
Keywords: Total hip arthroplasty, Postoperative pain, Anesthesia, Regional
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
A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and 20ml 0.5% levobupivacaine with 2mg (0.5ml) dexamethasone injected (total volume of injectate 20.5ml) between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule
Spinal anesthesiaProcedure or surgery
Spinal anesthesia will be performed at the level of the presumed interspace in-between the third and fourth lumbar vertebrae by introducing a 27 gauge pencil-point spinal needle and 15mg of levobupivacaine (3ml) injected intrathecally
Intrathecal morphineDrug
100 micrograms of preservative free morphine diluted to a volume of 0.5ml is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)
Sham PENG blockProcedure or surgery
A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and a placebo solution consisting of 20.5ml 0.9%NaCl injected between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule
Intrathecal placeboDrug
0.5ml of placebo solution (0.9%NaCl) is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)

Study groups in NCT05308420
Study group	Role	What they receive
PENG block	Active comparator	Patients scheduled for primary total hip arthroplasty after receiving spinal anesthesia will undergo pericapsular nerve group (PENG) block. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone Receives: Procedure: Pericapsular nerve group (PENG) block; Procedure: Spinal anesthesia; Drug: Intrathecal placebo
Intrathecal morphine	Active comparator	Patients scheduled for primary total hip arthroplasty will receive spinal anesthesia with local anesthetic and morphine administered intrathecally. After onset of spinal anesthesia a sham PENG block will be performed. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone. Receives: Procedure: Spinal anesthesia; Drug: Intrathecal morphine; Procedure: Sham PENG block

What is being measured

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

Maximum pain at rest
maximum pain on a numerical rating scale at rest over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Measured: 48 postoperative hours
Maximum pain with active hip flexion
maximum pain on a numerical rating scale with active 60 degrees hip flexion over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Measured: 48 postoperative hours
cumulative morphine equivalent dose over 48 post-operative hours
cumulative opioid consumption including morphine rescue analgesia will be recorded during the first 48 postoperative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Measured: 48 postoperative hours

Secondary outcomes (2)

Quadriceps muscle motor block
Quadriceps muscle motor function will be evaluated by a straight leg raise test performed at 4,6,12,20 and 24 hours postoperatively
Measured: 24 postoperative hours
Opioid side effects
The presence of pruritus, nausea and vomiting, hypotension and need for rescue antiemetic medication (ondansetron) will be monitored and recorded
Measured: 48 postoperative hours

Timeline

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

3 Apr 20221 Dec 2022

First posted4 Apr 2022
Study start3 Apr 2022
Primary completion1 Dec 2022
Study completion1 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Non-inferiority randomized triple-blinded controlled trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05308420
Sponsor's protocol ID: 022021
Status last verified: Dec 2022
First submitted: 18 Mar 2022
Last updated: 20 Dec 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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
Hess SR, Lahaye LA, Waligora AC, Sima AP, Jiranek WA, Golladay GJ. Safety and side-effect profile of intrathecal morphine in a diverse patient population undergoing total knee and hip arthroplasty. Eur J Orthop Surg Traumatol. 2019 Jan;29(1):125-129. doi: 10.1007/s00590-018-2293-9. Epub 2018 Aug 13.
PubMed 30105593
Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20.
PubMed 34015859
Oremus K, Trkulja V, Gasparini G, Sostaric S, Cicak N, Haspl M, Mihaljevic S. Pericapsular nerve group (PENG) block compared to intrathecal morphine for analgesic efficacy in total hip arthroplasty: A placebo-controlled randomized double-blind non-inferiority trial. J Clin Anesth. 2025 Sep;106:111921. doi: 10.1016/j.jclinane.2025.111921. Epub 2025 Jul 2.
PubMed 40609218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)

All Total Hip Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pericapsular Nerve Group (PENG) Block vs Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: a Randomized Non-inferiority Trial
ClinicalTrials.gov ID: NCT05308420
Acronym / sponsor ID: 022021
Conditions: Total Hip Arthroplasty, Postoperative Pain
Keywords: Total hip arthroplasty, Postoperative pain, Anesthesia, Regional
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Kresimir Oremus, MDUniversity, hospital or other
Study start: 3 Apr 2022 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 4 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Non-inferiority randomized triple-blinded controlled trial

Arm	Type	Receives
PENG block	Active comparator	Procedure: Pericapsular nerve group (PENG) block, Procedure: Spinal anesthesia, Drug: Intrathecal placeboPatients scheduled for primary total hip arthroplasty after receiving spinal anesthesia will undergo pericapsular nerve group (PENG) block. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone
Intrathecal morphine	Active comparator	Procedure: Spinal anesthesia, Drug: Intrathecal morphine, Procedure: Sham PENG blockPatients scheduled for primary total hip arthroplasty will receive spinal anesthesia with local anesthetic and morphine administered intrathecally. After onset of spinal anesthesia a sham PENG block will be performed. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

adult patients with osteoarthritis of the hip scheduled for primary total hip arthroplasty under spinal anesthesia able to provide written informed consent

Key exclusion criteria (9 listed)

patient unwilling / unable to provide informed consent
contraindications for any of the drugs and procedures included in the study protocol (allergies, local infection, coagulopathy)
high risk for perioperative morbidity/mortality (ASA Physical Status Classification IV)
preoperative use of strong opioid analgesia (due to hip pain or other acute/chronic pain condition)
pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pericapsular nerve group (PENG) blockA 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and 20ml 0.5% levobupivacaine with 2mg (0.5ml) dexamethasone injected (total volume of injectate 20.5ml) between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule	Procedure or surgery	PENG block
Spinal anesthesiaSpinal anesthesia will be performed at the level of the presumed interspace in-between the third and fourth lumbar vertebrae by introducing a 27 gauge pencil-point spinal needle and 15mg of levobupivacaine (3ml) injected intrathecally	Procedure or surgery	Intrathecal morphine, PENG block
Intrathecal morphine100 micrograms of preservative free morphine diluted to a volume of 0.5ml is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)	Drug	Intrathecal morphine
Sham PENG blockA 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and a placebo solution consisting of 20.5ml 0.9%NaCl injected between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule	Procedure or surgery	Intrathecal morphine
Intrathecal placebo0.5ml of placebo solution (0.9%NaCl) is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)	Drug	PENG block

Primary outcome

Maximum pain at rest
Time frame: 48 postoperative hours
maximum pain on a numerical rating scale at rest over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Maximum pain with active hip flexion
Time frame: 48 postoperative hours
maximum pain on a numerical rating scale with active 60 degrees hip flexion over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
cumulative morphine equivalent dose over 48 post-operative hours
Time frame: 48 postoperative hours
cumulative opioid consumption including morphine rescue analgesia will be recorded during the first 48 postoperative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes

2 secondary outcomes

Quadriceps muscle motor block
Time frame: 24 postoperative hours
Opioid side effects
Time frame: 48 postoperative hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
Background: PubMed 30063657Giron-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.
Background: PubMed 30105593Hess SR, Lahaye LA, Waligora AC, Sima AP, Jiranek WA, Golladay GJ. Safety and side-effect profile of intrathecal morphine in a diverse patient population undergoing total knee and hip arthroplasty. Eur J Orthop Surg Traumatol. 2019 Jan;29(1):125-129. doi: 10.1007/s00590-018-2293-9. Epub 2018 Aug 13.
Background: PubMed 34015859Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20.
Derived from this study: PubMed 40609218Oremus K, Trkulja V, Gasparini G, Sostaric S, Cicak N, Haspl M, Mihaljevic S. Pericapsular nerve group (PENG) block compared to intrathecal morphine for analgesic efficacy in total hip arthroplasty: A placebo-controlled randomized double-blind non-inferiority trial. J Clin Anesth. 2025 Sep;106:111921. doi: 10.1016/j.jclinane.2025.111921. Epub 2025 Jul 2.
Individual participant dataSharing planned: No

Related trials for Total Hip Arthroplasty

Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 9 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 20 Dec 2022. 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 Croatia. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Maximum pain at rest (time frame: 48 postoperative hours). The study lists 3 primary outcomes in all. 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 NCT05308420, 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 20 Dec 2022.