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Opioid Consumption, PostoperativeNCT06821516

Comparison of Pain Relief Methods for Hip Surgery: A Study on Two Different Nerve Block Techniques

A study testing Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesia and Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesia in people with Opioid Consumption, Postoperative and Pain, Postoperative, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective randomized comparative study aims to compare the analgesic efficacy of pericapsular nerve group block (PENG) and lumbar erector spinae plane block (L-ESP) groups to relieve postoperative pain in participants over the age of 18 undergoing total hip arthroplasty under spinal anesthesia. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesia and Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Jan 2025to 1 Jun 2026
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Voluntary willingness to participate in the study.
  • Patients who will undergo Total Hip Arthroplasty surgery.
  • Patients aged over 18 years.
  • ASA score I-II-III.
  • Patients who are fully oriented and can cooperate.

Who cannot join

  • ASA score IV-V.
  • Patients who refuse to participate in the study.
  • Patients under 18 years of age.
  • Presence of active infection in the area to be operated on.
  • Chronic pain and continuous analgesic use.
  • Patients with coagulation disorders.
Show all 9Show fewer
  • Patients who cannot cooperate with postoperative pain follow-up.
  • Patients with allergies to local anesthetic agents.
  • Presence of neuropathy or myopathy in the operated extremity.

Trial locations and contacts

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

MUZAFFER GENCER contact

+905059436459

aberkaysune@gmail.com

AZİZ BERKAY SÜNE contact

+905012413597

dr.m.gencer07@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Basaksehir Çam Ve Sakura City Hospital

    Istanbul, Türki̇ye

    AZİZ BERKAY SÜNE, +905012413597, aberkaysune@gmail.com

    MUZAFFER GENCER, +905059436459, dr.m.gencer07@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Analgesic Effectiveness Between Pericapsular Nerve Group (PENG) Block and Lumbar Erector Spinae Plane Block in Patients Undergoing Total Hip Arthroplasty With Spinal Anesthesia: a Randomized Controlled Trial

This prospective randomized comparative study aims to compare the analgesic efficacy of pericapsular nerve group block (PENG) and lumbar erector spinae plane block (L-ESP) groups to relieve postoperative pain in participants over the age of 18 undergoing total hip arthroplasty under spinal anesthesia. The main question it aims to answer is:

To demonstrate whether PENG block or L-ESP block is more effective in postoperative analgesia in patients undergoing total hip arthroplasty surgery based on pain scores, opioid consumption, and patient satisfaction.

Total hip arthroplasties cause severe pain with movement in the postoperative period. After surgery, the movements of the participants are severely restricted, which increases the possibility of complications. In this study, the participants' pain status, VAS score, opioid consumption through patient-controlled analgesia, and patient satisfaction will be measured with a questionnaire for 24 hours at predetermined time points and then compared. Both types of blocks have pain-relieving effects. This study will only investigate which one is more effective in reducing pain, and there will be no deficiency in relieving the pain of the participants.

Read the detailed description

Due to increasing life expectancy and the prevalence of obesity, hip arthroplasty surgeries have been steadily increasing, especially in the last twenty years, and these patients experience very serious postoperative pain. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and patient satisfaction. At the same time, optimal pain management is of great importance in contributing to the reduction of the duration of hospital stay, the risk of adverse events such as deep vein thrombosis, and mortality.

Although peripheral nerve blocks have been shown to be effective as part of multimodal analgesia for successful postoperative pain management, the superiority of nerve blocks over each other in terms of analgesic efficacy is a subject of research.

This study was planned to show which of the Pericapsular Nerve Group (PENG) Block and Lumbar Erector Spina Plane Block to be applied to patients undergoing total hip arthroplasty is more effective in terms of postoperative effective analgesia duration, perioperative hemodynamic stability, reducing opioid dependence and postoperative delirium, reducing total opioid consumption, providing early mobilization and shortening the length of hospital stay.

Pericapsular nerve group (PENG) block is a promising regional analgesia procedure that protects the motor function of the hip joint by blocking the obturator nerve, femoral nerve and accessory obturator nerves by injecting local anesthetic between the superior pubic ramus and psoas muscle tendon. Erector spina plane block (ESPB) has been widely used at the thoracic vertebral level in 2016 with ultrasound-guided local anesthetic injection between the erector spinae muscle and the transverse process of the thoracic vertebra. In a single case study published in 2018, lumbar ESPB (L-ESPB) was used as postoperative analgesia after hip arthroplasty, and the local anesthetic injected from the fourth lumbar spine level (L4) spread to the cephalic and caudal directions and provided satisfactory hip analgesia.

Since both blocks are relatively newly defined blocks, there are limited studies in the literature and it is aimed to find an answer to the question of which of these two block types should be preferred by evaluating different parameters in providing postoperative analgesia in hip arthroplasty surgery.

Pericapsular Nerve Group Block (PENG) (Group P) or Lumbar Erector Spina Plane Block (Group E) will be applied preoperatively to patients hospitalized in the orthopedics and traumatology clinic who come to the operating room to undergo Total Hip Arthroplasty Surgery, after the necessary information is provided and monitoring is provided before being taken to the operation with spinal anesthesia. Randomization will be done 1:1 with a computer (using http://www.randomizer.org). Spinal anesthesia will be applied to patients who have preoperative block.

Patient-controlled analgesia (PCA) will be applied to all patients to evaluate opioid consumption at the end of the surgery. The patient's total opioid consumption will be recorded. Pain is a symptom known to be subjective and will be questioned with the Numeric Rating Scale (NRS), a standardized scale, in order to minimize differences between patients. At predetermined time points, Baseline 0, after the block, peroperative 15th minute, 1st hour, 2nd hour and postoperative 1st, 3rd, 6th, 12th, 24th hours, the patients' pain scores with the Numeric Rating Scale (NRS) (0-10; 0-3: mild pain, 4-6: moderate pain, 7-10: severe pain) will be questioned and noted. When the pain score is 4 and above, 20 mg tenoxicam will be administered as rescue analgesia and the total amount required will be recorded.

In both groups, patients' demographic data, ASA scores, surgery duration, hemodynamic parameters during the operation (systolic, diastolic blood pressure, mean arterial pressure, heart rate and SpO2 values), the time when the pain sensation started after the operation, the block termination process in the service follow-ups, the time when the additional analgesics was first needed, the dose administered, the numerical rating scale when the patient was asked to describe the pain intensity numerically, patient satisfaction scores (4: very satisfied, 3: satisfied, 2: less satisfied, 1: not satisfied), hospital stay, nausea-vomiting score and other complications related to the applied blocks will be recorded and followed for the first 24 hours.

Being tested
Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesia, Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesia
Keywords
Pericapsular Nerve Group (PENG) Block, Lumbar Erector Spinae Plane Block, Total Hip Arthroplasty, Postoperative analgesia
Medical subject headings
Pain, Postoperative, Bites and Stings

What participants receive

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

  • Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesiaProcedure or surgery

    Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesia

  • Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesiaProcedure or surgery

    Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesia

Study groups in NCT06821516
Study groupRoleWhat they receive
Participants undergoing total hip arthroplasty with preoperative PENG blockActive comparatorNot described
Receives: Procedure: Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesia
Participants undergoing total hip arthroplasty with preoperative Lumbar ESP blockActive comparatorNot described
Receives: Procedure: Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesia

What is being measured

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

  1. Effectiveness on pain scores

    Postoperative pain assessment is performed using the Numerical Rating Scale (NRS). Participants are asked about their rest pain at Baseline 0, after the block, perioperative 15th minute, 1st hour, 2nd hour, and postoperative 1st, 3rd, 6th, 12th, and 24th hours after applying a postoperative peripheral nerve block. With this method, participants rate their pain with a precise numerical value from 0 to 10. While zero(0) represents "no pain"; Ten (10) represents the opposite end of the pain continuum (e.g., "The most intense pain imaginable," "As intense pain as possible," "Maximum pain").

    Measured: at Baseline 0, after the block, perioperative 15th minute, 1st hour, 2nd hour, and postoperative 1st, 3rd, 6th, 12th, and 24th hours after preoperative peripheral nerve block

Secondary outcomes (6)
  1. Effect on total narcotic analgesic consumption

    After the surgery, patients will be given intravenous patient-controlled analgesia (PCA). "Tramadol" was preferred as the treatment method to be used for the PCA method. In preparation for PCA, 400 mg of tramadol is added to 100 cc of physiological saline. As PCA protocol, without basal infusion dose, 5 cc (20 mg) bolus dose, 20 minutes lockout period (maximum 3 bolus doses in 1 hour) are set. The total number of bolus doses administered by the participants on the PCA device at the end of 24 hours will be recorded and evaluated as the amount of additional opioid needed.

    Measured: The total number of bolus doses administered by the intravenous PCA device at the end of 24 hours postoperatively

  2. Time, frequency, and amount of rescue analgesia administration

    Pain scores (0-10; 0-3: mild pain, 4-6: moderate pain, 7-10: severe pain) will be questioned and noted with the Numerical Rating Scale (NRS). When the pain score is 4 and above, 20 mg tenoxicam will be administered as rescue analgesia and the total amount required will be recorded.

    Measured: first 24 hours postoperatively

  3. Time-dependent perioperative changes in preoperative blood pressure

    Pre-block, post-block, perioperative 0th and 30th minutes, 1st and 2nd hours, and end of surgery blood pressure values will be noted.

    Measured: Pre-block, post-block, perioperative 0th and 30th minutes, 1st and 2nd hours, and end of surgery

  4. Time of first mobilization

    Time of first mobilization will be noted.

    Measured: first 24 hours postoperatively

  5. Length of hospital stay

    Length of hospital stay will be noted.

    Measured: first 24 hours postoperatively

  6. Postoperative nausea and vomiting assessment

    Nausea-vomiting descriptive scale (0: none, 1: mild nausea, 2: nausea, 3: vomiting once, 4: vomiting more than once) will be noted and 0.1 mg/kg IV ondansetron will be administered for scores of 2 and above.

    Measured: first 24 hours postoperatively

Timeline

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

  1. First posted12 Feb 2025
  2. Study start21 Jan 2025
  3. Primary completion1 Mar 2026
  4. Study completion1 Jun 2026 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients who are admitted to the orthopedic and traumatology clinic and are scheduled for total hip arthroplasty surgery will be informed and monitored prior to the operation under spinal anesthesia. Preoperatively, either Pericapsular Nerve Group Block (PENG) (Group P) or Lumbar Erector Spina Plane Block (Group E) will be applied. Randomization will be performed using a computer-based method (http://www.randomizer.org) with a 1:1 allocation.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06821516
Sponsor's protocol ID
BSH-ANES-BS-01
Status last verified
May 2026
First submitted
28 Jan 2025
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

    PubMed 34196965
  • Townsend D, Siddique N, Kimura A, Chein Y, Kamara E, Pope J, Weiser M, Nair S, Muse I. Lumbar Erector Spinae Plane Block for Total Hip Arthroplasty Comparing 24-Hour Opioid Requirements: A Randomized Controlled Study. Anesthesiol Res Pract. 2022 Oct 3;2022:9826638. doi: 10.1155/2022/9826638. eCollection 2022.

    PubMed 36225251
  • Medhat MM, Kamel AAF, Salem DAE, Alagamy SA, Fathi HM. The Analgesic Effects of Preemptive Ultrasound-Guided Pericapsular Nerve Group Block in Comparison with Erector Spinae Plane Block in Elderly Undergoing Hip Arthroplasty: A Randomized Controlled Trial. Anesth Pain Med. 2023 Sep 4;13(5):e138623. doi: 10.5812/aapm-138623. eCollection 2023 Oct.

    PubMed 38028113
  • Marrone F, Fusco P, Tulgar S, Paventi S, Tomei M, Fabbri F, Iacovazzi M, Pullano C. Combination of Pericapsular Nerve Group (PENG) and Sacral Erector Spinae Plane (S-ESP) Blocks for Hip Fracture Pain and Surgery: A Case Series. Cureus. 2024 Feb 7;16(2):e53815. doi: 10.7759/cureus.53815. eCollection 2024 Feb.

    PubMed 38332999
  • Pai P, Amor D, Lai YH, Echevarria GC. Use and Clinical Relevancy of Pericapsular Nerve Block (PENG) in Total Hip Arthroplasty: A Systematic Review and Meta-analysis. Clin J Pain. 2024 May 1;40(5):320-332. doi: 10.1097/AJP.0000000000001196.

    PubMed 38268183
  • Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.

    PubMed 34873023

Questions about this trial

What is this clinical trial studying?

A study testing Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesia and Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesia in people with Opioid Consumption, Postoperative and Pain, Postoperative, run by Başakşehir Çam & Sakura City Hospital 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 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: looking for participants now, as of the sponsor's last update on 7 May 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 MUZAFFER GENCER (+905059436459, aberkaysune@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness on pain scores (time frame: at Baseline 0, after the block, perioperative 15th minute, 1st hour, 2nd hour, and postoperative 1st, 3rd, 6th, 12th, and 24th hours after preoperative peripheral nerve block). 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 NCT06821516, which also lists 6 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 7 May 2026.

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