Postoperative PainNCT06059339
Comparing Pericapsular Nerve Group Block with Lumbar Erector Spinae Plain Block in Total Hip Arthroplasty Surgery
A study testing Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups in people with Postoperative Pain and Total Hip Arthroplasty, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Pain, Total Hip Arthroplasty
- What is being tested?
- Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2023to 31 Jul 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old, undergoing total hip arthroplasty surgery
Who cannot join
- Patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Postoperative Opioid Consumption of Pericapsular Nerve Group (PENG) Block with Lumbar Erector Spinae Plain Block in Total Hip Arthroplasty Surgery
Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty.
Beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity .
The primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (PENG) block with lumbar erector spinae plain block.
Read the detailed description
Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty.
Beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity .
The primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (PENG) block with lumbar erector spinae plain block.
- Conditions
- Postoperative Pain, Total Hip Arthroplasty
- Being tested
- Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups
- Keywords
- Total Hip Arthroplasty, PENG Block, Lumbar Erector Spinae Plain Block, Postoperative Opioid Consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groupsOther
Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups
| Study group | Role | What they receive |
|---|---|---|
| PENG Block and Spinal Anesthesia | Active comparator | The patients receive PENG block with 20 ml 0,25% bupivacaine for postoperative pain management at the beginning of the surgery. Before the block performance, patients received spinal anesthesia at the L3-L4 level with 20 mg heavy bupivacaine. All patients will receive the same postoperative multimodal analgesia regimen, which includes intravenous paracetamol 1000 mg every 6 hours and intramuscular diclofenac 75 mg every 12 hours. In addition, intravenous patient-controlled analgesia (PCA) with morphine will be administered for 48 hours postoperatively, with a bolus dose of 1 mg and a lockout interval of 10 minutes (no basal rate). If the Numeric Rating Scale (NRS) exceeds 4, intravenous tramadol (1.5 mg/kg) will be administered as rescue analgesia. Receives: Other: Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups |
| Lumbar Erector Spinae Plain Block and Spinal Anesthesia | Active comparator | The patients receive LESP block for postoperative pain management at the beginning of the surgery. The LESP block will be provided with 40 ml 0,25% bupivacaine under ultrasonography. Following the block performance, patients received spinal anesthesia at the L3-L4 level with 20 mg heavy bupivacaine. All patients will receive the same postoperative multimodal analgesia regimen, which includes intravenous paracetamol 1000 mg every 6 hours and intramuscular diclofenac 75 mg every 12 hours. In addition, intravenous patient-controlled analgesia (PCA) with morphine will be administered for 48 hours postoperatively, with a bolus dose of 1 mg and a lockout interval of 10 minutes (no basal rate). If the Numeric Rating Scale (NRS) exceeds 4, intravenous tramadol (1.5 mg/kg) will be administered as rescue analgesia. Receives: Other: Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups |
| PENG Block and Lumbar Erector Spinae Plain Block and Spinal Anesthesia | Active comparator | The patients receive LESP block and PENG block for postoperative pain management at the beginning of the surgery. The LESP block (40 ml) and PENG block (20 ml) will be provided with 0,25% bupivacaine each under ultrasonography. Patients receive spinal anesthesia at the L3-L4 level with 20 mg heavy bupivacaine. All patients will receive the same postoperative multimodal analgesia regimen, which includes intravenous paracetamol 1000 mg every 6 hours and intramuscular diclofenac 75 mg every 12 hours. In addition, intravenous patient-controlled analgesia (PCA) with morphine will be administered for 48 hours postoperatively, with a bolus dose of 1 mg and a lockout interval of 10 minutes (no basal rate). If the Numeric Rating Scale (NRS) exceeds 4, intravenous tramadol (1.5 mg/kg) will be administered as rescue analgesia. Receives: Other: Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Comparing opioid consumption via Patient Controlled Analgesia (PCA) device
1 mg/ ml morphine, 10 minutes lock out
Measured: 24 Hours
Secondary outcomes (2)
Pain Scores
Numeric Rating Scale: (0 to 10: worse pain:10 no pain:0)
Measured: 48 Hours
rescue analgesia
tramadol 1.5 mg/kg if NRS>4.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start22 Apr 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beliz Bilgili, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059339
- Sponsor's protocol ID
- 01.2023.886
- Status last verified
- Jul 2024
- First submitted
- 4 Apr 2023
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Postoperative Opioid Consumption of Pericapsular Nerve Group (PENG) Block with Lumbar Erector Spinae Plain Block in Total Hip Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT06059339
- Acronym / sponsor ID
- 01.2023.886
- Conditions
- Postoperative Pain, Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty, PENG Block, Lumbar Erector Spinae Plain Block, Postoperative Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Sep 2023 (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.
Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty.
Beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity .
The primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (PENG) block with lumbar erector spinae plain block.
Detailed description
Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty.
Beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity .
The primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (PENG) block with lumbar erector spinae plain block.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PENG Block and Spinal Anesthesia | Active comparator | Other: Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groupsThe patients receive PENG block with 20 ml 0,25% bupivacaine for postoperative pain management at the beginning of the surgery. Before the block performance, patients received spinal anesthesia at the L3-L4 level with 20 mg heavy bupivacaine. All patients will receive the same postoperative multimodal analgesia regimen, which includes intravenous paracetamol 1000 mg every 6 hours and intramuscular diclofenac 75 mg every 12 hours. In addition, intravenous patient-controlled analgesia (PCA) with morphine will be administered for 48 hours postoperatively, with a bolus dose of 1 mg and a lockout interval of 10 minutes (no basal rate). If the Numeric Rating Scale (NRS) exceeds 4, intravenous tramadol (1.5 mg/kg) will be administered as rescue analgesia. |
| Lumbar Erector Spinae Plain Block and Spinal Anesthesia | Active comparator | Other: Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groupsThe patients receive LESP block for postoperative pain management at the beginning of the surgery. The LESP block will be provided with 40 ml 0,25% bupivacaine under ultrasonography. Following the block performance, patients received spinal anesthesia at the L3-L4 level with 20 mg heavy bupivacaine. All patients will receive the same postoperative multimodal analgesia regimen, which includes intravenous paracetamol 1000 mg every 6 hours and intramuscular diclofenac 75 mg every 12 hours. In addition, intravenous patient-controlled analgesia (PCA) with morphine will be administered for 48 hours postoperatively, with a bolus dose of 1 mg and a lockout interval of 10 minutes (no basal rate). If the Numeric Rating Scale (NRS) exceeds 4, intravenous tramadol (1.5 mg/kg) will be administered as rescue analgesia. |
| PENG Block and Lumbar Erector Spinae Plain Block and Spinal Anesthesia | Active comparator | Other: Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groupsThe patients receive LESP block and PENG block for postoperative pain management at the beginning of the surgery. The LESP block (40 ml) and PENG block (20 ml) will be provided with 0,25% bupivacaine each under ultrasonography. Patients receive spinal anesthesia at the L3-L4 level with 20 mg heavy bupivacaine. All patients will receive the same postoperative multimodal analgesia regimen, which includes intravenous paracetamol 1000 mg every 6 hours and intramuscular diclofenac 75 mg every 12 hours. In addition, intravenous patient-controlled analgesia (PCA) with morphine will be administered for 48 hours postoperatively, with a bolus dose of 1 mg and a lockout interval of 10 minutes (no basal rate). If the Numeric Rating Scale (NRS) exceeds 4, intravenous tramadol (1.5 mg/kg) will be administered as rescue analgesia. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old, undergoing total hip arthroplasty surgery
Key exclusion criteria (1 listed)
- Patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.
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 |
|---|---|---|
| Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groupsProcedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups | Other | Lumbar Erector Spinae Plain Block and Spinal Anesthesia, PENG Block and Lumbar Erector Spinae Plain Block and Spinal Anesthesia, PENG Block and Spinal Anesthesia |
Primary outcome
Opioid Consumption
Time frame: 24 Hours
Comparing opioid consumption via Patient Controlled Analgesia (PCA) device 1 mg/ ml morphine, 10 minutes lock out
2 secondary outcomes
Pain Scores
Time frame: 48 Hours
rescue analgesia
Time frame: 48 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 10 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups in people with Postoperative Pain and Total Hip Arthroplasty, run by Marmara 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 1 inclusion and 1 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 10 Jan 2025. 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?
Opioid Consumption (time frame: 24 Hours). 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 10 Jan 2025.