- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06059339
Comparing Pericapsular Nerve Group Block with Lumbar Erector Spinae Plain Block in Total Hip Arthroplasty Surgery
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Marmara University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- Patients over 18 years old, undergoing total hip arthroplasty surgery
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PENG Block and Spinal Anesthesia
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.
|
Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups
|
|
Active Comparator: Lumbar Erector Spinae Plain Block and Spinal Anesthesia
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.
|
Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups
|
|
Active Comparator: PENG Block and Lumbar Erector Spinae Plain Block and Spinal Anesthesia
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.
|
Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid Consumption
Time Frame: 24 Hours
|
Comparing opioid consumption via Patient Controlled Analgesia (PCA) device 1 mg/ ml morphine, 10 minutes lock out |
24 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Scores
Time Frame: 48 Hours
|
Numeric Rating Scale: (0 to 10: worse pain:10 no pain:0)
|
48 Hours
|
|
rescue analgesia
Time Frame: 48 hours
|
tramadol 1.5 mg/kg if NRS>4.
|
48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01.2023.886
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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