Comparing Pericapsular Nerve Group Block with Lumbar Erector Spinae Plain Block in Total Hip Arthroplasty Surgery

NCT ID: NCT06059339

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-22

Study Completion Date

2024-07-31

Brief Summary

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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

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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

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Postoperative Pain Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups

Intervention Type OTHER

Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups

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.

Group Type ACTIVE_COMPARATOR

Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups

Intervention Type OTHER

Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups

Interventions

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Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups

Procedure/Surgery: Regional Block Comparison Comparing postoperative pain and opioid consumption in groups

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Beliz Bilgili

Associated Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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01.2023.886

Identifier Type: -

Identifier Source: org_study_id

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