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

NCT06059339 | Completed

• 1 other identifier: 01.2023.886
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Total Hip Arthroplasty; PENG Block; Lumbar Erector Spinae Plain Block; Postoperative Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Comparing opioid consumption via Patient Controlled Analgesia (PCA) device 1 mg/ ml morphine, 10 minutes lock out

  24 Hours

Secondary Outcomes (2)

• Pain Scores

  48 Hours

• rescue analgesia

  48 hours

Study Arms (3)

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.

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.

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.

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

Interventions

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

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

Lumbar Erector Spinae Plain Block and Spinal Anesthesia; PENG Block and Lumbar Erector Spinae Plain Block and Spinal Anesthesia; PENG Block and Spinal Anesthesia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old, undergoing total hip arthroplasty surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: September 28, 2023
• Study Start: April 22, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 10, 2025

Record last verified: 2024-07

Locations

TU (1)