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

April 19, 2024 updated by: Beliz Bilgili, Marmara University

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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Patients over 18 years old, undergoing hip fracture surgery in our university hospital

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 for postoperative pain management at the beginning of the surgery. TheLESP block will be provided with 20 ml 0,025% bupivacain under ultrasonography.
Other: 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
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. TheLESP block will be provided with 20 ml 0,025% bupivacain under ultrasonography.
Other: 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
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 and PENG block will be provided with 20 ml 0,025% bupivacain each under ultrasonography.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores
Time Frame: 48 Hours
Comparing pain scores with Numeric Rating Scale (NRS)
48 Hours
Opioid Consumption
Time Frame: 48 Hours
Comparing opioid consumption via Patient Controlled Analgesia (PCA) device
48 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Mobilization
Time Frame: 7 Days
the time between the surgery to mobilization of the patient
7 Days
Patient Satisfaction
Time Frame: 48 Hours
Patient Satisfaction score- 0 to 5: unsatisfied:0 satisfied:5
48 Hours
Complications Related to Pain Management
Time Frame: 48 Hours
Complications Related to Pain Management- nausea, vomiting, itching
48 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Estimated)

April 22, 2024

Study Completion (Estimated)

May 22, 2024

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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