Peri-capsular Nerve Group (PENG) Block and Quadratus Lumborum Block for Hip Arthroplasty (PENG)

July 2, 2023 updated by: Po-Kai Wang, Buddhist Tzu Chi General Hospital

Peri-capsular Nerve Group Block and Quadratus Lumborum Block for Hip Arthroplasty: A Randomized Controlled Trial

The goal of this randomized controlled clinical trial is to compare peri-capsular nerve group (PENG) block and quadratus lumborum (QL) block in participants who receive hip arthroplasty. The main question aims to answer is comparing the pain score among participants who receive PENG or QL block.

Participants will be randomized and assigned into two groups. Participants will receive a PENG block in the PENG group and receive a QL block in the QL group. After participants receive hip arthroplasty, the investigators will compare the two groups to see if there is a difference of pain score, postoperative opioid consumption, sensation and motor function after nerve blocks, progress of functional recovery in lower limbs, intraoperative and postoperative complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hip joint surgery is a common orthopedic procedure that effectively improves patients' quality of life and functional status. However, postoperative pain is a common issue that can affect patients' activity, increase the risk of venous thromboembolism due to venous stasis, and prolong recovery time, hospital stay, and expenses. Therefore, controlling postoperative pain after hip joint surgery is crucial to reduce its side effects. Nerve block is one of the methods for postoperative pain management after hip joint surgery and has been proven effective in reducing pain levels, decreasing opioid use, and its side effects.

Traditionally, the quadratus lumborum nerve block (QL block) is used for pain relief during abdominal surgery, but it can also be used for lower limb surgery due to its extensive application. Compared to other nerve blocks, QL block may provide better postoperative pain relief, have less impact on hip joint activity and quadriceps muscle contraction, and reduce opioid use and hospital stay.

The peri-capsular nerve group block (PENG block) is another nerve block technique performed by injecting anesthetic analgesics around the hip joint capsule using ultrasound and blocking surrounding nerves with a larger dose. In a clinical study, PENG block significantly reduced static and dynamic pain scores in five patients with femoral neck fractures after 30 minutes of the nerve block. PENG block has advantages in injection and identification of anatomical structures compared to QL block, but their analgesic effects have not been directly compared. Therefore, clinical trials of both techniques are needed.

Study Type

Interventional

Enrollment (Actual)

50

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

    • Hualien
      • Hualien City, Hualien, Taiwan, 97002
        • Po-Kai Wang

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

Yes

Description

Inclusion Criteria:

  • Patients who are 20 years of age or older (including 20 years of age).
  • Non-emergency hip arthroplasty surgery.
  • Able to understand and cooperate with preoperative and postoperative data collection.
  • Grade one to three in the American Society of Anesthesiologists (ASA) physical status classification.

Exclusion Criteria:

  • Under 20 years of age.
  • A known allergy to the study medication (ropivacaine).
  • Liver cirrhosis classified as Child Pugh Score C.
  • Dementia or mental illness.
  • Unable to assess their own pain level.
  • Patients who have been using opioid drugs for a prolonged period.
  • Having a history of drug or alcohol abuse within the last 6 months.
  • Having serious illness and at a risk of imminent mortality.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PENG group
Participants with PENG block

Ultrasound-guided PENG block was administered to patients undergoing hip surgery intraoperatively.

OR

Ultrasound-guided QL block was administered to patients undergoing hip surgery intraoperatively.

Active Comparator: QL group
Participants with QL block

Ultrasound-guided PENG block was administered to patients undergoing hip surgery intraoperatively.

OR

Ultrasound-guided QL block was administered to patients undergoing hip surgery intraoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing pain scores between the PENG and QL groups immediately after surgery
Time Frame: 10 minutes after surgery
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
10 minutes after surgery
Comparing pain scores between the PENG and QL groups at the 1-hour postoperative mark
Time Frame: at the 1-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
at the 1-hour postoperative mark
Comparing pain scores between the PENG and QL groups at the 12-hour postoperative mark
Time Frame: at the 12-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
at the 12-hour postoperative mark
Comparing pain scores between the PENG and QL groups at the 24-hour postoperative mark
Time Frame: at the 24-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
at the 24-hour postoperative mark
Comparing pain scores between the PENG and QL groups at the 48-hour postoperative mark
Time Frame: at the 48-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
at the 48-hour postoperative mark

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: at the 12-, 24-, 48-hours after surgery
Comparing the amount of parenteral opioids administered for rescue purposes as Morphine Milligram Equivalents (MME) between the PENG and QL groups at various postoperative time intervals.
at the 12-, 24-, 48-hours after surgery
The quadriceps strength on surgical side
Time Frame: at the 0-, 1-, 12-, 24-, 48-, and 72-hours after surgery
After performing PENG or QL blocks, the investigators assessed and compared the strength of the quadriceps muscles on the side that underwent hip surgery using Manual Muscle Testing (MMT) scores. MMT involves assigning scores to assess the patients' quadriceps muscle strength, ranging from 0 (no activation) to 5 (activation against resistance).
at the 0-, 1-, 12-, 24-, 48-, and 72-hours after surgery
Time to independently sit at the edge of the bed after surgery
Time Frame: From the date of hip surgery until the patient achieves independent sitting at the edge of the bed, with a maximum follow-up period of 7 days

Sitting at the edge of the bed is a functional milestone that reflects the patient's progress toward regaining mobility and independence in activities of daily living.

The duration required to achieve sitting at the edge of the bed was measured in terms of the number of days following the surgery.

From the date of hip surgery until the patient achieves independent sitting at the edge of the bed, with a maximum follow-up period of 7 days
Time to stand up after surgery
Time Frame: From the date of hip surgery until the patient achieves standing up, with a maximum follow-up period of 7 days

Standing up indicates the patient's ability to bear weight on the affected hip joint and engage in activities such as walking, transferring, and performing daily tasks after hip surgery.

The duration required to achieve standing up was measured in terms of the number of days following the surgery.

From the date of hip surgery until the patient achieves standing up, with a maximum follow-up period of 7 days
Time to walk with the aid of walking devices after surgery
Time Frame: From the date of hip surgery until the patient achieves walking with the aid of walking devices, with a maximum follow-up period of 7 days

Walking with the aid of walking devices reflects the patient's ability to regain mobility and independence in walking, even if patients require assistance or support from these devices.

The duration required to achieve walking with the aid of walking devices was measured in terms of the number of days following the surgery.

From the date of hip surgery until the patient achieves walking with the aid of walking devices, with a maximum follow-up period of 7 days
Perioperative blood loss and blood transfusion
Time Frame: During the surgery and over the three-day postoperative period
The investigators documented the amount of blood loss and the need for blood transfusion both during the surgery and in the postoperative period.
During the surgery and over the three-day postoperative period

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Po-Kai Wang, MD, PhD, Hualien Tzu Chi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

January 6, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

May 7, 2023

First Submitted That Met QC Criteria

July 2, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 2, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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