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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hip surgery
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring postoperative pain, nerve block, regional analgesia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Po-Kai Wang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PENG group

QL group

Arm Description

Participants with PENG block

Participants with QL block

Outcomes

Primary Outcome Measures

Comparing pain scores between the PENG and QL groups immediately 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.
Comparing pain scores between the PENG and QL groups 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.
Comparing pain scores between the PENG and QL groups 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.
Comparing pain scores between the PENG and QL groups 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.
Comparing pain scores between the PENG and QL groups 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.

Secondary Outcome Measures

Postoperative opioid consumption
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.
The quadriceps strength on surgical side
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).
Time to independently sit at the edge of the bed after surgery
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.
Time to stand up after surgery
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.
Time to walk with the aid of walking devices after surgery
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.
Perioperative blood loss and blood transfusion
The investigators documented the amount of blood loss and the need for blood transfusion both during the surgery and in the postoperative period.

Full Information

First Posted
May 7, 2023
Last Updated
July 2, 2023
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05932498
Brief Title
Peri-capsular Nerve Group (PENG) Block and Quadratus Lumborum Block for Hip Arthroplasty
Acronym
PENG
Official Title
Peri-capsular Nerve Group Block and Quadratus Lumborum Block for Hip Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
postoperative pain, nerve block, regional analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one group is that participants receive PENG block and another group is that participants receive QL block for postoperative pain control.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants will not know which group they are in. Care provider, investigator, and outcomes assessor does not know which block participants will receive. The anesthesiologists who perform the blocks are not care provider, investigator, or outcomes assessor.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PENG group
Arm Type
Experimental
Arm Description
Participants with PENG block
Arm Title
QL group
Arm Type
Active Comparator
Arm Description
Participants with QL block
Intervention Type
Procedure
Intervention Name(s)
Hip surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparing pain scores between the PENG and QL groups immediately after surgery
Description
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.
Time Frame
10 minutes after surgery
Title
Comparing pain scores between the PENG and QL groups at the 1-hour postoperative mark
Description
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.
Time Frame
at the 1-hour postoperative mark
Title
Comparing pain scores between the PENG and QL groups at the 12-hour postoperative mark
Description
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.
Time Frame
at the 12-hour postoperative mark
Title
Comparing pain scores between the PENG and QL groups at the 24-hour postoperative mark
Description
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.
Time Frame
at the 24-hour postoperative mark
Title
Comparing pain scores between the PENG and QL groups at the 48-hour postoperative mark
Description
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.
Time Frame
at the 48-hour postoperative mark
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
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.
Time Frame
at the 12-, 24-, 48-hours after surgery
Title
The quadriceps strength on surgical side
Description
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).
Time Frame
at the 0-, 1-, 12-, 24-, 48-, and 72-hours after surgery
Title
Time to independently sit at the edge of the bed after surgery
Description
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.
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
Title
Time to stand up after surgery
Description
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.
Time Frame
From the date of hip surgery until the patient achieves standing up, with a maximum follow-up period of 7 days
Title
Time to walk with the aid of walking devices after surgery
Description
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.
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
Title
Perioperative blood loss and blood transfusion
Description
The investigators documented the amount of blood loss and the need for blood transfusion both during the surgery and in the postoperative period.
Time Frame
During the surgery and over the three-day postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Kai Wang, MD, PhD
Organizational Affiliation
Hualien Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Po-Kai Wang
City
Hualien City
State/Province
Hualien
ZIP/Postal Code
97002
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27536639
Citation
Min BW, Kim Y, Cho HM, Park KS, Yoon PW, Nho JH, Kim SM, Lee KJ, Moon KH. Perioperative Pain Management in Total Hip Arthroplasty: Korean Hip Society Guidelines. Hip Pelvis. 2016 Mar;28(1):15-23. doi: 10.5371/hp.2016.28.1.15. Epub 2016 Mar 31.
Results Reference
background
PubMed Identifier
28154824
Citation
Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
Results Reference
background
PubMed Identifier
28036319
Citation
La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
Results Reference
background
PubMed Identifier
30063657
Citation
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
Results Reference
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Peri-capsular Nerve Group (PENG) Block and Quadratus Lumborum Block for Hip Arthroplasty

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