NCT05932498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

May 7, 2023

Last Update Submit

July 2, 2023

Conditions

Keywords

postoperative painnerve blockregional analgesia

Outcome Measures

Primary Outcomes (5)

  • 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.

    10 minutes after surgery

  • 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.

    at the 1-hour postoperative mark

  • 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.

    at the 12-hour postoperative mark

  • 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.

    at the 24-hour postoperative mark

  • 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.

    at the 48-hour postoperative mark

Secondary Outcomes (6)

  • Postoperative opioid consumption

    at the 12-, 24-, 48-hours after surgery

  • The quadriceps strength on surgical side

    at the 0-, 1-, 12-, 24-, 48-, and 72-hours after surgery

  • Time to independently sit at the edge of the bed after 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

    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

    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

  • +1 more secondary outcomes

Study Arms (2)

PENG group

EXPERIMENTAL

Participants with PENG block

Procedure: Hip surgery

QL group

ACTIVE COMPARATOR

Participants with QL block

Procedure: Hip surgery

Interventions

Hip surgeryPROCEDURE

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.

PENG groupQL group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Po-Kai Wang

Hualien City, Hualien, 97002, Taiwan

Location

Related Publications (4)

  • 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.

    PMID: 27536639BACKGROUND
  • 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.

    PMID: 28154824BACKGROUND
  • 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.

    PMID: 28036319BACKGROUND
  • 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.

    PMID: 30063657BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Po-Kai Wang, MD, PhD

    Hualien Tzu Chi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: one group is that participants receive PENG block and another group is that participants receive QL block for postoperative pain control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Pain Management, Department of Anesthesiology

Study Record Dates

First Submitted

May 7, 2023

First Posted

July 6, 2023

Study Start

January 6, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations