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Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty

Primary Purpose

Hip Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group A
Group B
Group C
Sponsored by
Karaman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthropathy focused on measuring PENG block, intra-artikuler, Quadrotus lumborum block, Hip Arthropathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physical status according to American Society of Anesthesiologists (ASA ) I-III

Exclusion Criteria:

  • Previous operation on the same hip
  • Hepatic or renal insufficiency
  • Younger than 18 years old and older than 85
  • Patients undergoing general anesthesia
  • Allergy or intolerance to one of the study medications
  • BMI >40
  • ASA IV
  • Chronic gabapentin/pregabalin use ( regular use for longer than 3 months)
  • Chronic opioid use ( taking opioids for longer than 3 months, or daily oral morphine equivalent of >5 mg/day one month

Sites / Locations

  • Tayfun Et

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

PENG BLOCK ( Group A)

Intra-articular( Group B)

Quadratus lumborum block ( Group C)

Arm Description

A regional block will be applied while the patient is in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) will initially be placed in a transverse plane on the AIIS and then rotate the probe approximately 45 degrees counterclockwise to align with the pubic ramus. In this view, IPE, iliopsoas muscle and tendon, femoral artery and pectineus muscle will be observed. A 22 gauge, 80 mm needle will be inserted from lateral to medial in an in-plane approach to place the psoas tendon anteriorly and posteriorly in the musculofacial plane between the pubic ramus. Following negative aspiration, a local anesthetic solution (20ml bupivacaine 0.5%) will be injected.

It will be applied to the intra-articular region by the surgeon at the end of the operation. A volume of 60 ml (30 ml of 0.5% bupivacaine and 30 ml of 0.9% NaCl)

The patient will be in the lateral position. A low-frequency convex probe will be vertically attached above the iliac crest and a needle will be inserted in-plane from the posterior edge of the convex probe through the quadratus lumborum in an anteromedial direction. The needle tip will be placed between the psoas major muscle and the quadratus lumborum muscle. After negative aspiration, 30 mL of 0.5 % of bupivacaine will be injected into the fascial plane incrementally, aspirating every 5 ml.

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS) scores
Range 0-10, 0=no pain, 10=the worse pain ever

Secondary Outcome Measures

Opioid consumption
Analgesic consumption
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) 0 = no pain and 10 = worst imaginable painranged from 0 to 10
Presence of quadriceps motor block (defined as paralysis or paresis )
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Hip adduction strength
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depressio
Patient satisfaction
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Quality of Recovery (QoR-40) score
QoR-40, a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.
Mobilization time
Mobilization time

Full Information

First Posted
August 3, 2021
Last Updated
January 28, 2023
Sponsor
Karaman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05003544
Brief Title
Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty
Official Title
Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty: : Randomized Controlled Double Blinded Trial Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karaman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
90 patients ASA I-III, undergoing Total hip arthroplasty (THA) under spinal anesthesia, will be randomly assigned into one of three groups, namely group A (n=30), where an PENG block, group B (N:30) where an inra-articuler, and group C (n=30) where Quadratus lumborum block will be performed preoperatively. All patients will receive a standardized postoperative analgesia regimen. NRS scores will be evaluated in static and dynamic conditions during the first 48 hours postoperatively.
Detailed Description
Total hip arthroplasty (THA) is the second most common joint replacement surgery, partly due to the aging population. The primary aim of this study is to compare the analgesic efficacy of Pericapsular nerve group (PENG) block with intra-articular and Quadrotus lumborum block (QLB). Regional anesthesia (RA), such as the recently described pericapsular nerve group (PENG) block, may provide additional analgesic benefit in this situation. Pericapsular nerve group (PENG) block is a new regional anesthesia technique to provide analgesia after hip fractures and hip arthroplasty. The aim of this single-center, double-blind, randomized controlled trial is to confirm the efficacy of PENG block for postoperative recovery after primary THA. Routine multimodal analgesia will be used for postoperative analgesia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy
Keywords
PENG block, intra-artikuler, Quadrotus lumborum block, Hip Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PENG BLOCK ( Group A)
Arm Type
Active Comparator
Arm Description
A regional block will be applied while the patient is in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) will initially be placed in a transverse plane on the AIIS and then rotate the probe approximately 45 degrees counterclockwise to align with the pubic ramus. In this view, IPE, iliopsoas muscle and tendon, femoral artery and pectineus muscle will be observed. A 22 gauge, 80 mm needle will be inserted from lateral to medial in an in-plane approach to place the psoas tendon anteriorly and posteriorly in the musculofacial plane between the pubic ramus. Following negative aspiration, a local anesthetic solution (20ml bupivacaine 0.5%) will be injected.
Arm Title
Intra-articular( Group B)
Arm Type
Active Comparator
Arm Description
It will be applied to the intra-articular region by the surgeon at the end of the operation. A volume of 60 ml (30 ml of 0.5% bupivacaine and 30 ml of 0.9% NaCl)
Arm Title
Quadratus lumborum block ( Group C)
Arm Type
Active Comparator
Arm Description
The patient will be in the lateral position. A low-frequency convex probe will be vertically attached above the iliac crest and a needle will be inserted in-plane from the posterior edge of the convex probe through the quadratus lumborum in an anteromedial direction. The needle tip will be placed between the psoas major muscle and the quadratus lumborum muscle. After negative aspiration, 30 mL of 0.5 % of bupivacaine will be injected into the fascial plane incrementally, aspirating every 5 ml.
Intervention Type
Procedure
Intervention Name(s)
Group A
Intervention Description
PENG BLOCK
Intervention Type
Procedure
Intervention Name(s)
Group B
Intervention Description
Intra-articular
Intervention Type
Procedure
Intervention Name(s)
Group C
Intervention Description
Quadratus lumborum block
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) scores
Description
Range 0-10, 0=no pain, 10=the worse pain ever
Time Frame
48 Hours
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
Analgesic consumption
Time Frame
3-6-8-12-24 and 48 hours
Title
Static and dynamic pain
Description
Pain intensity at rest and during active movement using a numeric rating score (NRS) 0 = no pain and 10 = worst imaginable painranged from 0 to 10
Time Frame
3-6-8-12-24 and 48 hours
Title
Presence of quadriceps motor block (defined as paralysis or paresis )
Description
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Time Frame
3-6-12-24 hours after the block
Title
Hip adduction strength
Description
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively
Time Frame
3-6-12-24 hours after the block
Title
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Description
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depressio
Time Frame
3-6-12-24 hours after the block
Title
Patient satisfaction
Description
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Time Frame
48 hours
Title
Quality of Recovery (QoR-40) score
Description
QoR-40, a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.
Time Frame
measurements are obtained at 24 hours, 48 hours, and one week
Title
Mobilization time
Description
Mobilization time
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physical status according to American Society of Anesthesiologists (ASA ) I-III Exclusion Criteria: Previous operation on the same hip Hepatic or renal insufficiency Younger than 18 years old and older than 85 Patients undergoing general anesthesia Allergy or intolerance to one of the study medications BMI >40 ASA IV Chronic gabapentin/pregabalin use ( regular use for longer than 3 months) Chronic opioid use ( taking opioids for longer than 3 months, or daily oral morphine equivalent of >5 mg/day one month
Facility Information:
Facility Name
Tayfun Et
City
Karaman
ZIP/Postal Code
70200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30386022
Citation
Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
Results Reference
background

Learn more about this trial

Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty

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