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Hip ArthropathyNCT05003544

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

A study testing Group A, Group B and Group C in people with Hip Arthropathy, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Hip Arthropathy
What is being tested?
Group A, Group B and Group C
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Aug 2021to 20 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Tayfun Et

    Karaman, 70200

Other trials in Turkey (Türkiye)

About this study

Official title: Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty: : Randomized Controlled Double Blinded Trial Trial

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.

Read the 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

Conditions
Hip Arthropathy
Being tested
Group A, Group B, Group C
Keywords
PENG block, intra-artikuler, Quadrotus lumborum block, Hip Arthropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group AProcedure or surgery

    PENG BLOCK

  • Group BProcedure or surgery

    Intra-articular

  • Group CProcedure or surgery

    Quadratus lumborum block

Study groups in NCT05003544
Study groupRoleWhat they receive
PENG BLOCK ( Group A)Active comparatorA 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.
Receives: Procedure: Group A
Intra-articular( Group B)Active comparatorIt 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)
Receives: Procedure: Group B
Quadratus lumborum block ( Group C)Active comparatorThe 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.
Receives: Procedure: Group C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numerical Rating Scale (NRS) scores

    Range 0-10, 0=no pain, 10=the worse pain ever

    Measured: 48 Hours

Secondary outcomes (8)

  1. Opioid consumption

    Analgesic consumption

    Measured: 3-6-8-12-24 and 48 hours

  2. 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

    Measured: 3-6-8-12-24 and 48 hours

  3. 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).

    Measured: 3-6-12-24 hours after the block

  4. 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

    Measured: 3-6-12-24 hours after the block

  5. Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression

    Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depressio

    Measured: 3-6-12-24 hours after the block

  6. Patient satisfaction

    Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No

    Measured: 48 hours

  7. 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.

    Measured: measurements are obtained at 24 hours, 48 hours, and one week

  8. Mobilization time

    Mobilization time

    Measured: 24 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start25 Aug 2021
  3. Primary completion8 Dec 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003544
Sponsor's protocol ID
04-2021/14
Status last verified
Sep 2022
First submitted
3 Aug 2021
Last updated
31 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30386022

Questions about this trial

What is this clinical trial studying?

A study testing Group A, Group B and Group C in people with Hip Arthropathy, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numerical Rating Scale (NRS) scores (time frame: 48 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05003544, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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