Skip to main content
OpenTrials
Completed

NCT Number: NCT05003544

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Arthropathy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tayfun Et

Karaman, 70200, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group A

Procedure

PENG BLOCK

Group B

Procedure

Intra-articular

group C

Procedure

Quadratus lumborum block

Primary outcomes

  1. Numerical Rating Scale (NRS) scores

    Time frame: 48 Hours

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

Secondary outcomes

  1. Opioid consumption

    Time frame: 3-6-8-12-24 and 48 hours

    Analgesic consumption

  2. Static and dynamic pain

    Time frame: 3-6-8-12-24 and 48 hours

    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

  3. Presence of quadriceps motor block (defined as paralysis or paresis )

    Time frame: 3-6-12-24 hours after the block

    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).

  4. Hip adduction strength

    Time frame: 3-6-12-24 hours after the block

    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

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

    Time frame: 3-6-12-24 hours after the block

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

  6. Patient satisfaction

    Time frame: 48 hours

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

  7. Quality of Recovery (QoR-40) score

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

    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.

  8. Mobilization time

    Time frame: 24 hour

    Mobilization time

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2021
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.