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Completed

NCT Number: NCT05944380

PENG Block for Total Hip Arthroplasty

This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the pericapsular nerve group block on postoperative rehabilitation.

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Key information

Conditions

Hip Osteoarthritis Agnosia Arthritis Hip Arthropathy Hip Disease Hip Pain Chronic Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Osteoarthritis, Hip Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan Univesity of Medical Sciences

Poznan, Wielkopolska, 61-701, Poland

About this study

The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. However, the effect of this block on postoperative rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo before total hip arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients > 18 years old undergoing unilateral total hip arthroplasty

Exclusion criteria

  • refusal to participate
  • < 18 yo
  • Chronic opioid use
  • localized infection

Treatment and study plan

Ropivacaine 0.5% Injectable Solution

Drug

20 mL 0.5% ropivacaine will be injected for the PENG block

Other names: Ropimol

0,9% normal saline

Drug

20 mL 0.9% normal saline will be injected for the PENG block

Other names: placebo

Primary outcomes

  1. postoperative Numeric Pain Rating Scale in motion

    Time frame: Day 2

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  2. postoperative Numeric Pain Rating Scale in motion

    Time frame: Day 3

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  3. postoperative Numeric Pain Rating Scale in motion

    Time frame: Day 4

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

Secondary outcomes

  1. total opioid consumption

    Time frame: 96 hours postoperatively

    milligrams of intravenous morphine equivalents

  2. Time to first opioid

    Time frame: 96 hours postoperatively

    Hours to first administration of an intravenous opioid drug

  3. postoperative Numeric Pain Rating Scale et rest

    Time frame: Day 1

    representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  4. postoperative Numeric Pain Rating Scale et rest

    Time frame: Day 2

    representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  5. postoperative Numeric Pain Rating Scale et rest

    Time frame: Day 3

    representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  6. postoperative Numeric Pain Rating Scale et rest

    Time frame: Day 4

    representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  7. Functional assessment: getting out of bed without help

    Time frame: First day after surgery

    Binary assessment of motor function evaluated at the first day after surgical procedure

  8. Functional assessment: active elevation of the operated limb

    Time frame: First day after surgery

    Binary assessment of motor function evaluated at the first day after surgical procedure

  9. Functional assessment: independent verticalization- by the balcony

    Time frame: First day after surgery

    Binary assessment of motor function evaluated at the first day after surgical procedure

  10. Functional assessment: walking by the balcony

    Time frame: First day after surgery

    Binary assessment of motor function evaluated at the first day after surgical procedure

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Periarticular Nerve Group (PENG) Block for Postoperative Rehabilitation in Total Hip Arthroplasty: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 13, 2023
Registry last updated
Jul 13, 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.

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