Clinical trial NCT05944380: PENG Block for Total Hip Arthroplasty
Official title: Periarticular Nerve Group (PENG) Block for Postoperative Rehabilitation in Total Hip Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Osteoarthritis
Hip Arthropathy
Hip Disease
Hip Pain Chronic
Keywords: periarticular nerve group block
total hip arthroplasty
pain management
multimodal analgesia
regional anesthesia
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old undergoing unilateral total hip arthroplasty

Exclusion Criteria:

* refusal to participate
* \< 18 yo
* Chronic opioid use
* localized infection

Primary outcomes:
measure: postoperative Numeric Pain Rating Scale in motion
timeFrame: Day 2
measure: postoperative Numeric Pain Rating Scale in motion
timeFrame: Day 3
measure: postoperative Numeric Pain Rating Scale in motion
timeFrame: Day 4
Secondary outcomes:
measure: total opioid consumption
timeFrame: 96 hours postoperatively
measure: Time to first opioid
timeFrame: 96 hours postoperatively
measure: postoperative Numeric Pain Rating Scale et rest
timeFrame: Day 1
measure: postoperative Numeric Pain Rating Scale et rest
timeFrame: Day 2
measure: postoperative Numeric Pain Rating Scale et rest
timeFrame: Day 3
measure: postoperative Numeric Pain Rating Scale et rest
timeFrame: Day 4
measure: Functional assessment: getting out of bed without help
timeFrame: First day after surgery
measure: Functional assessment: active elevation of the operated limb
timeFrame: First day after surgery
measure: Functional assessment: independent verticalization- by the balcony
timeFrame: First day after surgery
measure: Functional assessment: walking by the balcony
timeFrame: First day after surgery
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan Univesity of Medical Sciences
state: Wielkopolska
Study officials:
affiliation: Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland
name: Małgorzata Domagalska, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Emergency Medicine Clinic
name: Zbigniew Żaba, PhD
role: STUDY_CHAIR
References: