Actively Recruiting
The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthroplasty: a Prospective, Double-blinded, Randomized Controlled Trial
Led by Diakonie-Klinikum Stuttgart · Updated on 2024-08-16
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Diakonie-Klinikum Stuttgart
Lead Sponsor
U
University Hospital Tuebingen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the pain-relieving effects of the pericapsular nerve group (PENG) block during hip replacement surgery. This prospective, randomized, double-blind study compares two groups of patients undergoing primary total hip arthroplasty. Participants are assigned to receive either 20 ml of ropivacaine 0.5% or 20 ml of a saline solution as a placebo to assess the impact on postoperative pain management. The study involves two treatment groups: one receiving the PENG block with ropivacaine, a local anesthetic, and the other receiving a placebo injection of physiological saline. Both treatments are administered during the hip implant procedure, which uses a minimally invasive anterolateral approach with a specific implant system. The trial is designed to maintain blinding and randomization to fairly compare the effects. Participants will be monitored for opioid use within the first hour after recovery room arrival, along with total opioid consumption, pain levels, nausea, vomiting, and overall recovery until the evening of the second day after surgery. The study tracks these outcomes closely to understand the efficacy of the PENG block. The total duration of involvement includes the surgical procedure and postoperative observation up to two days after surgery.
CONDITIONS
Brief Title
The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty:
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned cementless hip total endoprosthesis operation for primary osteoarthritis using a minimally invasive anterolateral approach with the identical implant system (Taperloc stem, Plamafit cup)
- Patient capable of giving consent
- Informed consent has been obtained
- Age over 18 years
You will not qualify if you...
- Refusal to participate in the study
- Regular use of opioids
- Known chronic pain symptoms
- Infections in the area of the puncture site
- Contraindication to ropivacaine
- Contraindication to metamizole
- Contraindication to postoperative analgesia with diclofenac
- Secondary osteoarthritis with deformities such as high-grade dysplasia, trauma-related conditions, or childhood hip diseases
- Spinopelvic imbalance or spinal canal stenosis
- Previous operations on the hip or pelvis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 days until the evening of the second postoperative day
Participants receive either the PENG block with ropivacaine or a placebo control during their hip arthroplasty surgery.
1 surgery visit and daily assessments until the evening of the second postoperative day
Trial Site Locations
Total: 1 location
1
Diakonie-Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, Germany, 70176
Actively Recruiting
Research Team
R
Rainer Meierhenrich, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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