ProspectivePENGNCT06557044
The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty:
A study testing Ropivacaine and Physiological saline in people with Prospective and Randomized, run by Diakonie-Klinikum Stuttgart at 1 site in Germany.
Trial summary
The aim of this study is to investigate the analgesic efficacy of the pericapsular nerve group (PENG) block during the implantation of hip endoprostheses. The study is designed as a prospective randomized double-blind study and the study participants were randomized into 2 arms and either 20 ml ropivacaine 0.5% (verum… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prospective, Randomized, Double-blind
- What is being tested?
- Ropivacaine and Physiological saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 7 Mar 2024to Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned cementless hip TEP operation for primary coxarthrosis via minimally invasive anterolateral approach using the identical implant system (Taperloc stem, Plamafit cup)
- Patient capable of giving consent
- Informed consent has been obtained
- age > 18 years
Who cannot join
- Refusal to participate in the study
- Regular use of opioids
- Known chronic pain symptoms
- Infections in the area of the puncture site
- Presence of a contraindication to ropivacaine
- Presence of a contraindication to metamizole
Show all 10Show fewer
- Presence of a contraindication to postoperative analgesia with diclofenac
- Secondary forms of osteoarthritis with deformities (i.e. high-grade dysplasia, secondary conditions after trauma, secondary conditions after childtrauma, secondary conditions after childhood hip joint diseases
- Spinopelvic dysbalance, spinal canal stenosis
- Previous operations on the hip/pelvis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Diakonie-Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, 70176
Rainer Meierhenrich, Prof. Dr., 00497119912290, meierhenrich@diak-stuttgart.de
About this study
Official title: The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty: a Prospective, Double-blinded, Randomized Controlled Trial
The aim of this study is to investigate the analgesic efficacy of the pericapsular nerve group (PENG) block during the implantation of hip endoprostheses. The study is designed as a prospective randomized double-blind study and the study participants were randomized into 2 arms and either 20 ml ropivacaine 0.5% (verum group) or 20 ml physiological saline solution (placebo group) will be applied.
- Conditions
- Prospective, Randomized, Double-blind
- Being tested
- Ropivacaine, Physiological saline
- Keywords
- Pericapsular Nerve Group Block, hip endoprostheses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
PENG block with ropivacaine
Physiological salineOther
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| Verum Group | Experimental | 20 ml ropivacaine 0.5% Receives: Drug: Ropivacaine |
| Placebo Group | Placebo comparator | 20 ml physiological saline Receives: Other: Physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative opioid administration
The primary objective is to investigate the influence of the PENG block on the need for postoperative ntravenously opioid administration within the first hour in the recovery room.
Measured: 60 minutes after arrival in the recovery room
Secondary outcomes (4)
Quantity of total opioid consumption
Assessment of total opioid consumption until second postoperative day in both arms
Measured: until the evening of the second postoperative day
Intensity of postoperative pain
Subjective perception of postoperative pain, using the numeric rating scale.
Measured: until the evening of the second postoperative day
Intensity of postoperative nausea and vomiting
Assessment of postoperative nausea/vomiting using the PONV Score
Measured: until the evening of the second postoperative day
Postoperative recovery
Assessment of postoperative recovery using the QoR15 score
Measured: until the evening of the second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start7 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProspectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonie-Klinikum Stuttgart
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Principal investigator, Prof. Dr. Rainer Meierhernich, Diakonie-Klinikum Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557044
- Sponsor's protocol ID
- Diak 001/2024
- Acronym
- PENG
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty: a Prospective, Double-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06557044
- Acronym / sponsor ID
- PENG / Diak 001/2024
- Conditions
- Prospective, Randomized, Double-blind
- Keywords
- Pericapsular Nerve Group Block, hip endoprostheses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Diakonie-Klinikum StuttgartUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the analgesic efficacy of the pericapsular nerve group (PENG) block during the implantation of hip endoprostheses. The study is designed as a prospective randomized double-blind study and the study participants were randomized into 2 arms and either 20 ml ropivacaine 0.5% (verum group) or 20 ml physiological saline solution (placebo group) will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum Group | Experimental | Drug: Ropivacaine20 ml ropivacaine 0.5% |
| Placebo Group | Placebo comparator | Other: Physiological saline20 ml physiological saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- planned cementless hip TEP operation for primary coxarthrosis via minimally invasive anterolateral approach using the identical implant system (Taperloc stem, Plamafit cup)
- Patient capable of giving consent
- Informed consent has been obtained
- age > 18 years
Key exclusion criteria (10 listed)
- Refusal to participate in the study
- Regular use of opioids
- Known chronic pain symptoms
- Infections in the area of the puncture site
- Presence of a contraindication to ropivacaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacainePENG block with ropivacaine | Drug | Verum Group |
| Physiological salinePlacebo control | Other | Placebo Group |
Primary outcome
Rate of postoperative opioid administration
Time frame: 60 minutes after arrival in the recovery room
The primary objective is to investigate the influence of the PENG block on the need for postoperative ntravenously opioid administration within the first hour in the recovery room.
4 secondary outcomes
Quantity of total opioid consumption
Time frame: until the evening of the second postoperative day
Intensity of postoperative pain
Time frame: until the evening of the second postoperative day
Intensity of postoperative nausea and vomiting
Time frame: until the evening of the second postoperative day
Postoperative recovery
Time frame: until the evening of the second postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and Physiological saline in people with Prospective and Randomized, run by Diakonie-Klinikum Stuttgart at 1 site in Germany.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rainer Meierhenrich, Prof. Dr. (00497119912290, meierhenrich@diak-stuttgart.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative opioid administration (time frame: 60 minutes after arrival in the recovery room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2024.