AnesthesiavolupengNCT06427551
Volume Effect in Peng Block for Total Hip Replacement
An observational study of Anesthesia and Post Operative Pain, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
This study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Post Operative Pain
- What is being tested?
- Ropivacaine
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 30 Jan 2024
- Phase
- Observational
- 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
Study population: Patients underwent total hip replacement in elective surgery
Who may be able to join
- ASA I, ASA II, ASA III
- Age≥18
- Total hip replacement surgery in spinal anesthesia
- Informed consent
Who cannot join
- ASA IV
- INR>1.3
- platelet values<100*10^3/ml a
- patients on anticoagulant or antiplatelet therapy
- general anesthesia for total hip replacement surgery
- patients on chronic opioid therapy
Show all 11Show fewer
- altered sensitivity or motility
- Patients in chronic opioid therapy
- Refuse to sign informed consent form
- Unable to sign informed consent form
- Know allergies to medication used for analgesia
Trial locations and contacts
1 site in 1 country.
Italy1 site
Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello
Pisa, Tuscany, 56124
About this study
Official title: Peng Block in Total Hip Replacement: Effects of Anesthetic Volume on Clinical Outcome and Postoperative Complications
This study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively.
Read the detailed description
patients were divided into 3 groups on the basis of the volume of anesthetic given to perform the block. in every patient was assessed the nrs, the side effects, if any, and the need for analgesic drugs in the first 24 hour after surgery
- Conditions
- Anesthesia, Post Operative Pain
- Being tested
- Ropivacaine
- Keywords
- postoperative, orthopedic surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
The local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, ≥80kg: 180mg)
| Study group | Role | What they receive |
|---|---|---|
| 15 ml local anesthetic | in this group of patients the peng block was performed with 15 ml of ropivacaine, whose dose was obtained on the weight Receives: Drug: Ropivacaine | |
| 20 ml local anesthetic | in this group of patients the peng block was performed with 20 ml of ropivacaine, whose dose was obtained on the weight Receives: Drug: Ropivacaine | |
| 30 ml local anesthetic | in this group of patients the peng block was performed with 30 ml of ropivacaine, whose dose was obtained on the weight Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS evaluation
Evaluate pain for every volume group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three.
Success of the block was defined as NRS≤3.
Measured: 24h post-op
Secondary outcomes (1)
NRS variation in time
consider variation of pain, assessed with numeric Pain scale, for each group, every six hours
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jan 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serena Ricalzone, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- manuela nicastro, MD, Study director, aoupisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427551
- Sponsor's protocol ID
- VOLUPENG
- Acronym
- volupeng
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peng Block in Total Hip Replacement: Effects of Anesthetic Volume on Clinical Outcome and Postoperative Complications
- ClinicalTrials.gov ID
- NCT06427551
- Acronym / sponsor ID
- volupeng / VOLUPENG
- Conditions
- Anesthesia, Post Operative Pain
- Keywords
- postoperative, orthopedic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 24 May 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.
This study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively.
Detailed description
patients were divided into 3 groups on the basis of the volume of anesthetic given to perform the block. in every patient was assessed the nrs, the side effects, if any, and the need for analgesic drugs in the first 24 hour after surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 ml local anesthetic | – | Drug: Ropivacainein this group of patients the peng block was performed with 15 ml of ropivacaine, whose dose was obtained on the weight |
| 20 ml local anesthetic | – | Drug: Ropivacainein this group of patients the peng block was performed with 20 ml of ropivacaine, whose dose was obtained on the weight |
| 30 ml local anesthetic | – | Drug: Ropivacainein this group of patients the peng block was performed with 30 ml of ropivacaine, whose dose was obtained on the weight |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent total hip replacement in elective surgery
Key inclusion criteria (4 listed)
- ASA I, ASA II, ASA III
- Age≥18
- Total hip replacement surgery in spinal anesthesia
- Informed consent
Key exclusion criteria (11 listed)
- ASA IV
- INR>1.3
- platelet values<100*10^3/ml a
- patients on anticoagulant or antiplatelet therapy
- general anesthesia for total hip replacement surgery
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 |
|---|---|---|
| RopivacaineThe local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, ≥80kg: 180mg) | Drug | 15 ml local anesthetic, 20 ml local anesthetic, 30 ml local anesthetic |
Primary outcome
NRS evaluation
Time frame: 24h post-op
Evaluate pain for every volume group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three. Success of the block was defined as NRS≤3.
1 secondary outcome
NRS variation in time
Time frame: 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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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.
manuela nicastro, MD study director
aoupisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Post Operative Pain, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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 11 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: finished, as of the sponsor's last update on 24 May 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 Italy. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS evaluation (time frame: 24h post-op). 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 24 May 2024.