Volume Effect in Peng Block for Total Hip Replacement (volupeng)
May 19, 2024 updated by: Serena Ricalzone, Azienda Ospedaliero, Universitaria Pisana
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Toscana
-
Pisa, Toscana, Italy, 56124
- Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients underwent total hip replacement in elective surgery
Description
Inclusion Criteria:
- ASA I, ASA II, ASA III
- Age≥18
- Total hip replacement surgery in spinal anesthesia
- Informed consent
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
The local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, ≥80kg: 180mg)
|
|
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
|
The local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, ≥80kg: 180mg)
|
|
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
|
The local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, ≥80kg: 180mg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
24h post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NRS variation in time
Time Frame: 24 h
|
consider variation of pain, assessed with numeric Pain scale, for each group, every six hours
|
24 h
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
presence of side effects
Time Frame: 24 hours
|
Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours
|
24 hours
|
|
analgesic requirements
Time Frame: 24 hours
|
requirement of analgesic to control the pain, assessed every six hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: manuela nicastro, MD, aoupisa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
January 30, 2024
Study Completion (Actual)
January 30, 2024
Study Registration Dates
First Submitted
April 26, 2024
First Submitted That Met QC Criteria
May 19, 2024
First Posted (Actual)
May 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 19, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VOLUPENG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.