Volume Effect in Peng Block for Total Hip Replacement

Anesthesia Clinical Trial

— volupeng  

Official title:

Peng Block in Total Hip Replacement: Effects of Anesthetic Volume on Clinical Outcome and Postoperative Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06427551
• Other study ID #: VOLUPENG
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: May 2024
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Ropivacaine
The local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, =80kg: 180mg)

Locations

Country	Name	City	State
Italy	Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello	Pisa	Toscana

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	presence of side effects	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
Other	analgesic requirements	requirement of analgesic to control the pain, assessed every six hours	24 hours
Primary	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.	24h post-op
Secondary	NRS variation in time	consider variation of pain, assessed with numeric Pain scale, for each group, every six hours	24 h