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CompletedNCT06427551volupengUpdated May 24, 2024

Volume Effect in Peng Block for Total Hip Replacement

An observational study in Anesthesia and Post Operative Pain, sponsored by Azienda Ospedaliero, Universitaria Pisana. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.

Sponsored by Azienda Ospedaliero, Universitaria Pisana · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Anesthesia
  • Post Operative Pain

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Keywords

  • postoperative
  • orthopedic surgery
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 120 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana is the lead sponsor of 56 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients underwent total hip replacement in elective surgery

Inclusion criteria

  • ASA I, ASA II, ASA III
  • Age≥18
  • Total hip replacement surgery in spinal anesthesia
  • Informed consent

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    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

    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

    Drug: Ropivacaine

Interventions

  • DrugRopivacaine

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: 24 h

Other outcomes

  1. 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

    Time frame: 24 hours

  2. analgesic requirements

    requirement of analgesic to control the pain, assessed every six hours

    Time frame: 24 hours

07

Study locations

1 site
  • Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello
    Pisa, Toscana 56124, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06427551
Lead sponsor
Azienda Ospedaliero, Universitaria Pisana
Responsible party
Serena Ricalzone (principal investigator, Azienda Ospedaliero, Universitaria Pisana) — Principal investigator
First posted
May 24, 2024
Start date
Jan 1, 2022
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024
Last update
May 24, 2024

Study contacts

manuela nicastro, MD
study director · aoupisa

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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