Skip to main content
OpenTrials
Completed

NCT Number: NCT06427551

Volume Effect in Peng Block for Total Hip Replacement

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello

Pisa, Tuscany, 56124, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. NRS variation in time

    Time frame: 24 h

    consider variation of pain, assessed with numeric Pain scale, for each group, every six hours

Other outcomes

  1. 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

  2. analgesic requirements

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

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

Acronym: volupeng

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 24, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.