Volume Effect in Peng Block for Total Hip Replacement

NCT06427551 | Completed

• 1 other identifier: VOLUPENG
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Post Operative Pain

Keywords

postoperative; orthopedic surgery

Outcome Measures

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.

  24h post-op

Secondary Outcomes (1)

• NRS variation in time

  24 h

Other Outcomes (2)

• presence of side effects

  24 hours

• analgesic requirements

  24 hours

Study Arms (3)

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

Ropivacaine DRUG

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

15 ml local anesthetic; 20 ml local anesthetic; 30 ml local anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients underwent total hip replacement in elective surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello

Pisa, Tuscany, 56124, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• manuela nicastro, MD

  aoupisa

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 24, 2024
• Study Start: January 1, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)