Volume Effect in Peng Block for Total Hip Replacement

Completed

• Conditions: Post Operative Pain; Anesthesia
• Interventions: Drug: Ropivacaine

• Registration Number: NCT06427551
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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.

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 Timeline

• Study Start: 2022-01-01
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Study First Submitted: 2024-04-26
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-19
• Last Update Submitted: 2024-05-19
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
30 ml local anesthetic	Ropivacaine	in this group of patients the peng block was performed with 30 ml of ropivacaine, whose dose was obtained on the weight
20 ml local anesthetic	Ropivacaine	in this group of patients the peng block was performed with 20 ml of ropivacaine, whose dose was obtained on the weight
15 ml local anesthetic	Ropivacaine	in this group of patients the peng block was performed with 15 ml of ropivacaine, whose dose was obtained on the weight

Primary Outcome Measures

Name	Time	Method
NRS evaluation	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 Outcome Measures

Name	Time	Method
NRS variation in time	24 h	consider variation of pain, assessed with numeric Pain scale, for each group, every six hours

Trial Locations

Locations (1)

Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello; 🇮🇹 Pisa, Toscana, Italy