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Clinical Trials/NCT04306133
NCT04306133
Completed
Not Applicable

Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial

Campus Bio-Medico University1 site in 1 country60 target enrollmentMarch 9, 2020
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ConditionsPostoperative PainAnalgesiaHip ArthropathyAcute PainPainPostoperative Complications

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Campus Bio-Medico University
Enrollment
60
Locations
1
Primary Endpoint
Maximum Pain Score
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement.

Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.

Registry
clinicaltrials.gov
Start Date
March 9, 2020
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Campus Bio-Medico University
Responsible Party
Principal Investigator
Principal Investigator

Giuseppe Pascarella

Principal Investigator

Campus Bio-Medico University

Eligibility Criteria

Inclusion Criteria

  • •Elective hip replacement surgery
  • •ASA physical status score \< 4

Exclusion Criteria

  • •Contraindications to regional anesthesia
  • •ASA physical status score ≥ 4
  • •Patient's refusal or inability to sing the informed consent
  • •Pre-operatively therapy with opioids
  • •Allergies to any drug provided by the study protocol

Outcomes

Primary Outcomes

Maximum Pain Score

Time Frame: 24 hours

A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) will be used to evaluate pain during 48 h after surgery

Total opioids consumption

Time Frame: 48 hours

Total of Sublingual Sufentanil tablets released

Secondary Outcomes

  • Incidence of block complications(48 hours)
  • Opioids side effects(48 hours)
  • Time to first opioid(48 hours)
  • Range of hip motion(24 hours)
  • Time to ambulation(48 hours)
  • Quadriceps weakness(48 hours)

Study Sites (1)

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