PENG Block Combined to Wound Infiltration for Hip Replacement

Not Applicable

Completed

• Conditions: Postoperative Complications; Postoperative Pain; Hip Arthropathy; Acute Pain; Analgesia; Pain
• Interventions: Procedure: Wound Infiltration; Procedure: PENG block

• Registration Number: NCT04306133
• Lead Sponsor: Campus Bio-Medico University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-08
• Study Start: 2020-03-09
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Primary Completion: 2020-12-24
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WOUND INFILTRATION	Wound Infiltration	Participants receiving wound infiltration alone
PENG BLOCK AND WOUND INFILTRATION	PENG block	Participants receiving PENG block combined to wound infiltration
PENG BLOCK AND WOUND INFILTRATION	Wound Infiltration	Participants receiving PENG block combined to wound infiltration

Primary Outcome Measures

Name	Time	Method
Maximum Pain Score	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	48 hours	Total of Sublingual Sufentanil tablets released

Secondary Outcome Measures

Name	Time	Method
Incidence of block complications	48 hours	Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.
Opioids side effects	48 hours	The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting
Time to first opioid	48 hours	Time (hours) from the end of surgery to the first opioid administration
Range of hip motion	24 hours	Degrees of hip flexion
Time to ambulation	48 hours	Time until the patient is able to stand up and walk with or without assistive devices
Quadriceps weakness	48 hours	Presence of weakness of the quadriceps using a scale where 0= no effect; 1 = knee flexion possible but not hip flexion; 2 = absence of knee and hip flexion

Trial Locations

Locations (1)

Università Campus Biomedico; 🇮🇹 Roma, Italy