PENG Block vs Supra-inguinal Fascia Iliaca Compartment Block for Postoperative Opioids Consumption and Early Motor Recovery After THA: a Randomized Controlled Non-inferiority Clinical Trial.

Phase 4

• Conditions: Total Hip Arthroplasty
• Interventions: Procedure: Pericapsular nerves group (PENG) block; Procedure: Supra-inguinal fascia-iliaca compartment block; Drug: Ropivacaine 0,75% in PENG block; Drug: Ropivacaine 0,375% in SFICB block

• Registration Number: NCT04690023
• Lead Sponsor: University of Liege

Brief Summary

To compare the impact of pericapsular nerve group block (PENG) versus the supra-inguinal fascia-iliaca compartment block (SFICB) in postoperative analgesia, opioid sparing and enhanced recovery after surgery of total hip arthroplasty by poster-lateral approach.

Detailed Description

ASA physical status 1, 2 and 3 patients scheduled to undergo elective total hip arthroplasty by poster-lateral (Moore) surgical approach with spinal anesthesia.

The investigators want to confirm the non-inferiority of the SFICB compared to the PENG block on postoperative first 6 hours after surgery NRS pain score and 48 hours opioids consumption, and the difference between these in terms of early recovery and motor impact on two first day after surgery. The principal investigator perform these regional anesthesia techniques with ultrasound guided injections.

Study Timeline

• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-30
• Status Verified: 2022-01
• Study Start: 2022-01-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-19
• Primary Completion: 2023-03-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Adults patients scheduled to undergo elective primary total hip arthroplasty by posterior surgical approach with spinal anesthesia

Exclusion Criteria

• Patient refusal
• Allergy to administrated drugs or local infection
• Pregnancy
• History of chronic pain
• Drugs addiction
• Mental ou neurological diseases
• Kidney or liver serious diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENG block	Ropivacaine 0,75% in PENG block	Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block. Patients in PENG group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump.
PENG block	Pericapsular nerves group (PENG) block	Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block. Patients in PENG group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump.
SFICB block	Supra-inguinal fascia-iliaca compartment block	Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block. Patients in SFICB group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump.
SFICB block	Ropivacaine 0,375% in SFICB block	Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block. Patients in SFICB group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump.

Primary Outcome Measures

Name	Time	Method
NRS 6 hours	6 hours after surgery	The primary endpoint of the study will be the between-group comparisons in postoperative NRS pain scores on 0 to 10 scale.

Secondary Outcome Measures

Name	Time	Method
6 minutes walk test	48 jours after surgery	Difference in traveled distance (metres) at six minutes walking test 48 hours after surgery
Opioids secondaires side effects	48 hours after surgery	Incidence of morphine related side effects in two groups
QoR-15	72 hours after surgery	QoR-15 French validated questionnaire for the evaluation of recovery after surgery
2 minutes walk test	24 hours after surgery	Difference in traveled distance (metres) at two minutes walking test 24 hours after surgery
Opioid sparing	48 hours after intervention	Difference in cumulated morphine consumption in first 48 hours after surgery
DN4	72 hours after surgery	Difference between the two groups in the DN4 questionnaire to assess the risk of persistent pain after surgery.
IPO	72 hours after surgery	Pain management satisfaction score by revised American Pain Society Patient Outcomes Questionnaire (APS- POQ-R).

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium