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.

Total Hip Arthroplasty Clinical Trial

Official title:

Comparison of Ultrasound-guided PENG Block and Supra-inguinal Fascia Iliaca Compartment Block for Postoperative Opioids Consumption and Early Motor Recovery After Total Hip Arthroplasty: a Randomized Controlled Non-inferiority Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04690023
• Other study ID #: 2020/381
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2022
• Source: University of Liege
• Contact: Michele Carella, MD
• Phone: 003242843658
• Email: mcarella[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: September 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Procedure:
• Pericapsular nerves group (PENG) block
Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block with injection 20 ml of ropivacaine 0,75%, between the anterior hip articular capsule, the ilii-psoas muscle, the ileo-pubic eminence and the antero-inferior iliac spine.
• 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 with injection over de inguinal ligament of 40 ml of ropivacaine 0,375%, between de ilio-psoas muscle and internal oblique muscle.

Drug:
• Ropivacaine 0,75% in PENG block
20 ml injection of ropivacaine 0,75%
• Ropivacaine 0,375% in SFICB block
40 ml injection of ropivacaine 0,375%

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

Girón-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. — View Citation

Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22. pii: rapm-2018-100092. doi: 10.1136/rapm-2018-100092. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS 6 hours	The primary endpoint of the study will be the between-group comparisons in postoperative NRS pain scores on 0 to 10 scale.	6 hours after surgery
Secondary	6 minutes walk test	Difference in traveled distance (metres) at six minutes walking test 48 hours after surgery	48 jours after surgery
Secondary	Opioids secondaires side effects	Incidence of morphine related side effects in two groups	48 hours after surgery
Secondary	QoR-15	QoR-15 French validated questionnaire for the evaluation of recovery after surgery	72 hours after surgery
Secondary	2 minutes walk test	Difference in traveled distance (metres) at two minutes walking test 24 hours after surgery	24 hours after surgery
Secondary	Opioid sparing	Difference in cumulated morphine consumption in first 48 hours after surgery	48 hours after intervention
Secondary	DN4	Difference between the two groups in the DN4 questionnaire to assess the risk of persistent pain after surgery.	72 hours after surgery
Secondary	IPO	Pain management satisfaction score by revised American Pain Society Patient Outcomes Questionnaire (APS- POQ-R).	72 hours after surgery