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.

NCT ID: NCT04690023

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-09-01

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.

Conditions

Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pericapsular nerves group (PENG) block

Intervention Type: PROCEDURE

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.

Ropivacaine 0,75% in PENG block

Intervention Type: DRUG

20 ml injection of ropivacaine 0,75%

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.

Group Type: ACTIVE_COMPARATOR

Supra-inguinal fascia-iliaca compartment block

Intervention Type: PROCEDURE

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.

Ropivacaine 0,375% in SFICB block

Intervention Type: DRUG

40 ml injection of ropivacaine 0,375%

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Ropivacaine 0,75% in PENG block

20 ml injection of ropivacaine 0,75%

Intervention Type: DRUG

Ropivacaine 0,375% in SFICB block

40 ml injection of ropivacaine 0,375%

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Jean François Brichant

Head of Anesthesiology Departement

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU de Liège

Liège, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Michele Carella, MD

Role: CONTACT

mcarella@chuliege.be

003242843658

Facility Contacts

Michele Carella, MD

Role: primary

003242843658

References

Giron-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.

Reference Type: BACKGROUND

PMID: 30063657 (View on PubMed)

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:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.

Reference Type: BACKGROUND

PMID: 30798268 (View on PubMed)

Other Identifiers

2020/381

Identifier Type: -

Identifier Source: org_study_id