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.

NCT04690023 | Unknown Phase 4 DMC

• 1 other identifier: 2020/381
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 6 minutes walk test

  48 jours after surgery

• Opioids secondaires side effects

  48 hours after surgery

• QoR-15

  72 hours after surgery

• 2 minutes walk test

  24 hours after surgery

• Opioid sparing

  48 hours after intervention

Study Arms (2)

PENG block

ACTIVE COMPARATOR

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.

Procedure: Pericapsular nerves group (PENG) block; Drug: Ropivacaine 0,75% in PENG block

SFICB block

ACTIVE COMPARATOR

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.

Procedure: Supra-inguinal fascia-iliaca compartment block; Drug: Ropivacaine 0,375% in SFICB block

Interventions

Pericapsular nerves group (PENG) block 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.

PENG block

Supra-inguinal fascia-iliaca compartment block 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.

SFICB block

Ropivacaine 0,75% in PENG block DRUG

20 ml injection of ropivacaine 0,75%

PENG block

Ropivacaine 0,375% in SFICB block DRUG

40 ml injection of ropivacaine 0,375%

SFICB block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

RECRUITING

Related Publications (2)

• 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.

  PMID: 30063657 BACKGROUND

• 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.

  PMID: 30798268 BACKGROUND

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Michele Carella, MD

CONTACT

003242843658; mcarella@chuliege.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Non-inferiority controlled RCT with two groups simple-blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology Departement

Model Details: Non-inferiority randomized controlled clinical trial

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 30, 2020
• Study Start: January 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)