Clinical trial NCT04690023: 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.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Total Hip Arthroplasty
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: NRS 6 hours
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: 6 minutes walk test
timeFrame: 48 jours after surgery
measure: Opioids secondaires side effects
timeFrame: 48 hours after surgery
measure: QoR-15
timeFrame: 72 hours after surgery
measure: 2 minutes walk test
timeFrame: 24 hours after surgery
measure: Opioid sparing
timeFrame: 48 hours after intervention
measure: DN4
timeFrame: 72 hours after surgery
measure: IPO
timeFrame: 72 hours after surgery
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
References:
citation: 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.
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:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.