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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.

U

University of Liege

Status and phase

Unknown
Phase 4

Conditions

Total Hip Arthroplasty

Treatments

Drug: Ropivacaine 0,75% in PENG block
Drug: Ropivacaine 0,375% in SFICB block
Procedure: Pericapsular nerves group (PENG) block
Procedure: Supra-inguinal fascia-iliaca compartment block

Study type

Interventional

Funder types

Other

Identifiers

NCT04690023
2020/381

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 2 patient groups

PENG block
Active Comparator group
Description:
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.
Treatment:
Drug: Ropivacaine 0,75% in PENG block
Procedure: Pericapsular nerves group (PENG) block
SFICB block
Active Comparator group
Description:
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.
Treatment:
Drug: Ropivacaine 0,375% in SFICB block
Procedure: Supra-inguinal fascia-iliaca compartment block

Trial contacts and locations

1

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Central trial contact

Michele Carella, MD

Data sourced from clinicaltrials.gov

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