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.

January 14, 2022 updated by: Jean François Brichant, University of Liege

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège
        • Contact:
          • Michele Carella, MD
          • Phone Number: 003242843658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Drug: Ropivacaine 0,75% in PENG block
20 ml injection of ropivacaine 0,75%
Active Comparator: 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.
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.
Drug: Ropivacaine 0,375% in SFICB block
40 ml injection of ropivacaine 0,375%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS 6 hours
Time Frame: 6 hours after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minutes walk test
Time Frame: 48 jours after surgery
Difference in traveled distance (metres) at six minutes walking test 48 hours after surgery
48 jours after surgery
Opioids secondaires side effects
Time Frame: 48 hours after surgery
Incidence of morphine related side effects in two groups
48 hours after surgery
QoR-15
Time Frame: 72 hours after surgery
QoR-15 French validated questionnaire for the evaluation of recovery after surgery
72 hours after surgery
2 minutes walk test
Time Frame: 24 hours after surgery
Difference in traveled distance (metres) at two minutes walking test 24 hours after surgery
24 hours after surgery
Opioid sparing
Time Frame: 48 hours after intervention
Difference in cumulated morphine consumption in first 48 hours after surgery
48 hours after intervention
DN4
Time Frame: 72 hours after surgery
Difference between the two groups in the DN4 questionnaire to assess the risk of persistent pain after surgery.
72 hours after surgery
IPO
Time Frame: 72 hours after surgery
Pain management satisfaction score by revised American Pain Society Patient Outcomes Questionnaire (APS- POQ-R).
72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

December 28, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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