Total Hip Arthroplasty
Conditions
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.
Interventions
PROCEDUREPericapsular 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.
PROCEDURESupra-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.
DRUGRopivacaine 0,75% in PENG block
20 ml injection of ropivacaine 0,75%
DRUGRopivacaine 0,375% in SFICB block
40 ml injection of ropivacaine 0,375%
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Non-inferiority controlled RCT with two groups simple-blinded
Intervention model description
Non-inferiority randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS 6 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioids secondaires side effects | 48 hours after surgery | Incidence of morphine related side effects in two groups |
| QoR-15 | 72 hours after surgery | QoR-15 French validated questionnaire for the evaluation of recovery after surgery |
| 2 minutes walk test | 24 hours after surgery | Difference in traveled distance (metres) at two minutes walking test 24 hours after surgery |
| 6 minutes walk test | 48 jours after surgery | Difference in traveled distance (metres) at six minutes walking test 48 hours after surgery |
| DN4 | 72 hours after surgery | Difference between the two groups in the DN4 questionnaire to assess the risk of persistent pain after surgery. |
| IPO | 72 hours after surgery | Pain management satisfaction score by revised American Pain Society Patient Outcomes Questionnaire (APS- POQ-R). |
| Opioid sparing | 48 hours after intervention | Difference in cumulated morphine consumption in first 48 hours after surgery |
Countries
Belgium
Contacts
Primary ContactMichele Carella, MD
Outcome results
None listed