Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Main indications for total hip arthroplasty (THA) are degenerative osteoarthritis of the coxofemoral joint, osteonecrosis of the hip, congenital disorders such as dysplasia and inflammatory arthritis. More recently, surgery using the direct anterior approach is getting popularity: this method, in fact, granting a significant sparing of the hip muscles, is associated with favorable results compared to other techniques, such as a lower risk of dislocation, limitated damage to soft tissues with better recovery and early discharge.
Patients undergoing this procedure may although experience moderate to severe postoperative pain in the first few hours (with peaks observed in the first 12 hours), as well as potential complications such as nausea and vomiting related to opioids use.
It has been shown that adequate pain control influences early mobilization and rehabilitation, ensuring a quicker recovery. The role of regional anesthesia techniques has been established in almost all areas of orthopedic surgery, and in particularly in the management of postoperative pain following hip replacement surgery, but definitive data are missing with regard to direct anterior approach.
Regional anesthesia consists of infiltrating local anesthetics in sites (fascial planes or nerves), in order to limit or even eliminate the use of traditional painkillers, with a significant reduction in the side effects.
The aim of this study is to compare the impact of two techniques, the Suprainguinal Fascia Iliaca (SIFI) block and the lumbar Erector Spinae Plane (ESP) block, in managing postoperative pain in subjects undergoing total hip replacement surgery performed by direct anterior approach.
The primary objective of the study is the incidence of residual femoral and obturator nerves block (knee extension and hip adduction according to ASIA score) 8 hours after surgery in the two treatment groups.
Secondary objectives include: • Time elapsed between the end of surgery and the recovery of lower limb motility enough to allow the patient to mobilize independently; • Total opioid consumption (calculated as morphine equivalents) at 8, 24 and 48 hours after surgery; • Pain according to NRS (numerica rating scale) at 8, 24 and 48 hours after surgery; • Extent of sensory block of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves) at 8, 24 and 48 hours after surgery; • Timing of hospital discharge; • Incidence of chronic or persistent postoperative pain (at 30 and 90 days after surgery); • Any postoperative complication
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects udergoing SIFI block | Experimental |
| |
| Subjects udergoing ESP block | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIFI Block | Procedure | Infiltration of local anesthetics in the suprainguinal iliac fascia (Ropivacaine 0.375 40 mls) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of residual femoral and obturator nerves block in the two treatment groups | (knee extension and hip adduction according to ASIA score) | 8 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time elapsed between the end of surgery and the recovery of lower limb motility | Ability of patient to mobilize independently within the room | 8 (or more) hours after surgery |
| Total opioid consumption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Ulla, MD | Contact | 0039-3397548673 | marco.ulla@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza | Recruiting | Torino | TO | 10126 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ESP block | Procedure | Infiltration of local anesthetics in the fascial plane underneath the erector spoinae mulscle at lumbar level (Ropivacaine 0.375 40 mls) |
|
Calculated as morphine equivalents
| 8, 24 and 48 hours after surgery |
| Pain according to NRS (Numeric Rating Scale) | Scale 1-10 (1 corresponding to minimum and 10 corresponding to maximum pain perceived) | 8, 24 and 48 hours after surgery |
| Extent of sensory block | Clinical evaluation of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves) | 8, 24 and 48 hours after surgery |
| Incidence of postoperative complications | Bleeding, Bradyarrhythmic and/or hypotensive events, Nausea and Vomiting | Up to 48 hrs after surgery |
| Timing of hospital discharge | From enrolment to the first follow up at 30 days |
| Incidence of chronic or persistent postoperative pain | Follow-up by phone, using Brief Pain Inventory (presence of pain/localization/characteristics) and DN4 (neuropathic component) questionnaires. | 30 and 90 days after surgery |
| Incidence of acute side effects related to opioid use | excessive sedation, nausea and vomiting, respiratory depression, pruritus, urinary retention, constipation | Up to 48 hours after surgery |
| Incidence of complications related to nerve blocks | block failure, nerve damage, hematomas, systemic toxicity from local anesthetics | up to 48 hours after surgery |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided