An interventional study of SIFI Block and ESP block in Hip Replacement Surgery, Hip Replacement, Total and Hip Pain, sponsored by A.O.U. Città della Salute e della Scienza. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by A.O.U. Città della Salute e della Scienza · Not applicable, Interventional, and Treatment
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
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 50 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →A.O.U. Città della Salute e della Scienza is the lead sponsor of 65 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: SIFI Block
Procedure: ESP block
Infiltration of local anesthetics in the suprainguinal iliac fascia (Ropivacaine 0.375 40 mls)
Infiltration of local anesthetics in the fascial plane underneath the erector spoinae mulscle at lumbar level (Ropivacaine 0.375 40 mls)
Incidence of residual femoral and obturator nerves block in the two treatment groups
(knee extension and hip adduction according to ASIA score)
Time frame: 8 hours after surgery
Time elapsed between the end of surgery and the recovery of lower limb motility
Ability of patient to mobilize independently within the room
Time frame: 8 (or more) hours after surgery
Total opioid consumption
Calculated as morphine equivalents
Time frame: 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)
Time frame: 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)
Time frame: 8, 24 and 48 hours after surgery
Incidence of postoperative complications
Bleeding, Bradyarrhythmic and/or hypotensive events, Nausea and Vomiting
Time frame: Up to 48 hrs after surgery
Timing of hospital discharge
Time frame: 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.
Time frame: 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
Time frame: Up to 48 hours after surgery
Incidence of complications related to nerve blocks
block failure, nerve damage, hematomas, systemic toxicity from local anesthetics
Time frame: up to 48 hours after surgery
Plan to share: No
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A.O.U. Città della Salute e della Scienza