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Active Not Recruiting
NCT07516795
Analgesic Efficacy of Continuous SESP vs Continuous FICB After Hip Arthroplasty
Conditions: Pain, Postoperative; Anesthesia, Regional, Arthroplasty, Replacement, Hip
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Bach Mai Hospital
Location: Bach Mai Hospital Hanoi Hanoi
Summary
The primary objective of this prospective, randomized, observer-blinded controlled trial is to compare the postoperative analgesic efficacy of continuous intermediate-approach sacral erector spinae plane (SESP) block versus continuous supra-inguinal fascia iliaca compartment block (FICB) in adult patients undergoing elective posterior-approach total hip arthroplasty under spinal anesthesia.
Sixty patients will be randomly allocated to receive either a continuous SESP block or a continuous supra-inguinal FICB. Both techniques involve an initial bolus of 20 mL 0.2% ropivacaine followed by intermittent boluses of 10 mL 0.2% ropivacaine every 6 hours for 72 hours via an indwelling catheter, in addition to standardized multimodal analgesia. The primary outcome is cumulative morphine milligram equivalents (MME) consumption over the first 72 postoperative hours. Secondary outcomes include pain scores at rest and during movement (VAS), quality of recovery (QoR-15) at 72 hours, motor function (modified Bromage scale), and adverse events.
We hypothesize that continuous SESP block will provide superior opioid-sparing analgesia compared with continuous supra-inguinal FICB while maintaining comparable pain control, quality of recovery, and motor function preservation.
Eligibility Criteria
Inclusion Criteria:
Adult patients aged 18 to 80 years. Scheduled for elective primary unilateral total hip arthroplasty due to osteoarthritis (not due to hip fracture or trauma).
American Society of Anesthesiologists (ASA) physical status I, II, or III. Ability to understand and cooperate with study procedures, including postoperative pain assessment using the Visual Analog Scale (VAS) and follow-up evaluations.
Provided written informed consent to participate in the study.
Exclusion Criteria:
Patient refusal to participate or inability to provide informed consent. Contraindications to regional anesthesia or peripheral nerve blocks (e.g., coagulopathy, therapeutic anticoagulation, infection at the injection site, or severe spinal deformity).
Known allergy or hypersensitivity to local anesthetics (ropivacaine or bupivacaine).
Previous surgery on the same hip. Severe cardiopulmonary disease (e.g., NYHA class III-IV, severe COPD) that may interfere with postoperative recovery assessment.
Neurological disorders affecting the lower extremities (e.g., stroke with residual motor deficit, peripheral neuropathy).
Cognitive impairment or inability to cooperate with catheter care and follow-up assessments.
Pregnancy or breastfeeding.
Source: ClinicalTrials.gov (NCT07516795). StuddyBuddy aggregates publicly available trial information.