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| ID | Type | Description | Link |
|---|---|---|---|
| BM-2025-33 | Other Identifier | Institutional Review Board of Bach Mai Hospital |
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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.
Effective postoperative pain management after total hip arthroplasty (THA) via the posterior approach remains challenging because the surgical site receives innervation from both the lumbar and sacral plexuses. Multimodal analgesia incorporating regional anesthesia techniques is recommended to minimize opioid consumption and facilitate early rehabilitation. However, the optimal continuous regional technique for posterior THA has not been clearly established.
This prospective, randomized, observer-blinded trial compares two continuous ultrasound-guided regional analgesia techniques in patients undergoing elective posterior-approach THA under spinal anesthesia. Eligible adult patients (ASA I-III) are randomized in a 1:1 ratio to receive either continuous intermediate-approach sacral erector spinae plane (SESP) block or continuous supra-inguinal fascia iliaca compartment block (FICB).
In the SESP group, with the patient in the lateral decubitus position, a catheter is placed in the interfascial plane between the erector spinae muscle and the intermediate sacral crest under ultrasound guidance. In the FICB group, with the patient supine, a catheter is placed in the fascia iliaca compartment using the supra-inguinal approach with identification of the characteristic bow-tie sign. Both groups receive an initial bolus of 20 mL 0.2% ropivacaine followed by intermittent boluses of 10 mL 0.2% ropivacaine every 6 hours for a total of 72 hours via the indwelling catheter. All patients receive standardized multimodal analgesia consisting of intravenous paracetamol and diclofenac, with intravenous fentanyl PCA as rescue analgesia.
The primary outcome is cumulative opioid consumption expressed as morphine milligram equivalents (MME) during the first 72 postoperative hours. Key secondary outcomes include visual analog scale (VAS) pain scores at rest and during hip flexion at multiple time points up to 72 hours, the Quality of Recovery-15 (QoR-15) score at 72 hours, motor function assessed by the modified Bromage scale at 24 and 72 hours, and the incidence of adverse events. Outcome assessors, ward staff, and data analysts remain blinded to group allocation throughout the study period.
This trial aims to determine whether continuous SESP block provides clinically meaningful opioid-sparing benefits compared with continuous supra-inguinal FICB in patients undergoing posterior THA, without compromising recovery quality or safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous SESP | Experimental | Patients in this arm will receive an ultrasound-guided continuous Sacral Erector Spinae Plane (SESP) block for postoperative analgesia following hip replacement surgery. |
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| Continuous FICB | Active Comparator | Patients in this arm will receive an ultrasound-guided continuous Fascia Iliaca Compartment Block (FICB) for postoperative analgesia following hip replacement surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Sacral Erector Spinae Plane Block | Procedure | Under ultrasound guidance, a catheter is inserted into the sacral erector spinae plane. A continuous infusion of local anesthetic (e.g., 0.2% Ropivacaine) is administered via the catheter for 72 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Morphine Milligram Equivalents (MME) Consumption at 72 Hours Postoperatively | Total cumulative consumption of rescue opioid analgesics administered from the completion of surgery until 72 hours postoperatively, converted to intravenous morphine milligram equivalents (MME). A higher value indicates greater opioid requirement. | 0 to 72 hours after block placement |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative MME Consumption at 24 Hours and 48 Hours Postoperatively | Total rescue opioid consumption (MME) during 0-24 h and 24-48 h intervals. | 0-24 h and 24-48 h after block placement |
| Pain Intensity at Rest (VAS) |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bach Mai Hospital | Hanoi | Hanoi | 100000 | Vietnam |
Public sharing of IPD is not planned due to patient confidentiality regulations in Vietnam. However, completely de-identified data underlying the results reported in this study may be made available to qualified researchers upon a reasonable and methodologically sound request, strictly subject to approval by the Principal Investigator and the Institutional Review Board.
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Eligible patients are randomly assigned to one of two parallel groups (SESP or FICB) in a 1:1 ratio.
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Outcome assessors, ward nurses administering multimodal analgesia, and data analysts were blinded to group allocation. Patients and anesthesiologists performing the blocks could not be blinded due to the distinct anatomical locations of the two interventions.
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| Continuous Fascia Iliaca Compartment Block | Procedure | Under ultrasound guidance, a catheter is inserted deep to the fascia iliaca. A continuous infusion of local anesthetic (e.g., 0.2% Ropivacaine) is administered via the catheter for 72 hours postoperatively. |
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Pain scores at rest assessed using 0-10 Visual Analog Scale at 0, 2, 6, 12, 24, 36, 48, and 72 hours after block placement.
| 0 to 72 hours after block placement |
| Pain Intensity During Movement (VAS) | Pain scores during hip flexion (active movement) assessed using 0-10 Visual Analog Scale at the same time points. | 0 to 72 hours after block placement |
| Quality of Recovery-15 (QoR-15) Score at 72 Hours | Total QoR-15 score (range 0-150) assessing quality of recovery at 72 hours postoperatively. Higher scores indicate better recovery. | 72 hours after block placement |
| Motor Function (Modified Bromage Scale) | Motor block assessed by modified Bromage scale (0 = no motor block, 3 = complete motor block) at 24 and 72 hours. | 24 and 72 hours after block placement |
| Incidence of Adverse Events | Number of participants with nausea/vomiting, pruritus, urinary retention, catheter-related complications (dislodgement/occlusion), local anesthetic systemic toxicity, hematoma, infection, or neurological deficit. | 0 to 72 hours after block placement |