Bach Mai Hospital
Hanoi, 100000, Vietnam
NCT Number: NCT07516795
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Hanoi, 100000, Vietnam
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
Other names: Continuous Sacral ESP Block, Continuous Sacral ESPB
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.
Other names: Continuous Fascia Iliaca Block, Continuous FICB, Continuous Fascia Iliaca Compartment Block (CFICB)
Time frame: 0 to 72 hours after block placement
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.
Time frame: 0-24 h and 24-48 h after block placement
Total rescue opioid consumption (MME) during 0-24 h and 24-48 h intervals.
Time frame: 0 to 72 hours after block placement
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.
Time frame: 0 to 72 hours after block placement
Pain scores during hip flexion (active movement) assessed using 0-10 Visual Analog Scale at the same time points.
Time frame: 72 hours after block placement
Total QoR-15 score (range 0-150) assessing quality of recovery at 72 hours postoperatively. Higher scores indicate better recovery.
Time frame: 24 and 72 hours after block placement
Motor block assessed by modified Bromage scale (0 = no motor block, 3 = complete motor block) at 24 and 72 hours.
Time frame: 0 to 72 hours after block placement
Number of participants with nausea/vomiting, pruritus, urinary retention, catheter-related complications (dislodgement/occlusion), local anesthetic systemic toxicity, hematoma, infection, or neurological deficit.
Bach Mai Hospital
Other
Continuous Sacral Erector Spinae Plane Block Versus Continuous Fascia Iliaca Compartment Block for Postoperative Analgesia After Total Hip Arthroplasty: a Randomized Clinical Trial
Acronym: SESP-HIP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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