Analgesic Efficacy of Continuous SESP vs Continuous FICB After Hip Arthroplasty (SESP-HIP)

Continuous Sacral Erector Spinae Plane Block Versus Continuous Fascia Iliaca Compartment Block for Postoperative Analgesia After Total Hip Arthroplasty: a Randomized Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthroplasty, Replacement, Hip; Pain, Postoperative; Anesthesia, Regional
• Intervention / Treatment: Procedure: Continuous Sacral Erector Spinae Plane Block; Procedure: Continuous Fascia Iliaca Compartment Block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi
    • Hanoi, Hanoi, Vietnam, 100000
      • Bach Mai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous FICB; Patients in this arm will receive an ultrasound-guided continuous Fascia Iliaca Compartment Block (FICB) for postoperative analgesia following hip replacement surgery.	Procedure: Continuous Fascia Iliaca Compartment Block; 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)
Experimental: Continuous SESP; Patients in this arm will receive an ultrasound-guided continuous Sacral Erector Spinae Plane (SESP) block for postoperative analgesia following hip replacement surgery.	Procedure: Continuous Sacral Erector Spinae Plane Block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Postoperative Mobilization	The duration from the completion of surgery to the patient's first successful achievement of three distinct mobilization milestones: (1) sitting up in bed or chair, (2) standing independently or with minimal assistance, and (3) taking the first steps/walking. Time is recorded in hours. A shorter duration indicates faster functional recovery and earlier ambulation.	Up to 72 hours postoperatively.

Collaborators and Investigators

• Sponsor: Bach Mai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Fascia Iliaca Compartment Block; Sacral Erector Spinae Plane Block; Continuous Analgesia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: SESP-FICB-HIP-RCT-2026; BM-2025-33 (Other Identifier: Institutional Review Board of Bach Mai Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No