Analgesic Efficacy of Continuous SESP vs Continuous FICB After Hip Arthroplasty

NCT07516795 | Active Not Recruiting

• 2 other identifiers: SESP-FICB-HIP-RCT-2026BM-2025-33
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Anesthesia, Regional; Arthroplasty, Replacement, Hip

Keywords

Sacral Erector Spinae Plane Block; Fascia Iliaca Compartment Block; Regional Anesthesia; Continuous Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cumulative MME Consumption at 24 Hours and 48 Hours Postoperatively

  0-24 h and 24-48 h after block placement

• Pain Intensity at Rest (VAS)

  0 to 72 hours after block placement

• Pain Intensity During Movement (VAS)

  0 to 72 hours after block placement

• Quality of Recovery-15 (QoR-15) Score at 72 Hours

  72 hours after block placement

• Motor Function (Modified Bromage Scale)

  24 and 72 hours after block placement

Study Arms (2)

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.

Procedure: Continuous Sacral Erector Spinae Plane Block

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.

Procedure: Continuous Fascia Iliaca Compartment Block

Interventions

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.

Also known as: Continuous Sacral ESP Block, Continuous Sacral ESPB

Continuous SESP

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.

Also known as: Continuous Fascia Iliaca Block, Continuous FICB, Continuous Fascia Iliaca Compartment Block (CFICB)

Continuous FICB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bach Mai Hospital: lead

Study Sites (1)

Bach Mai Hospital

Hanoi, Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology and Intensive Care Department

Model Details: Eligible patients are randomly assigned to one of two parallel groups (SESP or FICB) in a 1:1 ratio.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

VN (1)