Analgesic Efficacy of Continuous S-ESP 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, double-blind controlled trial is to compare the postoperative analgesic efficacy of continuous Sacral Erector Spinae Plane (S-ESP) block versus continuous Fascia Iliaca Compartment Block (FICB) in adult patients undergoing elective hip replacement surgery. The investigators hypothesize that the continuous S-ESP block will provide non-inferior or superior pain relief compared to continuous FICB, while potentially reducing the incidence of motor block and facilitating earlier postoperative mobilization. Participants will be randomly assigned to receive either an S-ESP or FICB catheter for continuous local anesthetic infusion over 48 hours postoperatively. Postoperative pain scores, opioid consumption, and functional recovery will be systematically evaluated.

Conditions

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

Keywords

Sacral Erector Spinae Plane Block; S-ESP; Fascia Iliaca Compartment Block; FICB; Regional Anesthesia; Continuous Analgesia

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Consumption at 24 Hours Postoperatively

  The total amount of rescue opioid analgesics administered to the patient, converted to intravenous morphine milligram equivalents (MME). A higher value represents a worse outcome (greater need for rescue analgesia).

  During the first 24,48,72 hours postoperatively

Secondary Outcomes (2)

• Postoperative Pain Intensity at Rest

  At 2, 6, 12, 24, 48, 36 and 72 hours postoperatively.

• Postoperative Pain Intensity During Movement

  At 2, 6, 12, 24, 48, 36 and 72 hours postoperatively

Other Outcomes (1)

• Time to First Postoperative Mobilization

  Up to 72 hours postoperatively.

Study Arms (2)

Continuous S-ESP

EXPERIMENTAL

Patients in this arm will receive an ultrasound-guided continuous Sacral Erector Spinae Plane (S-ESP) 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 S-ESP

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

You may qualify if:

• Adult patients aged 18 to 100 years.
• Scheduled for elective unilateral hip replacement surgery.
• American Society of Anesthesiologists (ASA) physical status I, II, or III.
• Ability to communicate effectively and understand the pain scale (VAS).
• Provided written informed consent.

You may not qualify if:

• Patient refusal to participate in the study.
• Contraindications to regional anesthesia (e.g., coagulopathy, therapeutic anticoagulation, or local infection at the injection site).
• Known allergy or hypersensitivity to local anesthetics (e.g., Ropivacaine, Bupivacaine).

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist performing the ultrasound-guided block cannot be blinded to the group allocation. However, the patients, the ward nurses (care providers), and the independent outcome assessors who record postoperative pain scores and opioid consumption are strictly blinded to the group assignment.
• 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 (S-ESP or FICB) in a 1:1 ratio.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: September 25, 2025
• Primary Completion: May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

VN (1)