- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07516795
Analgesic Efficacy of Continuous S-ESP vs Continuous FICB After Hip Arthroplasty (SESP-HIP)
Comparison of the Analgesic Efficacy of Continuous Sacral Erector Spinae Plane Block (S-ESP) and Continuous Fascia Iliaca Compartment Block (FICB) After Hip Replacement Surgery: A Randomized Controlled Trial
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.
Study Overview
Status
Detailed Description
Effective postoperative pain management is crucial for early rehabilitation, patient satisfaction, and enhanced recovery after hip replacement surgery. While the continuous Fascia Iliaca Compartment Block (FICB) is a well-established and widely used regional anesthesia technique for hip surgery, it is frequently associated with quadriceps weakness, which can significantly delay early ambulation and physical therapy.
The continuous Sacral Erector Spinae Plane (S-ESP) block is a relatively novel, ultrasound-guided fascial plane block that targets the lumbar and sacral plexus branches. Recent literature suggests it offers profound sensory blockade with relative motor sparing, making it a highly attractive alternative for lower extremity surgeries.
In this study, eligible patients scheduled for elective unilateral hip replacement surgery at Bach Mai Hospital will be randomly allocated into two parallel arms: the S-ESP group and the FICB group. Under ultrasound guidance, a catheter will be inserted into the respective fascial plane (sacral erector spinae plane or fascia iliaca compartment). A continuous infusion of local anesthetic will be administered via the catheter for 48 hours postoperatively.
Both groups will receive a standardized multimodal systemic analgesia protocol. Rescue analgesia (intravenous opioids) will be provided on demand. A blinded outcome assessor will meticulously record static and dynamic pain scores, cumulative opioid consumption, the degree of motor blockade, time to first ambulation, and any procedure-related adverse events. The findings of this study will help determine if continuous S-ESP is a more optimal regional anesthesia strategy compared to the traditional continuous FICB for postoperative pain control in hip arthroplasty.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hanoi
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Hanoi, Hanoi, Vietnam, 100000
- Bach Mai hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Continuous S-ESP
Patients in this arm will receive an ultrasound-guided continuous Sacral Erector Spinae Plane (S-ESP) block for postoperative analgesia following hip replacement surgery.
|
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:
|
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative Opioid Consumption at 24 Hours Postoperatively
Time Frame: During the first 24,48,72 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity at Rest
Time Frame: At 2, 6, 12, 24, 48, 36 and 72 hours postoperatively.
|
Pain intensity at rest assessed using the Visual Analog Scale (VAS).
The VAS is an 11-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst imaginable pain."
A higher score indicates greater pain severity.
|
At 2, 6, 12, 24, 48, 36 and 72 hours postoperatively.
|
|
Postoperative Pain Intensity During Movement
Time Frame: At 2, 6, 12, 24, 48, 36 and 72 hours postoperatively
|
Pain intensity during passive or active movement (e.g., hip flexion) assessed using the Visual Analog Scale (VAS).
The VAS is an 11-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst imaginable pain."
A higher score indicates greater pain severity.
|
At 2, 6, 12, 24, 48, 36 and 72 hours postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Postoperative Mobilization
Time Frame: Up to 72 hours postoperatively.
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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