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
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Bach Mai Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Cumulative Opioid Consumption at 24 Hours Postoperatively
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: Continuous Sacral Erector Spinae Plane Block (Procedure)
Continuous FICB
Patients in this arm will receive an ultrasound-guided continuous Fascia Iliaca Compartment Block (FICB) for postoperative analgesia following hip replacement surgery.
Intervention: Continuous Fascia Iliaca Compartment Block (Procedure)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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)
Investigators
Nguyen Toan Thang
Head of Anesthesiology and Intensive Care Department
Bach Mai Hospital