Pain, Postoperative; Anesthesia, RegionalSESP-HIPNCT07516795
Analgesic Efficacy of Continuous SESP vs Continuous FICB After Hip Arthroplasty
A study testing Continuous Sacral Erector Spinae Plane Block and Continuous Fascia Iliaca Compartment Block in people with Pain, Postoperative; Anesthesia, Regional and Arthroplasty, Replacement, Hip, run by Bach Mai Hospital at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative; Anesthesia, Regional, Arthroplasty, Replacement, Hip
- What is being tested?
- Continuous Sacral Erector Spinae Plane Block and Continuous Fascia Iliaca Compartment Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 9 Apr 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Numeric Rating Scale (NRS) and follow-up evaluations.
- Provided written informed consent to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 30 mL 0.1% ropivacaine followed by intermittent boluses of 20 mL 0.1% 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 (NRS), 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.
Read the 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 30 mL 0.1% ropivacaine followed by intermittent boluses of 20 mL 0.1% ropivacaine every 6 hours for a total of 72 hours via the indwelling catheter. All patients receive standardized multimodal analgesia consisting of intravenous paracetamol 1 g every 8 h and diclofenac 75 mg every 12 h, 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 NRS 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 the incidence of adverse events. Catheter boluses were administered every 6 h by the anaesthesiologists who performed the blocks, who were necessarily unblinded and collected no outcome data. Outcome assessors, the ward nurses administering multimodal analgesia and managing the PCA devices, and data analysts remained blinded to group allocation. Patients could not be blinded due to the distinct anatomical locations of the two interventions.
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.
- Being tested
- Continuous Sacral Erector Spinae Plane Block, Continuous Fascia Iliaca Compartment Block
- Keywords
- Sacral Erector Spinae Plane Block, Fascia Iliaca Compartment Block, Regional Anesthesia, Continuous Analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Sacral Erector Spinae Plane BlockProcedure or surgery
Also called Continuous Sacral ESP Block, Continuous Sacral ESPB
Under ultrasound guidance, a catheter is inserted into the sacral erector spinae plane. An initial bolus of 30 mL of 0.1% ropivacaine is injected at catheter placement, followed by intermittent boluses of 20 mL of 0.1% ropivacaine every 6 hours for 72 hours via the indwelling catheter.
Continuous Fascia Iliaca Compartment BlockProcedure or surgery
Also called Continuous Fascia Iliaca Block, Continuous FICB, Continuous Fascia Iliaca Compartment Block (CFICB)
Under ultrasound guidance, a catheter is inserted deep to the fascia iliaca. An initial bolus of 30 mL of 0.1% ropivacaine is injected at catheter placement, followed by intermittent boluses of 20 mL of 0.1% ropivacaine every 6 hours for 72 hours via the indwelling catheter.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Continuous Fascia Iliaca Compartment Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 72 hours after block placement
Secondary outcomes (6)
Cumulative MME Consumption at 24 Hours and 48 Hours Postoperatively
Total rescue opioid consumption (MME) during 0-24 h and 24-48 h intervals.
Measured: 0-24 h and 24-48 h after block placement
Pain scores at rest (NRS)
Pain scores at rest assessed using 0-10 NRS at 0, 2, 6, 12, 24, 36, 48, and 72 hours after block placement.
Measured: 0 to 72 hours after block placement
Pain Intensity During Movement (NRS)
Pain scores during hip flexion (active movement) assessed using 0-10 NRS at the same time points.
Measured: 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.
Measured: 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 hours after block placement.
Measured: 24 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.
Measured: 0 to 72 hours after block placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start9 Apr 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Postoperative; Anesthesia, RegionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients are randomly assigned to one of two parallel groups (SESP or FICB) in a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bach Mai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Toan Thang, Bach Mai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516795
- Sponsor's protocol ID
- SESP-FICB-HIP-RCT-2026
- Other IDs
- BM-2025-33
- Acronym
- SESP-HIP
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Sacral Erector Spinae Plane Block Versus Continuous Fascia Iliaca Compartment Block for Postoperative Analgesia After Total Hip Arthroplasty: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07516795
- Acronym / sponsor ID
- SESP-HIP / SESP-FICB-HIP-RCT-2026
- Keywords
- Sacral Erector Spinae Plane Block, Fascia Iliaca Compartment Block, Regional Anesthesia, Continuous Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bach Mai HospitalUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 30 mL 0.1% ropivacaine followed by intermittent boluses of 20 mL 0.1% 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 (NRS), 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.
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 30 mL 0.1% ropivacaine followed by intermittent boluses of 20 mL 0.1% ropivacaine every 6 hours for a total of 72 hours via the indwelling catheter. All patients receive standardized multimodal analgesia consisting of intravenous paracetamol 1 g every 8 h and diclofenac 75 mg every 12 h, 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 NRS 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 the incidence of adverse events. Catheter boluses were administered every 6 h by the anaesthesiologists who performed the blocks, who were necessarily unblinded and collected no outcome data. Outcome assessors, the ward nurses administering multimodal analgesia and managing the PCA devices, and data analysts remained blinded to group allocation. Patients could not be blinded due to the distinct anatomical locations of the two interventions.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients are randomly assigned to one of two parallel groups (SESP or FICB) in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Continuous SESP | Experimental | Procedure: Continuous Sacral Erector Spinae Plane BlockPatients in this arm will receive an ultrasound-guided continuous Sacral Erector Spinae Plane (SESP) block for postoperative analgesia following hip replacement surgery. |
| Continuous FICB | Active comparator | Procedure: Continuous Fascia Iliaca Compartment BlockPatients in this arm will receive an ultrasound-guided continuous Fascia Iliaca Compartment Block (FICB) for postoperative analgesia following hip replacement surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 Numeric Rating Scale (NRS) and follow-up evaluations.
- Provided written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Sacral Erector Spinae Plane BlockAlso: Continuous Sacral ESP Block, Continuous Sacral ESPBUnder ultrasound guidance, a catheter is inserted into the sacral erector spinae plane. An initial bolus of 30 mL of 0.1% ropivacaine is injected at catheter placement, followed by intermittent boluses of 20 mL of 0.1% ropivacaine every 6 hours for 72 hours via the indwelling catheter. | Procedure or surgery | Continuous SESP |
| Continuous Fascia Iliaca Compartment BlockAlso: Continuous Fascia Iliaca Block, Continuous FICB, Continuous Fascia Iliaca Compartment Block (CFICB)Under ultrasound guidance, a catheter is inserted deep to the fascia iliaca. An initial bolus of 30 mL of 0.1% ropivacaine is injected at catheter placement, followed by intermittent boluses of 20 mL of 0.1% ropivacaine every 6 hours for 72 hours via the indwelling catheter. | Procedure or surgery | Continuous FICB |
Primary outcome
Cumulative Morphine Milligram Equivalents (MME) Consumption at 72 Hours Postoperatively
Time frame: 0 to 72 hours after block placement
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.
6 secondary outcomes
Cumulative MME Consumption at 24 Hours and 48 Hours Postoperatively
Time frame: 0-24 h and 24-48 h after block placement
Pain scores at rest (NRS)
Time frame: 0 to 72 hours after block placement
Pain Intensity During Movement (NRS)
Time frame: 0 to 72 hours after block placement
Quality of Recovery-15 (QoR-15) Score at 72 Hours
Time frame: 72 hours after block placement
Motor Function (Modified Bromage Scale)
Time frame: 24 hours after block placement
Incidence of Adverse Events
Time frame: 0 to 72 hours after block placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Sacral Erector Spinae Plane Block and Continuous Fascia Iliaca Compartment Block in people with Pain, Postoperative; Anesthesia, Regional and Arthroplasty, Replacement, Hip, run by Bach Mai Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Morphine Milligram Equivalents (MME) Consumption at 72 Hours Postoperatively (time frame: 0 to 72 hours after block placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.