Postoperative PainNCT07904585
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
A study testing Quadro-Iliac Plane Block (QIPB) and Erector Spinae Plane Block in people with Postoperative Pain and Hip Arthroplasty, Total, run by Uludag University.
Trial summary
This prospective, single-center, randomized controlled, double-blind (participant and outcomes assessor) trial compares ultrasound-guided erector spinae plane block (ESPB) and quadro-iliac plane block (QIPB) in adult patients undergoing elective primary unilateral total hip arthroplasty (THA) under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Hip Arthroplasty, Total
- What is being tested?
- Quadro-Iliac Plane Block (QIPB) and Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Scheduled for elective primary unilateral total hip arthroplasty
- Provided written informed consent
- American Society of Anesthesiologists (ASA) physical status I, II or III
- Aged 18-80 years
- Scheduled to undergo surgery under spinal anesthesia
- Able to understand the information provided in Turkish and have the cognitive capacity to complete the QoR-15 questionnaire
Who cannot join
- Contraindication to regional anesthesia (coagulopathy, inappropriate anticoagulant use, infection at the injection site, etc.)
- History of known allergy or severe adverse reaction to local anesthetics
- Chronic opioid use, opioid dependence, or history of substance abuse
- Advanced cognitive impairment, inability to give valid consent, or inability to complete the questionnaires
- Pregnancy or breastfeeding
- Need for emergency surgery
Show all 12Show fewer
- Surgical plan extending beyond unilateral primary total hip arthroplasty (THA)
- Presence of a severe systemic disease (severe neurological disease; advanced-stage hepatic, renal or cardiovascular failure) or clinical condition that may prevent adherence to the study protocol
- Body mass index (BMI) > 35 kg/m²
- Contraindication or allergy to the multimodal analgesic agents specified in the protocol (paracetamol, NSAIDs, dexamethasone) or to morphine
- Regular gabapentinoid use or chronic pain syndrome
- Inability to use the patient-controlled analgesia (PCA) device
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This prospective, single-center, randomized controlled, double-blind (participant and outcomes assessor) trial compares ultrasound-guided erector spinae plane block (ESPB) and quadro-iliac plane block (QIPB) in adult patients undergoing elective primary unilateral total hip arthroplasty (THA) under spinal anesthesia. Eighty patients will be randomized 1:1 to receive either block in addition to a standardized multimodal analgesia protocol. The primary outcome is cumulative opioid consumption (intravenous morphine equivalents, mg) during the first 24 postoperative hours. Secondary outcomes include quality of recovery (QoR-15), pain scores, opioid consumption at later time points, quadriceps strength, mobilization, patient satisfaction, and safety outcomes. It is hypothesized that QIPB will reduce 24-hour opioid consumption more than ESPB.
Read the detailed description
Rationale: Fascial plane blocks combined with spinal anesthesia are an important component of multimodal analgesia after total hip arthroplasty. ESPB has shown analgesic efficacy after THA in randomized trials. QIPB, described in 2024, may reach the lumbar plexus branches that contribute to hip innervation more consistently. To the investigators' knowledge, the two blocks have not been directly compared in THA.
Design: Prospective, single-center, randomized, double-blind (participant and outcomes assessor), parallel two-arm trial. Eighty adults (40 per group) undergoing elective primary unilateral THA under spinal anesthesia are allocated 1:1 (blocks of four, sealed opaque envelopes) to ultrasound-guided QIPB or ESPB, each with 30 mL of 0.25% bupivacaine, performed before incision. All patients receive standardized multimodal analgesia (dexamethasone, paracetamol, tenoxicam) and morphine patient-controlled analgesia (PCA) for rescue.
Assessments: Opioid consumption (PCA records, converted to IV morphine equivalents), NRS pain scores at rest and with movement, quadriceps strength, QoR-15 (preoperatively and at 24 hours), mobilization, satisfaction and adverse events are recorded for 48 hours. Postoperative hour 0 is the end of surgery.
Sample size and analysis: 37 patients per group are needed to detect an effect size of about 0.66 (alpha 0.05, two-sided, 80% power; G*Power 3.1.9.7); 40 per group are enrolled to allow for data loss. The primary analysis (modified intention-to-treat) uses the independent samples t-test or Mann-Whitney U test with the effect size and 95% confidence interval; repeated NRS scores are analyzed with a linear mixed-effects model, and secondary outcomes are exploratory. Analyses are performed with IBM SPSS Statistics.
Safety and oversight: The total bupivacaine dose will not exceed 2.5 mg/kg, and lipid emulsion is available in the operating room. Serious adverse events are reported to the ethics committee. A qualified person or team appointed by the principal investigator monitors the study. Participant data are coded and protected under the Turkish Personal Data Protection Law (No. 6698). The study is academic, with no external funding.
- Conditions
- Postoperative Pain, Hip Arthroplasty, Total
- Being tested
- Quadro-Iliac Plane Block (QIPB), Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane Block, Quadro-Iliac Plane Block, Total Hip Arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadro-Iliac Plane Block (QIPB)Procedure or surgery
Spinal anesthesia, then single-shot ultrasound-guided fascial plane block performed at the level of the iliac crest in the posterior plane of the quadratus lumborum muscle, with injection of 30 mL of 0.25% bupivacaine. Standard multimodal analgesia and morphine patient-controlled analgesia (PCA) are provided postoperatively.
Erector Spinae Plane BlockProcedure or surgery
Spinal anesthesia, then single-shot ultrasound-guided lumbar erector spinae plane block targeting the L3 vertebral level, with injection of 30 mL of 0.25% bupivacaine. Standard multimodal analgesia and morphine PCA are provided postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Quadro-Iliac Plane Block (QIPB) | Experimental | Not described Receives: Procedure: Quadro-Iliac Plane Block (QIPB) |
| Erector Spinae Plane Block (ESPB) | Active comparator | Not described Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption in the first 24 postoperative hours
Total opioid consumption (PCA and additional rescue morphine), determined from PCA device records and converted to intravenous morphine equivalents (mg).
Measured: First 24 hours after surgery
Secondary outcomes (4)
Quality of Recovery-15 (QoR-15) score
The Quality of Recovery-15 (QoR-15) is a validated patient-reported measure of the quality of recovery after surgery and anesthesia. It has 15 items, each scored from 0 to 10, giving a total score of 0 to 150; higher scores indicate better recovery. The items cover five dimensions: physical comfort, physical independence, psychological support, emotional state and pain, and negative items are reverse-scored. Total scores are commonly interpreted as excellent (136-150), good (122-135), moderate (90-121) or poor (0-89). The validated Turkish version is used. It is administered preoperatively (baseline) and at postoperative hour 24; the outcome is the total score at hour 24 and its change from the preoperative baseline value.
Measured: Postoperative 24th hour
Pain intensity at rest (Numeric Rating Scale, NRS)
The Numeric Rating Scale (NRS) is a validated, self-reported measure of pain intensity. Patients rate their pain on an 11-point scale from 0 (no pain) to 10 (unbearable pain); higher scores indicate more severe pain. Pain at rest is recorded at each time point listed in the time frame.
Measured: PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48
Pain intensity with movement (Numeric Rating Scale, NRS)
The Numeric Rating Scale (NRS) is a validated, self-reported measure of pain intensity. Patients rate their pain on an 11-point scale from 0 (no pain) to 10 (unbearable pain); higher scores indicate more severe pain. Pain with movement is assessed during passive 45-degree flexion of the operated hip at each time point listed in the time frame.
Measured: PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48
Time to first rescue analgesia
Time from the end of surgery to the first PCA request.
Measured: First 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcan Akesen, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904585
- Sponsor's protocol ID
- 2026-10/15
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07904585
- Acronym / sponsor ID
- 2026-10/15
- Conditions
- Postoperative Pain, Hip Arthroplasty, Total
- Keywords
- Erector Spinae Plane Block, Quadro-Iliac Plane Block, Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 Oct 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.
This prospective, single-center, randomized controlled, double-blind (participant and outcomes assessor) trial compares ultrasound-guided erector spinae plane block (ESPB) and quadro-iliac plane block (QIPB) in adult patients undergoing elective primary unilateral total hip arthroplasty (THA) under spinal anesthesia. Eighty patients will be randomized 1:1 to receive either block in addition to a standardized multimodal analgesia protocol. The primary outcome is cumulative opioid consumption (intravenous morphine equivalents, mg) during the first 24 postoperative hours. Secondary outcomes include quality of recovery (QoR-15), pain scores, opioid consumption at later time points, quadriceps strength, mobilization, patient satisfaction, and safety outcomes. It is hypothesized that QIPB will reduce 24-hour opioid consumption more than ESPB.
Detailed description
Rationale: Fascial plane blocks combined with spinal anesthesia are an important component of multimodal analgesia after total hip arthroplasty. ESPB has shown analgesic efficacy after THA in randomized trials. QIPB, described in 2024, may reach the lumbar plexus branches that contribute to hip innervation more consistently. To the investigators' knowledge, the two blocks have not been directly compared in THA.
Design: Prospective, single-center, randomized, double-blind (participant and outcomes assessor), parallel two-arm trial. Eighty adults (40 per group) undergoing elective primary unilateral THA under spinal anesthesia are allocated 1:1 (blocks of four, sealed opaque envelopes) to ultrasound-guided QIPB or ESPB, each with 30 mL of 0.25% bupivacaine, performed before incision. All patients receive standardized multimodal analgesia (dexamethasone, paracetamol, tenoxicam) and morphine patient-controlled analgesia (PCA) for rescue.
Assessments: Opioid consumption (PCA records, converted to IV morphine equivalents), NRS pain scores at rest and with movement, quadriceps strength, QoR-15 (preoperatively and at 24 hours), mobilization, satisfaction and adverse events are recorded for 48 hours. Postoperative hour 0 is the end of surgery.
Sample size and analysis: 37 patients per group are needed to detect an effect size of about 0.66 (alpha 0.05, two-sided, 80% power; G*Power 3.1.9.7); 40 per group are enrolled to allow for data loss. The primary analysis (modified intention-to-treat) uses the independent samples t-test or Mann-Whitney U test with the effect size and 95% confidence interval; repeated NRS scores are analyzed with a linear mixed-effects model, and secondary outcomes are exploratory. Analyses are performed with IBM SPSS Statistics.
Safety and oversight: The total bupivacaine dose will not exceed 2.5 mg/kg, and lipid emulsion is available in the operating room. Serious adverse events are reported to the ethics committee. A qualified person or team appointed by the principal investigator monitors the study. Participant data are coded and protected under the Turkish Personal Data Protection Law (No. 6698). The study is academic, with no external funding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadro-Iliac Plane Block (QIPB) | Experimental | Procedure: Quadro-Iliac Plane Block (QIPB) |
| Erector Spinae Plane Block (ESPB) | Active comparator | Procedure: Erector Spinae Plane Block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled for elective primary unilateral total hip arthroplasty
- Provided written informed consent
- American Society of Anesthesiologists (ASA) physical status I, II or III
- Aged 18-80 years
- Scheduled to undergo surgery under spinal anesthesia
Key exclusion criteria (12 listed)
- Contraindication to regional anesthesia (coagulopathy, inappropriate anticoagulant use, infection at the injection site, etc.)
- History of known allergy or severe adverse reaction to local anesthetics
- Chronic opioid use, opioid dependence, or history of substance abuse
- Advanced cognitive impairment, inability to give valid consent, or inability to complete the questionnaires
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Quadro-Iliac Plane Block (QIPB)Spinal anesthesia, then single-shot ultrasound-guided fascial plane block performed at the level of the iliac crest in the posterior plane of the quadratus lumborum muscle, with injection of 30 mL of 0.25% bupivacaine. Standard multimodal analgesia and morphine patient-controlled analgesia (PCA) are provided postoperatively. | Procedure or surgery | Quadro-Iliac Plane Block (QIPB) |
| Erector Spinae Plane BlockSpinal anesthesia, then single-shot ultrasound-guided lumbar erector spinae plane block targeting the L3 vertebral level, with injection of 30 mL of 0.25% bupivacaine. Standard multimodal analgesia and morphine PCA are provided postoperatively. | Procedure or surgery | Erector Spinae Plane Block (ESPB) |
Primary outcome
Cumulative opioid consumption in the first 24 postoperative hours
Time frame: First 24 hours after surgery
Total opioid consumption (PCA and additional rescue morphine), determined from PCA device records and converted to intravenous morphine equivalents (mg).
4 secondary outcomes
Quality of Recovery-15 (QoR-15) score
Time frame: Postoperative 24th hour
Pain intensity at rest (Numeric Rating Scale, NRS)
Time frame: PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48
Pain intensity with movement (Numeric Rating Scale, NRS)
Time frame: PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48
Time to first rescue analgesia
Time frame: First 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Quadro-Iliac Plane Block (QIPB) and Erector Spinae Plane Block in people with Postoperative Pain and Hip Arthroplasty, Total, run by Uludag University.
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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selcan Akesen (+902242953274, selcanakesen@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption in the first 24 postoperative hours (time frame: First 24 hours after surgery). 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 3 Nov 2026.