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Not yet recruitingNCT07904585Updated Nov 3, 2026

Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty

An interventional study of Quadro-Iliac Plane Block (QIPB) and Erector Spinae Plane Block in Postoperative Pain and Hip Arthroplasty, Total, sponsored by Uludag University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Uludag University · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Start date movedPrimary completion moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Postoperative Pain
  • Hip Arthroplasty, Total

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Keywords

  • Erector Spinae Plane Block
  • Quadro-Iliac Plane Block
  • Total Hip Arthroplasty
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Uludag University is the lead sponsor of 149 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Scheduled for elective primary unilateral total hip arthroplasty
  • Provided written
  • (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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
  • (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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Quadro-Iliac Plane Block (QIPB)

    Procedure: Quadro-Iliac Plane Block (QIPB)

  • Active comparator
    Erector Spinae Plane Block (ESPB)

    Procedure: Erector Spinae Plane Block

Interventions

  • ProcedureQuadro-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.

  • ProcedureErector Spinae Plane Block

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: First 24 hours after surgery

Secondary outcomes

  1. 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.

    Time frame: Postoperative 24th hour

  2. 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.

    Time frame: PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48

  3. 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.

    Time frame: PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48

  4. Time to first rescue analgesia

    Time from the end of surgery to the first PCA request.

    Time frame: First 48 hours after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 12 months is close to that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

Completion moved once since we started tracking on Sep 25, 2026: Nov 2027 → Oct 2027, on Nov 3, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 29, 2026
StartEst.
Oct 31, 2026
Primary completionEst.
Oct 31, 2027
CompletionEst.
Oct 31, 2027was Nov 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 26, 2026→Oct 31, 2026
Nov 3, 2026
Primary completion
Oct 26, 2027→Oct 31, 2027
Nov 3, 2026
Study completion
Nov 26, 2027→Oct 31, 2027
Nov 3, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionCumulative opioid consumption in the first 24 postoperative hours: how it is measured was reworded
Nov 3, 2026
Secondary outcomes
3 time frame changed, 1 added, 3 description edited
What changed in the outcomes
  • AddedTime to first rescue analgesiaTime frame: First 48 hours after surgery
  • Time frameQuality of Recovery-15 (QoR-15) scorepostoperative 24th hour → Postoperative 24th hour
  • Time framePain intensity at rest (Numeric Rating Scale, NRS)First 48 hours after surgery → PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48
  • Time framePain intensity with movement (Numeric Rating Scale, NRS)First 48 hours after surgery → PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48
  • DescriptionPain intensity at rest (Numeric Rating Scale, NRS): how it is measured was reworded
  • DescriptionPain intensity with movement (Numeric Rating Scale, NRS): how it is measured was reworded
  • DescriptionQuality of Recovery-15 (QoR-15) score: how it is measured was reworded
Nov 3, 2026
Registered
First appeared on the registry
Oct 29, 2026
Show all 2 updates
  1. Nov 3, 2026
    Start date Oct 26, 2026→Oct 31, 2026
    Primary completion Oct 26, 2027→Oct 31, 2027
    Study completion Nov 26, 2027→Oct 31, 2027
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionCumulative opioid consumption in the first 24 postoperative hours: how it is measured was reworded
    Secondary outcomes 3 time frame changed, 1 added, 3 description edited
    What changed in the outcomes
    • AddedTime to first rescue analgesiaTime frame: First 48 hours after surgery
    • Time frameQuality of Recovery-15 (QoR-15) scorepostoperative 24th hour → Postoperative 24th hour
    • Time framePain intensity at rest (Numeric Rating Scale, NRS)First 48 hours after surgery → PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48
    • Time framePain intensity with movement (Numeric Rating Scale, NRS)First 48 hours after surgery → PACU arrival and postoperative hours 2, 6, 12, 24, 36 and 48
    • DescriptionPain intensity at rest (Numeric Rating Scale, NRS): how it is measured was reworded
    • DescriptionPain intensity with movement (Numeric Rating Scale, NRS): how it is measured was reworded
    • DescriptionQuality of Recovery-15 (QoR-15) score: how it is measured was reworded
  2. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07904585
Lead sponsor
Uludag University
Responsible party
Selcan Akesen (Medical Doctor, Uludag University) — Principal investigator
First posted
Oct 29, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Selcan Akesen
Contact
selcanakesen@uludag.edu.tr
+902242953274

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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