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Postoperative Pain ManagementNCT07237945

Quadro-Iliac Plane Block Versus Wound Infiltration for Postoperative Pain After Single-Level Lumbar Discectomy

An observational study of Postoperative Pain Management and Lumbar Discectomy, run by Elif Sarikaya Ozel at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective observational study aims to compare the effects of the Quadro-Iliac Plane Block (QIPB) and wound infiltration (WI) on postoperative acute pain in adult patients undergoing elective single-level lumbar discectomy. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 1 May 2026
Phase
Observational
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

Study population: Adult patients scheduled to undergo elective single-level lumbar discectomy at Karabuk Training and Research Hospital. Eligible participants will be evaluated preoperatively and enrolled prospectively according to predefined inclusion and exclusion criteria. No healthy volunteers are included.

Who may be able to join

  • Adults aged 18 to 80 years
  • Scheduled for elective single-level lumbar discectomy
  • ASA physical status I-III
  • Able to use patient-controlled analgesia (PCA)
  • Able and willing to provide written informed consent

Who cannot join

  • History of opioid use for longer than 4 weeks
  • Presence of chronic pain before surgery (e.g., migraine, fibromyalgia)
  • Alcohol or substance dependence
  • Known allergy or hypersensitivity to local anesthetics or opioids
  • Significant organ dysfunction (e.g., severe hepatic or renal disease)
  • Revision or multilevel spine surgery
Show all 10Show fewer
  • Contraindications to regional anesthesia
  • Severe psychiatric disorders limiting cooperation (e.g., psychosis, dementia)
  • Pregnancy or breastfeeding
  • Hematologic disorders

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Karabuk Training and Research Hospital, Department of Anesthesiology and Reanimation

    Karabük, 78200

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Quadro-Iliac Plane Block and Wound Infiltration on Postoperative Acute Pain After Single-Level Lumbar Discectomy Surgery

This prospective observational study aims to compare the effects of the Quadro-Iliac Plane Block (QIPB) and wound infiltration (WI) on postoperative acute pain in adult patients undergoing elective single-level lumbar discectomy. QIPB is a newly introduced ultrasound-guided fascial plane block, and it is currently being used in routine clinical practice in our anesthesiology department as part of postoperative analgesia for lumbar spine surgery. Wound infiltration is a conventional method in which local anesthetic is injected into the surgical field at the end of the procedure.

In this study, eligible patients will be monitored prospectively without randomization or alteration of standard care. Postoperative pain scores, opioid consumption, nausea and vomiting, patient satisfaction, and recovery parameters will be evaluated during the first 24 hours after surgery. The study aims to provide real-world clinical evidence comparing these two analgesic techniques in lumbar discectomy patients.

Read the detailed description

This prospective observational study aims to evaluate and compare the postoperative analgesic outcomes of two routinely used analgesic techniques-Quadro-Iliac Plane Block (QIPB) and wound infiltration (WI)-in adult patients undergoing elective single-level lumbar discectomy. Both QIPB and WI are standard components of postoperative pain management in our hospital, and the type of analgesic technique administered to each patient is determined solely by the attending anesthesiologist based on routine clinical judgment. The research team does not influence clinical decision-making, perform block procedures, or modify any aspect of patient care. All interventions included in this study reflect standard institutional practice.

The primary objective is to compare cumulative opioid consumption during the first 24 hours after surgery between patients receiving QIPB and those receiving WI. Secondary objectives include evaluating postoperative pain scores, early recovery parameters, patient satisfaction, postoperative nausea and vomiting (PONV), rescue analgesic requirements, block-related complications, and hospital length of stay.

Clinical Routine and Analgesic Protocol

All patients will be managed according to the standard multimodal analgesia protocol routinely used in our neurosurgery operating room. Intraoperatively, intravenous tenoxicam 20 mg, tramadol 100 mg and dexamethasone 8 mg will be administered as part of routine analgesic and antiemetic care. Paracetamol 1 g IV will be given at the end of surgery and continued at regular intervals postoperatively. Rescue analgesia will consist of intravenous tramadol 100 mg infused over 30 minutes, with a maximum daily dose of 300 mg; if pain remains uncontrolled (NRS ≥4). All patients will receive intravenous morphine patient-controlled analgesia (Body Guard 575 Pain Manager) with a standard setting of 1 mg bolus dose, a 10-minute lockout interval, and a 4-hour limit set to 80% of the maximum allowable dose.

Block Techniques (Performed as Part of Routine Care)

QIPB Group:

QIPB is a newly introduced interfascial block technique currently used in our clinic for postoperative lumbar spine analgesia. At the end of surgery and before extubation, the patient is placed in the prone position. A low-frequency convex ultrasound probe (2-6 MHz) is positioned at the L3 midline in the transverse plane to identify the spinous process. The probe is then moved laterally and caudally to visualize the attachment of the quadratus lumborum muscle to the iliac crest. Under ultrasound guidance, a 22G, 100-mm block needle is advanced into the fascial plane between the quadratus lumborum and erector spinae muscles. A total of 60 mL of 0.25% bupivacaine (30 mL per side) is injected bilaterally. The procedure is performed by experienced anesthesiologists as part of normal clinical practice.

Wound Infiltration Group (WI):

WI is a routine analgesic method performed in our operating room. At the end of surgery, before skin closure, 20 mL of 0.25% bupivacaine is infiltrated into the surgical field in multiple tissue layers. This procedure is performed entirely according to the attending anesthesiologist's habitual clinical practice.

Postoperative Assessment

Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS; 0-10) at rest and during movement (deep breathing or coughing) at 0, 3, 6, 12, and 24 hours after surgery. PONV will be evaluated using a verbal descriptive scale. If PONV score is ≥3, 4 mg IV ondansetron will be administered. Patient satisfaction and quality of recovery will be assessed using the Turkish version of the QoR-15 questionnaire preoperatively, on postoperative day 1, and at discharge.

Block-related complications (hematoma, bleeding at the injection site, LAST), opioid-related side effects (itching, sedation, respiratory depression), time to first PCA demand, time to first mobilization, rescue analgesic requirements, and hospital length of stay will be recorded.

All data will be analyzed using SPSS software. Statistical tests will be selected based on data distribution, and a p-value < 0.05 will be considered statistically significant.

Keywords
Quadro-Iliac Plane Block, Wound Infiltration, QIPB

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07237945
Study groupRoleWhat they receive
Group QİPBPatients receiving ultrasound-guided Quadro-Iliac Plane Block with 30 mL of 0.25% bupivacaine per side (total 60 mL) as part of routine postoperative analgesia after single-level lumbar discectomy.
Group WIPatients receiving ultrasound-guided wound infiltration with 20 mL of 0.25% bupivacaine into the surgical field at the end of surgery as part of routine postoperative analgesia after single-level lumbar discectomy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-hour cumulative opioid consumption

    Total opioid consumption within the first 24 hours, including PCA-administered morphine and rescue analgesics converted to morphine milligram equivalents (MME).

    Measured: postoperative day 1

Secondary outcomes (11)
  1. 12-hour cumulative opioid consumption

    Total opioid consumption within the first 12 hours, including PCA-administered morphine and rescue analgesics converted to MME.

    Measured: postoperative 12th hour

  2. Block performance time

    Total time (minutes) required to complete the QIPB procedure.

    Measured: intraoperative period

  3. Postoperative pain scores (NRS at rest and activity)

    Pain status at rest and while activity will be assessed by numeric rating scale (NRS) score at 0, 3, 6, 12, 18 and 24 hours after surgery. In addition, the time until the first analgesic requirement will be recorded. The NRS is an 11-point numeric scale that ranges from 0 to 10.

    Measured: postoperative day 1

  4. Patient-reported quality of recovery (QoR-15 score)

    Quality of recovery assessed using the validated 15-item QoR-15 questionnaire.

    Measured: Postoperative day 1 and at postoperative day 2-4 day

  5. Postoperative nausea and vomiting incidence (PONV)

    The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18 and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required (The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once).

    Measured: Postoperative day 1

  6. Time to first PCA analgesic demand

    Time at which the first analgesic is requested

    Measured: Postoperative day 1

  7. Number of patients requiring rescue analgesia

    Number of patients who required rescue analgesia despite PCA use.

    Measured: Postoperative day 1

  8. Time to first mobilization

    Time (hours) from the end of surgery to first assisted ambulation with a physiotherapist.

    Measured: Postoperative day 2-4

  9. Block-related complications

    Incidence of complications such as bleeding, hematoma, or local anesthetic systemic toxicity (LAST).

    Measured: Postoperative day 7

  10. Opioid-related adverse effects

    Presence of itching, sedation, fatigue, or respiratory depression related to opioid use.

    Measured: Postoperative day 7

  11. Length of hospital stay

    Duration of hospitalization measured in hours or days.

    Measured: Postoperative day 2-4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completion24 Apr 2026
  4. Study completion1 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07237945
Sponsor's protocol ID
QIPB-LD2026
Status last verified
May 2026
First submitted
15 Nov 2025
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain Management and Lumbar Discectomy, run by Elif Sarikaya Ozel at 1 site in Turkey (Türkiye).

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 5 inclusion and 10 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 15 May 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 Turkey (Türkiye). 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?

24-hour cumulative opioid consumption (time frame: postoperative day 1). 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 15 May 2026.

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