NCT07237945

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

November 15, 2025

Last Update Submit

January 31, 2026

Conditions

Keywords

Quadro-Iliac Plane BlockWound InfiltrationQIPB

Outcome Measures

Primary Outcomes (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).

    postoperative day 1

Secondary Outcomes (11)

  • 12-hour cumulative opioid consumption

    postoperative 12th hour

  • Block performance time

    intraoperative period

  • Postoperative pain scores (NRS at rest and activity)

    postoperative day 1

  • Patient-reported quality of recovery (QoR-15 score)

    Postoperative day 1 and at postoperative day 2-4 day

  • Postoperative nausea and vomiting incidence (PONV)

    Postoperative day 1

  • +6 more secondary outcomes

Study Arms (2)

Group QİPB

Patients 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 WI

Patients 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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Contraindications to regional anesthesia
  • Severe psychiatric disorders limiting cooperation (e.g., psychosis, dementia)
  • Pregnancy or breastfeeding
  • Hematologic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk Training and Research Hospital, Department of Anesthesiology and Reanimation

Karabük, 78200, Turkey (Türkiye)

RECRUITING

Study Officials

  • Elif Sarikaya Ozel

    Karabuk Training and Research Hospital, Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Sarikaya Ozel

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 20, 2025

Study Start

December 1, 2025

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations