NCT07695987

Brief Summary

This study will evaluate whether ultrasound-guided quadro-iliac plane block provides better postoperative pain control than local infiltration analgesia in patients undergoing single-level lumbar microdiscectomy. Adult patients scheduled for elective single-level lumbar microdiscectomy will be randomly assigned to receive either bilateral quadro-iliac plane block plus patient-controlled analgesia or local infiltration analgesia plus patient-controlled analgesia. The main outcome of the study will be total fentanyl consumption during the first 24 hours after surgery. Pain scores, need for rescue analgesia, opioid-related side effects, patient satisfaction, and recovery quality will also be evaluated.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

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

Study Progress15%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2026

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 6, 2026

Last Update Submit

July 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Fentanyl Consumption During the First 24 Hours After Surgery

    Total postoperative fentanyl consumption administered via patient-controlled analgesia will be recorded during the first 24 hours after surgery.

    Postoperative 0-24 hours

Secondary Outcomes (5)

  • Postoperative Pain Scores at Rest and During Movement

    Postoperative 0, 1, 6, 12, and 24 hours

  • Number of Patients Require Rescue Analgesic

    Postoperative 0-24 hours

  • Opioid-Related Adverse Effects

    Postoperative 0-24 hours

  • Quality of Recovery Score

    Postoperative 24 hours

  • Dermatomal Sensory Spread

    Postoperative 2 hours

Study Arms (2)

Quadro-Iliac Plane Block Group

ACTIVE COMPARATOR

Participants in this group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from general anesthesia, followed by postoperative fentanyl-based patient-controlled analgesia.

Procedure: Ultrasound-Guided Quadro-Iliac Plane Block

Local Infiltration Analgesia Group

ACTIVE COMPARATOR

Participants in this group will receive surgeon-performed local infiltration analgesia, followed by postoperative fentanyl-based patient-controlled analgesia.

Procedure: Local Infiltration Analgesia (LIA)

Interventions

Local infiltration analgesia will be performed by the surgeon before the end of surgery. A total dose of 50 mg of 0.25% bupivacaine will be infiltrated into the subcutaneous tissue. All participants will receive postoperative fentanyl-based patient-controlled analgesia.

Local Infiltration Analgesia Group

Bilateral ultrasound-guided quadro-iliac plane block will be performed before emergence from general anesthesia in the prone position. After visualization of the quadratus lumborum muscle and iliac crest at the L3 level, 30 mL of 0.167% bupivacaine will be injected into the interfascial plane on each side. All participants will receive postoperative fentanyl-based patient-controlled analgesia.

Quadro-Iliac Plane Block Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 75 years
  • American Society of Anesthesiologists physical status I to III
  • Scheduled for elective single-level lumbar microdiscectomy, such as L4-L5 or L5-S1 disc herniation
  • Planned surgery under general anesthesia
  • Able to provide written informed consent

You may not qualify if:

  • Allergy or hypersensitivity to local anesthetics
  • Coagulopathy or active anticoagulant use
  • Infection, scar tissue, or skin lesion at the injection site
  • Pregnancy or breastfeeding
  • Chronic pain syndrome or regular opioid use
  • American Society of Anesthesiologists physical status IV or higher
  • Planned surgery for two or more levels of disc herniation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Engin ihsan Turan, principal investigator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and the postoperative outcomes assessor will be blinded to group allocation. The anesthesiologist performing the block procedure will not take part in postoperative data collection or outcome assessment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

July 10, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 2, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations