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).
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
- Conditions the study is for
- Postoperative Pain Management, Lumbar Discectomy, Regional Anaesthesia
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Block performance time
Total time (minutes) required to complete the QIPB procedure.
Measured: intraoperative period
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
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
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
Time to first PCA analgesic demand
Time at which the first analgesic is requested
Measured: Postoperative day 1
Number of patients requiring rescue analgesia
Number of patients who required rescue analgesia despite PCA use.
Measured: Postoperative day 1
Time to first mobilization
Time (hours) from the end of surgery to first assisted ambulation with a physiotherapist.
Measured: Postoperative day 2-4
Block-related complications
Incidence of complications such as bleeding, hematoma, or local anesthetic systemic toxicity (LAST).
Measured: Postoperative day 7
Opioid-related adverse effects
Presence of itching, sedation, fatigue, or respiratory depression related to opioid use.
Measured: Postoperative day 7
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.
- First posted20 Nov 2025
- Study start1 Dec 2025
- Primary completion24 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elif Sarikaya Ozel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elif Sarikaya Ozel, Karabuk University
- Investigators
- Elif Sarikaya Ozel, Principal investigator, Karabuk Training and Research Hospital, Department of Anesthesiology
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Quadro-Iliac Plane Block and Wound Infiltration on Postoperative Acute Pain After Single-Level Lumbar Discectomy Surgery
- ClinicalTrials.gov ID
- NCT07237945
- Acronym / sponsor ID
- QIPB-LD2026
- Keywords
- Quadro-Iliac Plane Block, Wound Infiltration, QIPB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Elif Sarikaya OzelUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 20 Nov 2025 (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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
24-hour cumulative opioid consumption
Time frame: postoperative day 1
Total opioid consumption within the first 24 hours, including PCA-administered morphine and rescue analgesics converted to morphine milligram equivalents (MME).
11 secondary outcomes
12-hour cumulative opioid consumption
Time frame: postoperative 12th hour
Block performance time
Time frame: intraoperative period
Postoperative pain scores (NRS at rest and activity)
Time frame: postoperative day 1
Patient-reported quality of recovery (QoR-15 score)
Time frame: Postoperative day 1 and at postoperative day 2-4 day
Postoperative nausea and vomiting incidence (PONV)
Time frame: Postoperative day 1
Time to first PCA analgesic demand
Time frame: Postoperative day 1
Number of patients requiring rescue analgesia
Time frame: Postoperative day 1
Time to first mobilization
Time frame: Postoperative day 2-4
Block-related complications
Time frame: Postoperative day 7
Opioid-related adverse effects
Time frame: Postoperative day 7
Length of hospital stay
Time frame: Postoperative day 2-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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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. This study is not recruiting at the moment.
Elif Sarikaya Ozel principal investigator
Karabuk Training and Research Hospital, Department of Anesthesiology
1 site in 1 country: see every site and its status.
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.