An interventional study of Quadro-iliac plane block in Inguinal Hernia Unilateral, Postoperative Pain and Opioid Use, sponsored by Marmara University Pendik Training and Research Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Marmara University Pendik Training and Research Hospital · Not applicable, Interventional, and Prevention
The goal of this randomized controlled trial is to learn whether an ultrasound-guided quadro-iliac plane block (QIPB) reduces opioid use and pain after laparoscopic inguinal hernia repair in adults aged 18-65 years. The main question it aims to answer is: does QIPB reduce total tramadol consumption during the first 24 postoperative hours? Researchers will compare patients who receive QIPB under general anesthesia with patients who receive no block. All participants will receive the same general anesthesia, multimodal analgesia and intravenous tramadol patient-controlled analgesia (PCA). Pain scores, PCA use, quality of recovery (QoR-15), nausea and vomiting, and time to discharge will be recorded during the first 24 hours.
Laparoscopic inguinal hernia repair (TAPP or TEP) causes less pain than open repair, but many patients still report moderate to severe pain in the early postoperative period, with both somatic and visceral components. The quadro-iliac plane block is a recently described fascial plane block in which local anesthetic is injected between the inner surface of the iliac crest and the posterior surface of the quadratus lumborum muscle. Cadaveric data show spread to the ilioinguinal, iliohypogastric, subcostal and genitofemoral nerves and the lumbar plexus, and case series suggest effective analgesia after inguinal hernia surgery.
This single-center, prospective, randomized, controlled, outcome-assessor-blinded trial will be conducted at Marmara University Pendik Training and Research Hospital. Sixty-four patients will be randomized 1:1 by computer-generated random numbers to Group QIPB or Group C (control). The anesthesia team will know the group allocation; the investigator assessing outcomes will be blinded.
All patients will receive standard monitoring (ECG, non-invasive blood pressure, SpO2, EtCO2, bispectral index) and IV midazolam 0.02 mg/kg premedication. Anesthesia will be induced with remifentanil 2 µg/kg, propofol 2-2.5 mg/kg and rocuronium 0.6 mg/kg, and maintained with desflurane and remifentanil infusion, targeting BIS 40-60. In Group QIPB, after induction and in the lateral position, a unilateral QIPB will be performed on the surgical side with a low-frequency convex probe placed parasagittally at the attachment of the quadratus lumborum to the iliac crest. Using an in-plane approach with a 100-mm block needle, needle position will be confirmed with 5 mL saline, followed by 40 mL of 0.25% bupivacaine with intermittent aspiration. Group C will receive no block.
Fifteen minutes before the end of surgery, all patients will receive IV paracetamol 1 g, tramadol 1.5 mg/kg and ondansetron 8 mg. After surgery, all patients will receive IV tramadol PCA (10 mg/mL; 1 mL bolus; 10-minute lockout). Patients with NRS > 4 will receive rescue IV morphine 4 mg. Pain scores at rest and on coughing and cumulative tramadol consumption will be recorded at 0, 6, 12 and 24 hours. The QoR-15 questionnaire will be administered preoperatively (baseline) and at 24 hours.
The sample size was calculated using G*Power 3.1. Assuming a mean 24-hour tramadol consumption of 85 mg in the control group, a minimum clinically relevant reduction of 25 mg (approx. 30%) and an SD of 30 mg (Cohen's d = 0.83), with α = 0.05 and power = 0.80, 24 patients per group are required. To allow for dropouts and protocol violations, 32 patients per group (64 in total) will be enrolled. Data will be analyzed using the independent-samples t-test or Mann-Whitney U test, repeated-measures ANOVA or linear mixed-effects models for pain scores over time, Kaplan-Meier analysis with the log-rank test for time to first PCA demand, chi-square or Fisher's exact test for categorical outcomes, and ANCOVA adjusted for baseline QoR-15. A two-sided p \< 0.05 will be considered statistically significant.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 64 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Marmara University Pendik Training and Research Hospital is the lead sponsor of 34 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Unilateral ultrasound-guided quadro-iliac plane block on the surgical side after induction of general anesthesia (40 mL 0.25% bupivacaine), plus standard multimodal analgesia and IV tramadol PCA.
Procedure: Quadro-iliac plane block
No block. Standard general anesthesia, multimodal analgesia and IV tramadol PCA only.
With the patient in the lateral position, a low-frequency convex probe is placed parasagittally at the attachment of the quadratus lumborum to the iliac crest. Using an in-plane approach with a 100-mm block needle, position is confirmed with 5 mL saline, followed by 40 mL of 0.25% bupivacaine.
Total tramadol consumption
Cumulative tramadol (mg) delivered by the IV PCA device during the first 24 postoperative hours
Time frame: 0-24 hours after surgery
Pain score at rest
Numeric Rating Scale (NRS), 0 = no pain, 10 = worst imaginable pain
Time frame: 0, 6, 12 and 24 hours after surgery
Pain score on coughing
NRS (0-10) during coughing
Time frame: 0, 6, 12 and 24 hours after surgery
Time to first PCA demand
Time (minutes) from arrival in the PACU to the first patient-activated PCA bolus
Time frame: Up to 24 hours after surgery
Quality of recovery
QoR-15 total score (0-150; higher = better recovery), adjusted for preoperative baseline QoR-15
Time frame: Preoperatively (baseline) and 24 hours after surgery
Postoperative nausea and vomiting
Incidence and severity (0 = none, 1 = mild nausea, 2 = severe nausea, 3 = vomiting); need for additional antiemetics
Time frame: 0, 6, 12 and 24 hours after surgery
Intraoperative remifentanil consumption
Total remifentanil dose (µg) during anesthesia
Time frame: Intraoperative
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Of 1,888 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 10 months is close to that.
Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
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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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Marmara University Pendik Training and Research Hospital