NCT07487415

Brief Summary

Aim: In this study, we primarily aimed to determine the effect of anterior Quadratus Lumborum Block (QLB) on intraoperative and postoperative opioid consumption in patients undergoing percutaneous nephrolithotomy (PCNL) surgery under general anesthesia. Secondarily, we aimed to evaluate opioid-related complications and investigate the impact of anterior QLB on the quality of postoperative recovery using the QoR-15 (Quality of Recovery-15) questionnaire. Materials and Methods: The study included 60 patients aged 18-75, with ASA physical status I-III, who were scheduled for elective PCNL. Patients were randomly assigned to either the Control Group (n=30) or the Anterior QLB Group (n=30). Following dropouts during follow-up, a total of 54 patients (27 in each group) were analyzed. Preoperative block was performed in the Anterior QLB group. In both groups, following anesthesia induction, anesthesia maintenance was provided with sevoflurane to maintain a BIS value of 40-60, and the remifentanil dosage was adjusted to keep the ANI between 50-70. Operation time, surgical duration, extubation time, intraoperative hemodynamic data, ANI values, and the amount of intraoperative remifentanil consumed were recorded. Postoperative recovery unit pain scores, incidence of nausea and vomiting, and additional analgesic requirements were documented. Pain scores at the 1st, 2nd, 6th, 12th, and 24th postoperative hours, postoperative complications (nausea, vomiting, etc.), opioid consumption, and the results of the QoR-15 questionnaire at the 24th hour were recorded. Results: Intraoperative remifentanil consumption, both in terms of total dose and weight-adjusted infusion rate, was significantly lower in the Anterior QLB group (p\<0.001). Pain scores were significantly lower in the Anterior QLB group both in the recovery unit and at all postoperative time points (p\<0.05). Postoperative cumulative tramadol consumption was also lower in the Anterior QLB group across all time intervals (p\<0.05). No significant difference was found between the two groups regarding the incidence of postoperative nausea and vomiting. Furthermore, no significant difference was observed in the QoR-15 questionnaire scores evaluated at the 24th postoperative hour. Conclusion: Anterior QLB is an effective analgesic method in percutaneous nephrolithotomy surgery, reducing perioperative opioid consumption and postoperative pain scores. It is concluded that anterior QLB is effective as a significant component of the multimodal analgesia strategy by preventing potential side effects associated with opioid consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
Last Updated

March 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

anterior quadratus lumborum blockopioid consumptionpercutaneous nephrolithotomyQuality of Recovery-15

Outcome Measures

Primary Outcomes (1)

  • intraoperative and total postoperative opioid consumption in the first 24 hours

    primary aimed to determine the effect of anterior Quadratus Lumborum Block (QLB) on intraoperative and postoperative opioid consumption in patients undergoing percutaneous nephrolithotomy (PCNL) surgery under general anesthesia.

    first 24 hours after surgery

Secondary Outcomes (2)

  • Quallty of recovery by using QoR-15 questionnaire

    postoperative 24th hour

  • evaluate opioid-related complications

    postoperative 0, 1, 2, 6, 12, 24 th hour

Study Arms (2)

group control

NO INTERVENTION

patients receive standart general anesthesia

group anterior QLB

ACTIVE COMPARATOR

Patients receiving and ultrasound guided anterior quadratus lumborum block in addition to general anesthesia before surgery

Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCK ( anterior QLB)

Interventions

injection local anesthetic between quadratus lumborum and psaos major

group anterior QLB

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 75 years.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Patients undergoing percutaneous nephrolithotomy (PCNL) under general anesthesia

You may not qualify if:

  • Known allergy to local anesthetics.
  • Coagulopathy or bleeding disorders.
  • Infection at the site of intervention.
  • Neurological or neuromuscular diseases.
  • Psychiatric disorders.
  • Chronic pain syndromes.
  • Chronic analgesic or opioid use.
  • History of opioid abuse.
  • Contraindications to regional anesthesia.
  • Cardiac dysrhythmia that could interfere with Analgesia Nociception Index (ANI) monitoring.
  • Patients requiring vasoactive or chronotropic drugs (e.g., atropine, ephedrine, nitroglycerin, or noradrenaline) to maintain hemodynamic stability during surgery.
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Hospital

Zonguldak, Zonguldak Province, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

May 1, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

March 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations