- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07487415
Anterior QLB for PCNL
Perioperative Analgesia Management in Patients Undergoing Percutaneous Nephrolithotomy Following Anterior Quadratus Lumborum Block
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zonguldak Province
-
Zonguldak, Zonguldak Province, Turkey (Türkiye)
- Zonguldak Bulent Ecevit University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 75 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients undergoing percutaneous nephrolithotomy (PCNL) under general anesthesia
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: group control
patients receive standart general anesthesia
|
|
|
Active Comparator: group anterior QLB
Patients receiving and ultrasound guided anterior quadratus lumborum block in addition to general anesthesia before surgery
|
injection local anesthetic between quadratus lumborum and psaos major
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intraoperative and total postoperative opioid consumption in the first 24 hours
Time Frame: first 24 hours after surgery
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quallty of recovery by using QoR-15 questionnaire
Time Frame: postoperative 24th hour
|
postoperative 24th hour
|
|
evaluate opioid-related complications
Time Frame: postoperative 0, 1, 2, 6, 12, 24 th hour
|
postoperative 0, 1, 2, 6, 12, 24 th hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024/08-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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