Perioperative Effects of Lateral Quadratus Lumborum Block in Percutaneous Transhepatic Cholangiography

January 7, 2026 updated by: Seyyid Furkan Kına, Ankara Etlik City Hospital

Perioperative Effects of Lateral Quadratus Lumborum Block in Percutaneous Transhepatic Cholangiography: Prospective Observational Study

The frequency of non-operating room anesthesia (ADA) applications is increasing and has gained an important place in anesthesia practice. Percutaneous transhepatic cholangiography (PTC) procedures applied in interventional radiology are also examples of ADA. It is frequently applied for both diagnostic and therapeutic purposes in cases where obstruction is observed in the bile ducts for any reason. Providing a balanced and comfortable anesthesia during PTC procedures reduces postoperative complications and increases patient and clinician satisfaction. General anesthesia, sedoanesthesia and regional anesthesia can be applied in PTCs. Due to the perioperative complications and undesirable side effects of general anesthesia, it is not the first choice in PTCs. Sedoanesthesia and regional anesthesia are widely applied in PTCs. Postoperative pain is the most important parameter affecting patient satisfaction in this surgery. Inadequate treatment of postoperative pain can reduce the quality of life and cause chronic pain syndromes. In order to effectively combat pain; regional methods are frequently used in addition to intravenous analgesics. For PTC patients, Erector Spinae Plane Block, Quadratus Lumborum Block (QLB) and Subcostal TAP block can be applied covering the T6-L1 dermatome. Since the pain in PTC patients is of visceral and somatic origin, the one with the highest analgesic efficacy is QLB. 4 different techniques of QLB have been defined in the literature and these techniques are; lateral, posterior, anterior transmuscular and intramuscular. Local anesthetic spread is relatively low in the intramuscular technique, while the risk of complications is high in the transmuscular technique. However, lateral and posterior techniques are not superior to each other, and the experience of the clinician is effective in the selection of the technique. The mechanism of action of QLB depends on ipsilateral paravertebral and epidural local anesthetic spread. There are studies in the literature that QLB is used in trunk and abdominal surgeries; provides effective analgesia and reduces the amount of opioid consumed. Due to all these effects, interest in QLB is increasing and its use is becoming widespread. Lateral QLB application: In the left lateral decubitus position, the curvelinear (5-1 MHz) USG probe is placed in the iliac crest and subcostal area at the level of T8-10. Then, the probe is directed posteriorly and cranially to provide detailed visualization of the anterolateral surface of the vertebral body with the transverse process. The probe is slightly tilted to identify the psoas major, quadratus lumborum and erector spinae muscles. The typical image of these 3 muscles forms a three-leaf 'clover' pattern. With the lateral approach, at the point where the transverse abdominis muscle ends, hydrodissection is performed with 2 cc physiological serum to the lateral side of the quadratus lumborum to confirm the location. Then, a total of 20 cc blocking fluid consisting of 14 cc of 0.5% bupivacaine and 6 cc of 2% lidocaine is injected into this area. The blocking fluid is applied in divided doses of 5 cc with intermittent negative aspiration. In our clinic, multimodal anesthesia/analgesia method is preferred in patients undergoing PTC procedure. Peripheral nerve blocks (for all patients who are suitable and accept) are routinely used together with intravenous analgesic agents. The applied block aims to reduce the amount of opioid consumed perioperatively, faster postoperative recovery, lower postoperative VAS scores, lower postoperative analgesia consumption and earlier mobilization. QLB is routinely applied in suitable patients undergoing PTC. Patients who are subjected to sedoanesthesia and those who are subjected to QLB together with sedoanesthesia will be included in the study. The anesthesiologist who provides the anesthesia management of the patients and the anesthesiologist who monitors the patient's pain will be different individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Altındağ, Ankara, Turkey (Türkiye), 06000
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Those between the ages of 18-80
  • Those with ASA score I-II-III
  • Those with body mass index (BMI) between 18-40
  • Patients who underwent sedoanesthesia and sedoanesthesia and QLB for PTC procedure

Exclusion Criteria:

  • Those under 18 and over 80
  • Those with ASA score IV and above
  • Those with advanced co-morbidities
  • Those with a history of bleeding diathesis
  • Patients with an infection in the area where the block will be performed
  • Those with a BMI below 18 and above 40
  • Patients who underwent surgery under emergency conditions
  • Those who are pregnant
  • Those with opioid and local anesthetic allergies-
  • Those with chronic pain syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: group sedation
Preoperatively, 2 mg intravenous midazolam was administered to the patients. Intravenous 0.5 mg/kg propofol and 0.5 mcg/kg fentanyl were used for induction. Intravenous 0.5-1 mg/kg propofol was administered to provide an intraoperative bispectral index of 40-60, and when the Vizel analog score was >4, intravenous 0.1-1 mcg/kg remifentanil was administered. Postoperatively, 1 g paracetamol was routinely administered. When the Vizel analog score was >4, 50 mg dexketoprofen was administered as a rescue analgesic. Postoperative 2nd, 6th, 12th and 24th hour visual analog scores of the patients were recorded.
Procedure: Sedation
Preoperatively, 2 mg intravenous midazolam was administered to the patients. Intravenous 0.5 mg/kg propofol and 0.5 mcg/kg fentanyl were used for induction. Intravenous 0.5-1 mg/kg propofol was administered to provide an intraoperative bispectral index of 40-60, and when the Vizel analog score was >4, intravenous 0.1-1 mcg/kg remifentanil was administered.
Active Comparator: Group sedation+ Quadratus Lumborum Block
Before the procedure, the patient was placed in the left lateral position and a Quadratus Lumborum Block was applied at the thoracic 8-10 level. A total of 20 cc blocking fluid consisting of 14 cc of 0.5% bupivacaine and 6 cc of 2% lidocaine was used for the block. A minimum of 30 minutes was waited after the block. 2 mg of intravenous midazolam was administered before being taken to the operating room. Intravenous 0.5 mg/kg propofol and 0.5 mcg/kg fentanyl were used for induction. Intravenous 0.5-1 mg/kg propofol was administered to provide an intraoperative bispectral index of 40-60, and intravenous 0.1-1 mcg/kg remifentanil was administered when the Vizel analog score was > 4. Postoperatively, 1 g of paracetamol was routinely administered. When the Vizel analog score was > 4, 50 mg of dexketoprofen was administered as a rescue analgesic. Postoperative 2nd, 6th, 12th and 24th hour visual analog scores of the patients were recorded.
Procedure: Sedation + Quadratus Lumborum Block
Before the procedure, the patient was placed in the left lateral position and a Quadratus Lumborum Block was applied at the thoracic 8-10 level. A total of 20 cc blocking fluid consisting of 14 cc of 0.5% bupivacaine and 6 cc of 2% lidocaine was used for the block. A minimum of 30 minutes was waited after the block. 2 mg of intravenous midazolam was administered before being taken to the operating room. Intravenous 0.5 mg/kg propofol and 0.5 mcg/kg fentanyl were used for induction. Intravenous 0.5-1 mg/kg propofol was administered to provide an intraoperative bispectral index of 40-60, and intravenous 0.1-1 mcg/kg remifentanil was administered when the Vizel analog score was >4.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraoperative remifentanil consumption.
Time Frame: Intraoperative period
Intraoperative remifentanil consumption will be recorded.
Intraoperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraoperative propofol consumption.
Time Frame: Intraoperative period
Intraoperative propofol consumption will be recorded.
Intraoperative period
Pain Scores
Time Frame: 24 hours after surgery
Pain will be assessed at rest and coughing using the visual analog scale on a scale form 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 2nd, 6th, 12th, 24th hours after the surgery. Visual analog scale 10 (worst) severe, unbearable pain; 0 (best) no pain.
24 hours after surgery
Postoperative rescue analgesic
Time Frame: During the postoperative 24 hours
atients with a VAS score of 4 and above will receive rescue analgesia.
During the postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Etlik City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seyyid Furkan Kına, MD, Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AEŞH-EK1-2024-0061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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