- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06618781
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative remifentanil consumption.
Time Frame: Intraoperative period
|
Intraoperative remifentanil consumption will be recorded.
|
Intraoperative period
|
Secondary Outcome Measures
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
Investigators
- 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)
October 11, 2024
Primary Completion (Actual)
December 29, 2024
Study Completion (Actual)
February 25, 2025
Study Registration Dates
First Submitted
September 26, 2024
First Submitted That Met QC Criteria
September 26, 2024
First Posted (Actual)
October 1, 2024
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID 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
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