Opioid ConsumptionNCT06618781
Perioperative Effects of Lateral Quadratus Lumborum Block in Percutaneous Transhepatic Cholangiography
A study testing Sedation and Sedation + Quadratus Lumborum Block in people with Opioid Consumption and Visual Analog Score, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid Consumption, Visual Analog Score, Demographic Data
- What is being tested?
- Sedation and Sedation + Quadratus Lumborum Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2024to 25 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Patients who underwent surgery under emergency conditions
- Those who are pregnant
- Those with opioid and local anesthetic allergies-
- Those with chronic pain syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Altındağ, Ankara, 06000
About this study
Official title: 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.
- Conditions
- Opioid Consumption, Visual Analog Score, Demographic Data, Rescue Analgesic Status and Time
- Being tested
- Sedation, Sedation + Quadratus Lumborum Block
- Keywords
- Percutaneous transhepatic cholangiography, Quadratus lumborum block, Interventional Radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedationProcedure or surgery
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.
Sedation + Quadratus Lumborum BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| group sedation | Active comparator | 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. Receives: Procedure: Sedation |
| Group sedation+ Quadratus Lumborum Block | Active comparator | 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. Receives: Procedure: Sedation + Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption.
Intraoperative remifentanil consumption will be recorded.
Measured: Intraoperative period
Secondary outcomes (3)
Intraoperative propofol consumption.
Intraoperative propofol consumption will be recorded.
Measured: Intraoperative period
Pain Scores
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.
Measured: 24 hours after surgery
Postoperative rescue analgesic
atients with a VAS score of 4 and above will receive rescue analgesia.
Measured: During the postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start11 Oct 2024
- Primary completion29 Dec 2024
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid ConsumptionStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seyyid Furkan Kına, Ankara Etlik City Hospital
- Investigators
- Seyyid Furkan Kına, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618781
- Sponsor's protocol ID
- AEŞH-EK1-2024-0061
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kina SF, Yazar CO, Cataroglu CK, Tangobay E, Uyanik SA, Altinsoy S, Polat R, Ergil J. Perioperative effects of the quadratus lumborum block in percutaneous biliary drainage: a prospective randomized controlled study. Turk J Med Sci. 2026 Jun 1;56(4):1074-1084. doi: 10.55730/1300-0144.6351. eCollection 2026.
PubMed 42677258
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Effects of Lateral Quadratus Lumborum Block in Percutaneous Transhepatic Cholangiography: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06618781
- Acronym / sponsor ID
- AEŞH-EK1-2024-0061
- Conditions
- Opioid Consumption, Visual Analog Score, Demographic Data, Rescue Analgesic Status and Time
- Keywords
- Percutaneous transhepatic cholangiography, Quadratus lumborum block, Interventional Radiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group sedation | Active comparator | Procedure: SedationPreoperatively, 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. |
| Group sedation+ Quadratus Lumborum Block | Active comparator | Procedure: Sedation + Quadratus Lumborum BlockBefore 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SedationPreoperatively, 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. | Procedure or surgery | group sedation |
| Sedation + Quadratus Lumborum BlockBefore 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. | Procedure or surgery | Group sedation+ Quadratus Lumborum Block |
Primary outcome
Intraoperative remifentanil consumption.
Time frame: Intraoperative period
Intraoperative remifentanil consumption will be recorded.
3 secondary outcomes
Intraoperative propofol consumption.
Time frame: Intraoperative period
Pain Scores
Time frame: 24 hours after surgery
Postoperative rescue analgesic
Time frame: During the postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 42677258Kina SF, Yazar CO, Cataroglu CK, Tangobay E, Uyanik SA, Altinsoy S, Polat R, Ergil J. Perioperative effects of the quadratus lumborum block in percutaneous biliary drainage: a prospective randomized controlled study. Turk J Med Sci. 2026 Jun 1;56(4):1074-1084. doi: 10.55730/1300-0144.6351. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyyid Furkan Kına, MD principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation and Sedation + Quadratus Lumborum Block in people with Opioid Consumption and Visual Analog Score, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative remifentanil consumption. (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06618781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.