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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Sedation and Sedation + Quadratus Lumborum Block
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06618781
Study groupRoleWhat they receive
group sedationActive comparatorPreoperatively, 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 BlockActive comparatorBefore 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.

  1. Intraoperative remifentanil consumption.

    Intraoperative remifentanil consumption will be recorded.

    Measured: Intraoperative period

Secondary outcomes (3)
  1. Intraoperative propofol consumption.

    Intraoperative propofol consumption will be recorded.

    Measured: Intraoperative period

  2. 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

  3. 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.

  1. First posted1 Oct 2024
  2. Study start11 Oct 2024
  3. Primary completion29 Dec 2024
  4. Study completion25 Feb 2025

Resources

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)
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

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.

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