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Uterine BleedingNCT07046949

Anterior Quadratus Lumborum Block as a Component of Multimodal Analgesia for Abdominal Hysterectomies

A study testing ANTERİOR QUADRATUS LUMBORUM BLOCK, Parenteral administration of analgesics and General Anesthesia (GA) in people with Uterine Bleeding and Uterine Neoplasms, run by Yuri Semenyuk Rivne Regional Clinical Hospital at 1 site in Ukraine.

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 main goal of this randomised double-blinded controlled trial is to assess whether adding anterior quadratus lumborum block preoperatively can reduce intraoperative and postoperative opioid consumption, reduce pain after abdominal hysterectomy and improve quality of recovery after anesthesia. Read more about this study

Who is it for?
Ages 40 to 55 years, women only
What is being tested?
ANTERİOR QUADRATUS LUMBORUM BLOCK, Parenteral administration of analgesics and General Anesthesia (GA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUkraine
Study dates
7 Jul 2025to 11 Dec 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 40 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • patients with ASA status I-II
  • patients with symptomatic fibroids
  • patients scheduled for abdominl hysterectomy

Who cannot join

  • refusal to participate in the study at any of its stages
  • ASA class ≥ III
  • body mass index > 40 kg/m2
  • use of opiate receptor agonists/antagonists before surgery
  • uncontrolled hypertension

Trial locations and contacts

1 site in 1 country.

Ukraine1 site
  • Yuri Semenyuk Rivne regional cinical hospital

    Rivne, Rivne Oblast, 33007

Other trials in Ukraine

About this study

Official title: A Randomized Controlled Double-blinded Trial Evaluating the Efficacy of the Anterior Quadratus Lumborum Block as a Component of Multimodal Perioperative Analgesia for Abdominal Hysterectomies

The main goal of this randomised double-blinded controlled trial is to assess whether adding anterior quadratus lumborum block preoperatively can reduce intraoperative and postoperative opioid consumption, reduce pain after abdominal hysterectomy and improve quality of recovery after anesthesia. The study hypothesis is that anterior QL block bilaterally before the start of a surgery has no impact on perioperative pain relief, can't reduce the need in opioids and will not improve quality of recovery after anesthesia.

All patients will undergo general anesthesia with tracheal intubation and mechanical ventilation. Patients will be randomized into two groups. In addition to general anesthesia and multimodal analgesia with parenteral medication II (QL) group will receive also anterior quadratus lumborum block as a regional component.

Read the detailed description

Primary outcomes : intraoperative fentanyl consumption, daily requirement of morphine and pain level (with visual analogue scale - VAS) after surgery. Secondary outcomes: quality of recovery after anesthesia (with QoR-15 questionnaire), heart rate perioperatively, mean arterial pressure perioperatively, incidence of postoperative nausea.

Thromboprophylaxis will be administered based on the risk of thromboembolic complications for all patients. In the operative room all patients will receive ondansetron, dexamethasone and tranexamic acid. Patients will be told that they will receive multimodal analgesia but they won't know if they get a regional component (quadratus lumborum block). The randomisation will take place in the operative room. After general anesthesia induction and endotracheal intubation attending anesthesiologist will leave the operative room and anesthesiologist-resident will perform randomization and QL-block or won't perform QL-block. Thus participants and attending anesthesiologist won't know the randomisation result. In our study attending anaesthesiologist will be the researcher who will collect and analyse data. After the intubation patients of the control group will receive acetaminophen 1000 mg, dexketoprofen 50 mg before incision and MgSO4 1250 mg with ongoing continuous infusion of MgSO4 2500 mg per hour. In addition to these analgesia regimen patients in the II (QL) group will receive bilateral ultrasound-navigated anterior quadratus lumborum block before the start of the surgery. The investigators will use a convex low-frequency transducer with a frequency of 1.5-5 Mhz (General Electric Logiq e ultrasound machine). The block will be performed in the patient's spine position. Investigators choose anterior approach hypothesizing its superiority over other approaches to quadratus lumborum block. After proper visualization and obtaining an adequate sonographic image, the 22g needle will be inserted through the lateral abdominal wall and will be advanced through the skin, subcutaneous fat tissue, external oblique muscle, internal oblique muscle, aponeurosis of the transverse abdominis muscle, then it will be advanced through the quadratus lumborum muscle and operator will reach thoracolumbar fascia, between the quadratus lumborum muscle and the psoas major muscle. In this localization anesthesiologist-resident will inject a local anesthetic. Operator will use 20 ml of 0,25% bupivacaine with 4 mg of dexamethasone as adjuvant for one side, all blocks will be performed bilaterally only. General anaesthesia will be maintained by continuous propofol infusion with target effect site concentration 3-3,5 mcg/ml, atracurium infusion with target effect site concentration 900 ng/ml and bolus fentanyl injections to maintain target effect site concentration 2-4 ng/ml. All target concentrations will be calculated via ITIVA version 6.3.2 software. Attending anesthesiologist will modify the dosage of anesthetic drugs, particularly fentanyl, reducing them if necessary. At postoperative stage for patients of both groups investigators plan to administer multimodal analgesia: dexketoprofen (150 mg/day), acetaminophene (4000 mg/day). In addition, in the case of severe pain - morphine will be added (5-20 mg/day).

Mechanical ventilation will be performed in pressure-regulated volume control ventilation mode counting tidal volume 6 ml/kg (Getinge Flow-e anesthesia machine). Intraoperatively attending anesthesiologist will count the fentanyl consumption considering that the length of the surgeries will not have significant differences.

At the end of the surgery investigators will count total amount of administered fentanyl, evaluate heart rate and mean arterial pressure.

After the end of the surgeries patients will be extubated and transferred to the postoperative ward. After the surgery investigators are planning to evaluate morphine consumption, level of pain according to the visual analogue scale (VAS), quality of recovery after anesthesia (with QoR-15 questionnaire), heart rate, mean arterial pressure, incidences of nausea.

Being tested
ANTERİOR QUADRATUS LUMBORUM BLOCK, Parenteral administration of analgesics, General Anesthesia (GA)
Keywords
Regional anesthesia, Quadratus lumborum block, Abdominal hysterectomy, Pain scores, Multimodal analgesia, Acute pain, Chronic pain, Pain management, Opioid consumption, Quality of recovery, Postoperative nausea and vomiting, General anesthesia, Blended anesthesia, Hemodynamics after surgery
Medical subject headings
Uterine Hemorrhage, Uterine Neoplasms, Uterine Diseases, Leiomyoma, Acute Pain, Chronic Pain, Agnosia, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANTERİOR QUADRATUS LUMBORUM BLOCKProcedure or surgery

    Ultrasound-guided anterior QL block performed preoperatively

  • Parenteral administration of analgesicsDrug

    Intravenous opioids or NSAIDs used perioperatively.

  • General Anesthesia (GA)Procedure or surgery

    Standard general anesthesia per continious 1% propofol infusion and propofol bolus administration, atracurium and fentanyl administration.

Study groups in NCT07046949
Study groupRoleWhat they receive
Group I (control)Active comparatorPatients in Group I will undergo general anesthesia with tracheal intubation and mechanical ventilation. Analgesia regimen will include parenteral medication.
Receives: Drug: Parenteral administration of analgesics; Procedure: General Anesthesia (GA)
Group II (QL)ExperimentalPatients in Group II (QL) will undergo general anesthesia with tracheal intubation and mechanical ventilation. Analgesia regimen will include parenteral medication and anterior quadratus lumborum block as a regional component.
Receives: Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCK; Drug: Parenteral administration of analgesics; Procedure: General Anesthesia (GA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain level after surgery

    It will be tested using visual analogue scale (VAS)

    Measured: It will be checked at the folowing stages of the study: 30 minutes (m30) 6 hours (h6), 12 hours (h12), 24 hours (h24), 48 hours (h48) after the end of the surgery.

  2. Requirement of morphine for 24 hours

    The investigators will count a dose of morphine administered for patients of both groups postoperatively

    Measured: 24 hours (h24), 48 hours (h48) after the surgery

  3. Intraoperative fentanyl consumption

    The investigators will compare fentanyl consumption between two groups, considering that the duration of surgeries differences won't be statistically significant.

    Measured: Intraoperative stage, at the end of the surgery (h0)

Secondary outcomes (4)
  1. Quality of recovery after anesthesia

    The investigators will measure it using QoR-15 questionnaire

    Measured: The investigators will test it in 24 hours after the end of the surgery (h24)

  2. Postoperative nausea

    The investigators will define the incidents of nausea in both groups after the surgery

    Measured: At 30 minutes (m30), 6 hours (h6), 12 hours (h12), 24 hours (h24) after the end of the surgery

  3. Perioperative heart rate

    The investigators will evaluate heart rate during the surgery and after it will be finished.

    Measured: The investigators will evaluate parameters at intraoperative stage (h0), 30 minutes (m30), 6 hours (h6), 12 hours (h12), 24 hours (h24), 48 hours (h48) after the surgery.

  4. Mean arterial pressure perioperatively

    The investigators will evaluate mean arterial pressure during the surgery and after it will be finished.

    Measured: The investigators will evaluate the parameters at intraoperative stage (h0), 30 minutes (m30), 6 hours (h6), 12 hours (h12), 24 hours (h24), 48 hours (h48) after the surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study start7 Jul 2025
  3. Primary completion8 Dec 2025
  4. Study completion11 Dec 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
Model description
A two-arm parallel group design in which participants are randomly allocated to receive either general anesthesia and multimodal analgesia without QL-block or general anesthesia and multimodal analgesia including QL-block.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07046949
Sponsor's protocol ID
7-A/2812
Status last verified
Nov 2025
First submitted
29 May 2025
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD used in the results publication will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing ANTERİOR QUADRATUS LUMBORUM BLOCK, Parenteral administration of analgesics and General Anesthesia (GA) in people with Uterine Bleeding and Uterine Neoplasms, run by Yuri Semenyuk Rivne Regional Clinical Hospital at 1 site in Ukraine.

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 3 inclusion and 5 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 16 Dec 2025. 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 Ukraine. 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?

Pain level after surgery (time frame: It will be checked at the folowing stages of the study: 30 minutes (m30) 6 hours (h6), 12 hours (h12), 24 hours (h24), 48 hours (h48) after the end of the surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 Dec 2025.

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