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.
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
- Conditions the study is for
- Uterine Bleeding, Uterine Neoplasms, Uterine Diseases
- What is being tested?
- ANTERİOR QUADRATUS LUMBORUM BLOCK, Parenteral administration of analgesics and General Anesthesia (GA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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 group | Role | What they receive |
|---|---|---|
| Group I (control) | Active comparator | Patients 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) | Experimental | Patients 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.
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.
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
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)
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)
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
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.
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.
- First posted2 Jul 2025
- Study start7 Jul 2025
- Primary completion8 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine BleedingStudies of the same condition, open and under way.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Yuri Semenyuk Rivne Regional Clinical Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danylo Halytsky Lviv National Medical University
- Responsible party
- Sponsor
- Investigators
- Olha Filyk, Professor, Study chair, Danylo Halytsky Lviv National Medical University
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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07046949
- Acronym / sponsor ID
- 7-A/2812
- Keywords
- Regional anesthesia, Quadratus lumborum block, Abdominal hysterectomy, Pain scores, Multimodal analgesia, Acute pain, Chronic pain, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yuri Semenyuk Rivne Regional Clinical HospitalUniversity, hospital or other
- Collaborators
- Danylo Halytsky Lviv National Medical University
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 2 Jul 2025 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group I (control) | Active comparator | Drug: Parenteral administration of analgesics, Procedure: General Anesthesia (GA)Patients in Group I will undergo general anesthesia with tracheal intubation and mechanical ventilation. Analgesia regimen will include parenteral medication. |
| Group II (QL) | Experimental | Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCK, Drug: Parenteral administration of analgesics, Procedure: General Anesthesia (GA)Patients 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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with ASA status I-II
- patients with symptomatic fibroids
- patients scheduled for abdominl hysterectomy
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ANTERİOR QUADRATUS LUMBORUM BLOCKUltrasound-guided anterior QL block performed preoperatively | Procedure or surgery | Group II (QL) |
| Parenteral administration of analgesicsIntravenous opioids or NSAIDs used perioperatively. | Drug | Group I (control), Group II (QL) |
| General Anesthesia (GA)Standard general anesthesia per continious 1% propofol infusion and propofol bolus administration, atracurium and fentanyl administration. | Procedure or surgery | Group I (control), Group II (QL) |
Primary outcome
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.
It will be tested using visual analogue scale (VAS)
Requirement of morphine for 24 hours
Time frame: 24 hours (h24), 48 hours (h48) after the surgery
The investigators will count a dose of morphine administered for patients of both groups postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperative stage, at the end of the surgery (h0)
The investigators will compare fentanyl consumption between two groups, considering that the duration of surgeries differences won't be statistically significant.
4 secondary outcomes
Quality of recovery after anesthesia
Time frame: The investigators will test it in 24 hours after the end of the surgery (h24)
Postoperative nausea
Time frame: At 30 minutes (m30), 6 hours (h6), 12 hours (h12), 24 hours (h24) after the end of the surgery
Perioperative heart rate
Time frame: 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.
Mean arterial pressure perioperatively
Time frame: 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.
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 16 Dec 2025.
- Individual participant dataSharing planned: Yes. IPD used in the results publication will be shared.
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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.
Olha Filyk, Professor study chair
Danylo Halytsky Lviv National Medical University
1 site in 1 country: see every site and its status.
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.