- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07046949
- Original Trial
Anterior Quadratus Lumborum Block as a Component of Multimodal Analgesia for Abdominal Hysterectomies
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rivne Oblast
-
Rivne, Rivne Oblast, Ukraine, 33007
- Yuri Semenyuk Rivne regional cinical hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients with ASA status I-II
- patients with symptomatic fibroids
- patients scheduled for abdominl hysterectomy
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group I (control)
Patients in Group I will undergo general anesthesia with tracheal intubation and mechanical ventilation.
Analgesia regimen will include parenteral medication.
|
Intravenous opioids or NSAIDs used perioperatively.
Standard general anesthesia per continious 1% propofol infusion and propofol bolus administration, atracurium and fentanyl administration.
|
|
Experimental: Group II (QL)
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.
|
Intravenous opioids or NSAIDs used perioperatively.
Standard general anesthesia per continious 1% propofol infusion and propofol bolus administration, atracurium and fentanyl administration.
Ultrasound-guided anterior QL block performed preoperatively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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
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
|
24 hours (h24), 48 hours (h48) after the surgery
|
|
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.
|
Intraoperative stage, at the end of the surgery (h0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of recovery after anesthesia
Time Frame: The investigators will test it in 24 hours after the end of the surgery (h24)
|
The investigators will measure it using QoR-15 questionnaire
|
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
|
The investigators will define the incidents of nausea in both groups after the surgery
|
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.
|
The investigators will evaluate heart rate during the surgery and after it will be finished.
|
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.
|
The investigators will evaluate mean arterial pressure during the surgery and after it will be finished.
|
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.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Olha Filyk, Professor, Danylo Halytsky Lviv National Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Signs and Symptoms, Digestive
- Neoplasms by Histologic Type
- Neurobehavioral Manifestations
- Genital Diseases, Female
- Hemorrhage
- Genital Neoplasms, Female
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Muscle Tissue
- Perceptual Disorders
- Vomiting
- Nausea
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Uterine Hemorrhage
- Chronic Pain
- Acute Pain
- Postoperative Nausea and Vomiting
- Uterine Neoplasms
- Uterine Diseases
- Agnosia
- Leiomyoma
- Anesthesia and Analgesia
- Anesthesia
- Anesthesia, General
Other Study ID Numbers
- 7-A/2812
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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