Comparison Between the Quadratus Lumborum Block ,Erector Spinae Plane Block in Lower Abdominal Surgery

Study Overview
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Brief Summary
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the purpose of study is comparison between the analgesic effect of two techniques in adult lower abdominal surgeries

Detailed Description
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the study will be performed from November 2021 to January 2023 at Fayoum University hospital after approval of the local institutional ethics committee and local institutional review board .A detailed informed consent will be signed by the eligible participants before recruitment and randomization. Preoperative preparations and Premedication :• Both groups will be assessed by history taking, careful examination ,and laboratory investigations like: Complete blood count (CBC), coagulation profile:(prothrombin concentration(PC),Partial thromboplastin time(PTT),International Normalized Ratio(INR) ) , kidney function, liver function, ECG for patient >40 years old or indicated cases, specific investigations to each disease .•the investigators will teach the patients Visual Analogue Score (VAS) and train them. Intra operative technique and management: When patients reach Theater, standard American Society of Anesthesiology(ASA) monitoring by (noninvasive blood pressure (NIBP), pulse oximetry, electrocardiography, and capnography) will be applied. the investigators will allocate basal data for each patient like: heart rate (HR), systolic and diastolic blood pressure, mean arterial blood pressure and arterial oxygen saturation will be recorded. Intravenous cannulation (IV) and intravenous fluid will be started. Intravenous Midazolam 0.03-0.05 mg/kg will be administered to all patients as premedication, Then the patients undergoing general anesthesia, At the first pre-oxygenation with O2100% for at least 3-5 min then the investigators will start Induction of anesthesia for both groups, general anesthesia will be induced with intravenous injection of fentanyl (1-2 µg/kg) and propofol (1, 5 - 2 mg/kg), and then atracurium (0.5 mg/kg) will be injected for endotracheal intubation. Mechanical ventilation will be maintained by controlled mechanical ventilation (CMV) mode with tidal volume ( 6-8ml /kg) with oxygen and air (50:50) with target of EtCo2≈ 30-40 mmHg, anesthesia will be maintained with isoflurane 1%-2% , Incremental dose of atracurium (0.1 mg/kg) will be given every 20 min or when needed. In addition, 0.5μg/kg fentanyl will be given intraoperatively once needed (increase of heart rate or NIBP more than 20% of the basal records) After endotracheal intubation and finishing the operation before awakening of patients the anesthesiologist will perform either the (QL) block technique or the (ESPB) block technique. Statistical analysis: The collected data will be organized, tabulated and statistically analyzed using SPSS software statistical computer package version 22 (SPSS Inc, USA). For quantitative data, the mean and standard deviation (SD) or median and interquartile range will be calculated. Independent-t test or Mann-Whitney U test, when appropriate, will be used as a test of significance. Qualitative data will be presented as number and percentages, chi square (χ2) will be used as a test of significance. For interpretation of results of tests of significance, significance will be adopted at P ≤ 0.05. Sample size was calculated using (G power version 3). Minimal sample size of patients was 20 in each group needed to get power level 0.90, alpha level 0.05 (two tailed) and effect size of 1.08 for the overall dose of morphine. To overcome problem of loss of follow up, calculated sample size was increased by 20% to reach 24 in each group.

Official Title
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Comparison Between the Analgesic Effects of Ultrasound-guided Unilateral Quadratus Lumborum Block (Lateral Approach) Versus Erector Spinae Plane Block in Patients Undergoing Unilateral Lower Abdominal Surgery

Conditions
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Lower Abdominal Surgery

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride
* Device: Ultrasound device
* Drug: Dexamethasone
* Device: echogenic needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18-60 years old. Patients scheduled for elective abdominal surgeries ASA classification I, II. Ability to sign the consent. Exclusion Criteria: Patient refusal. Coagulation disorders. Skin lesions or infection at site of proposed needle. Known allergy to local anesthetics, or opioids. Patients suffering from neurological or mental disease. Opioid consumption 48 hours before the operation. Sever Obesity body mass index(BMI) >35 Difficulty in Ultrasonographic identification.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: (QL) QLB group (ESB) group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (QL) group<br>In (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone | Drug: Bupivacaine Hydrochloride<br>* 20mg of Bupivacaine hydrochloride as local anesthetic will be used in (QL) group and (ESB) group<br>* Other names: Marcaine 0.25%;Device: Ultrasound device<br>* high-frequency linear probe covered with sterile sheath Active Array L12-4 (8-13MHz) of an ultrasound machine (Philips clear vue350, Philips Healthcare, Andover MA01810, USA) for performing the blocks .<br>Drug: Dexamethasone<br>* injection of 4mg dexamethasone in each block<br>* Other names: Dexamethasone 4mg/ml;Device: echogenic needle<br>* 22- gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) for performing the blocks .<br>|
| Active Comparator: (ESB) group<br>In (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone | Drug: Bupivacaine Hydrochloride<br>* 20mg of Bupivacaine hydrochloride as local anesthetic will be used in (QL) group and (ESB) group<br>* Other names: Marcaine 0.25%;Device: Ultrasound device<br>* high-frequency linear probe covered with sterile sheath Active Array L12-4 (8-13MHz) of an ultrasound machine (Philips clear vue350, Philips Healthcare, Andover MA01810, USA) for performing the blocks .<br>Drug: Dexamethasone<br>* injection of 4mg dexamethasone in each block<br>* Other names: Dexamethasone 4mg/ml;Device: echogenic needle<br>* 22- gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) for performing the blocks .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption | Millie gram | 24 hours after the end of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of performance. | time required to perform the block in minutes . | during performance of the block | 
| Bowel injury | yes or no | 24hours after operation | 
| intra vascular injection | yes or no | 24hours after operation | 
| Hematoma formation | yes or no | 24hours after operation | 
| Pruritus | yes or no | 24hours after operation | 
| Nausea | yes or no | 24hours after operation | 
| vomiting | yes or no | 24hours after operation | 
| patient satisfaction | According to a satisfaction score (poor = zero; fair = one; good = two; excellent= 3). | 24 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quadratus Lumborum, Erecto Spinae plane