Clinical trial NCT05524038: Comparison Between the Quadratus Lumborum Block ,Erector Spinae Plane Block in Lower Abdominal Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Abdominal Surgery
Keywords: Quadratus Lumborum
Erecto Spinae plane
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. (QL) QLB group
2. (ESB) group
Primary purpose: TREATMENT

Brief summary: the purpose of study is comparison between the analgesic effect of two techniques in adult lower abdominal surgeries

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: morphine consumption
timeFrame: 24 hours after the end of operation
Secondary outcomes:
measure: Ease of performance.
timeFrame: during performance of the block
measure: Bowel injury
timeFrame: 24hours after operation
measure: intra vascular injection
timeFrame: 24hours after operation
measure: Hematoma formation
timeFrame: 24hours after operation
measure: Pruritus
timeFrame: 24hours after operation
measure: Nausea
timeFrame: 24hours after operation
measure: vomiting
timeFrame: 24hours after operation
measure: patient satisfaction
timeFrame: 24 hours after operation
Other outcomes:
measure: time of first using of analgesic
timeFrame: 24 hours
measure: Visual Analogue Score immediately .
timeFrame: 1 minute post operative
measure: Visual Analogue Score at (4)
timeFrame: 4 hour post operative
measure: Visual Analogue Score at (8)
timeFrame: 8 hours post operative
measure: Visual Analogue Score at (12)
timeFrame: 12 hours post operative
measure: Visual Analogue Score at ( 24)
timeFrame: 24 hours post operative
measure: Age
timeFrame: 1 hour before operation
measure: Weight
timeFrame: 1 hour before operation
measure: height
timeFrame: 1 hour before operation
measure: BMI
timeFrame: 1 hour before operation
Locations:
city: Al Fayyūm
country: Egypt
facility: Fayoum University hospital
state: Fayoum Governorate
Study officials:
affiliation: faculty of medicine ,Fayum university
name: rana A. Abdelghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
citation: El-Boghdadly K, Pawa A. The erector spinae plane block: plane and simple. Anaesthesia. 2017 Apr;72(4):434-438. doi: 10.1111/anae.13830. Epub 2017 Feb 11. No abstract available.