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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05524038
Enrollment
48
Registered
2022-09-01
Start date
2021-09-01
Completion date
2025-02-01
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Abdominal Surgery

Keywords

Quadratus Lumborum, Erecto Spinae plane

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.

Interventions

DRUGBupivacaine Hydrochloride

20mg of Bupivacaine hydrochloride as local anesthetic will be used in (QL) group and (ESB) group

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 .

DRUGDexamethasone

injection of 4mg dexamethasone in each block

22- gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) for performing the blocks .

Sponsors

Fayoum University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Randomization will be done by random sequence number generated by the computer kept in sealed envelopes. Those envelopes will be opened on the day of surgery when the patient is in the operating room and participant will receive either (QLB) or (ESPB) as per the envelope.

Intervention model description

1. (QL) QLB group 2. (ESB) group

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
morphine consumption24 hours after the end of operationMillie gram

Secondary

MeasureTime frameDescription
Bowel injury24hours after operationyes or no
intra vascular injection24hours after operationyes or no
Hematoma formation24hours after operationyes or no
Ease of performance.during performance of the blocktime required to perform the block in minutes .
Nausea24hours after operationyes or no
vomiting24hours after operationyes or no
patient satisfaction24 hours after operationAccording to a satisfaction score (poor = zero; fair = one; good = two; excellent= 3).
Pruritus24hours after operationyes or no

Other

MeasureTime frameDescription
time of first using of analgesic24 hoursThe time of first use of morphine in hours
BMI1 hour before operationkg/m2
Visual Analogue Score immediately .1 minute post operativemeasuring post operative pain level using Visual Analogue Score (VAS) range from (0) no pain to (10) sever pain immediately post operatively
Visual Analogue Score at (4)4 hour post operativemeasuring post operative pain level using Visual Analogue Score (VAS)at(4)hours post operatively
Visual Analogue Score at (8)8 hours post operativemeasuring post operative pain level using Visual Analogue Score (VAS)at(8)hours post operatively
Visual Analogue Score at (12)12 hours post operativemeasuring post operative pain level using Visual Analogue Score at(VAS)(12)hours post operatively
Visual Analogue Score at ( 24)24 hours post operativemeasuring post operative pain level using Visual Analogue Score (VAS)at(24)hours post operatively
Age1 hour before operationin years
Weight1 hour before operationin kg
height1 hour before operationmeter

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026