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

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

Study Overview

• Status: Completed
• Conditions: Lower Abdominal Surgery
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Device: Ultrasound device; Drug: Dexamethasone; Device: echogenic needle

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Fayoum Governorate
    • Al Fayyūm, Fayoum Governorate, Egypt, 63514
      • Fayoum University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (QL) group; In (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone	Drug: Bupivacaine Hydrochloride; 20mg of Bupivacaine hydrochloride as local anesthetic will be used in (QL) group and (ESB) group; Other Names: Marcaine 0.25%; Device: Ultrasound device; 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 .; Drug: Dexamethasone; injection of 4mg dexamethasone in each block; Other Names: Dexamethasone 4mg/ml; Device: echogenic needle; 22- gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) for performing the blocks .
Active Comparator: (ESB) group; In (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone	Drug: Bupivacaine Hydrochloride; 20mg of Bupivacaine hydrochloride as local anesthetic will be used in (QL) group and (ESB) group; Other Names: Marcaine 0.25%; Device: Ultrasound device; 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 .; Drug: Dexamethasone; injection of 4mg dexamethasone in each block; Other Names: Dexamethasone 4mg/ml; Device: echogenic needle; 22- gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) for performing the blocks .

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of first using of analgesic	The time of first use of morphine in hours	24 hours
Visual Analogue Score immediately .	measuring post operative pain level using Visual Analogue Score (VAS) range from (0) no pain to (10) sever pain immediately post operatively	1 minute post operative
Visual Analogue Score at (4)	measuring post operative pain level using Visual Analogue Score (VAS)at(4)hours post operatively	4 hour post operative
Visual Analogue Score at (8)	measuring post operative pain level using Visual Analogue Score (VAS)at(8)hours post operatively	8 hours post operative
Visual Analogue Score at (12)	measuring post operative pain level using Visual Analogue Score at(VAS)(12)hours post operatively	12 hours post operative
Visual Analogue Score at ( 24)	measuring post operative pain level using Visual Analogue Score (VAS)at(24)hours post operatively	24 hours post operative
Age	in years	1 hour before operation
Weight	in kg	1 hour before operation
height	meter	1 hour before operation
BMI	kg/m2	1 hour before operation

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Principal Investigator: rana A. Abdelghaffar, MD, faculty of medicine ,Fayum university

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Quadratus Lumborum; Erecto Spinae plane
• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Enzyme Inhibitors; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Dexamethasone; Dexamethasone acetate; BB 1101; Bupivacaine
• Other Study ID Numbers: D237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No