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

Lower Abdominal Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524038
• Other study ID #: D237
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: October 2022
• Source: Fayoum University Hospital
• Contact: mohamed M. abd elhamid elbarbary, master
• Phone: o1o98756760
• Email: mohamedelbarbary68[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: February 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Abdominal Surgery

Intervention

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

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

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

Locations

Country	Name	City	State
Egypt	Fayoum University hospital	Al Fayyum	Fayoum Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time of first using of analgesic	The time of first use of morphine in hours	24 hours
Other	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
Other	Visual Analogue Score at (4)	measuring post operative pain level using Visual Analogue Score (VAS)at(4)hours post operatively	4 hour post operative
Other	Visual Analogue Score at (8)	measuring post operative pain level using Visual Analogue Score (VAS)at(8)hours post operatively	8 hours post operative
Other	Visual Analogue Score at (12)	measuring post operative pain level using Visual Analogue Score at(VAS)(12)hours post operatively	12 hours post operative
Other	Visual Analogue Score at ( 24)	measuring post operative pain level using Visual Analogue Score (VAS)at(24)hours post operatively	24 hours post operative
Other	Age	in years	1 hour before operation
Other	Weight	in kg	1 hour before operation
Other	height	meter	1 hour before operation
Other	BMI	kg/m2	1 hour before operation
Primary	morphine consumption	Millie gram	24 hours after the end of operation
Secondary	Ease of performance.	time required to perform the block in minutes .	during performance of the block
Secondary	Bowel injury	yes or no	24hours after operation
Secondary	intra vascular injection	yes or no	24hours after operation
Secondary	Hematoma formation	yes or no	24hours after operation
Secondary	Pruritus	yes or no	24hours after operation
Secondary	Nausea	yes or no	24hours after operation
Secondary	vomiting	yes or no	24hours after operation
Secondary	patient satisfaction	According to a satisfaction score (poor = zero; fair = one; good = two; excellent= 3).	24 hours after operation