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

NCT ID: NCT05524038

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2025-02-01

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.

Conditions

Lower Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

(QL) group

In (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: DRUG

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

Ultrasound device

Intervention Type: 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 .

Dexamethasone

Intervention Type: DRUG

injection of 4mg dexamethasone in each block

echogenic needle

Intervention Type: DEVICE

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

(ESB) group

In (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: DRUG

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

Ultrasound device

Intervention Type: 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 .

Dexamethasone

Intervention Type: DRUG

injection of 4mg dexamethasone in each block

echogenic needle

Intervention Type: DEVICE

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

Interventions

Bupivacaine Hydrochloride

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

Intervention Type: DRUG

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 .

Intervention Type: DEVICE

Dexamethasone

injection of 4mg dexamethasone in each block

Intervention Type: DRUG

echogenic needle

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

Intervention Type: DEVICE

Other Intervention Names

Marcaine 0.25%; Dexamethasone 4mg/ml

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rana Ahmed Abdelghaffar

lecturer of anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rana A. Abdelghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine ,Fayum university

Locations

Fayoum University hospital

Al Fayyum, Fayoum Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 27501016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28188611 (View on PubMed)

Other Identifiers

D237

Identifier Type: -

Identifier Source: org_study_id