Skip to main content
OpenTrials
Completed

NCT Number: NCT05524038

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University hospital

Al Fayyum, Fayoum Governorate, 63514, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine Hydrochloride

Drug

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

Other names: Marcaine 0.25%

Ultrasound device

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

Drug

injection of 4mg dexamethasone in each block

Other names: Dexamethasone 4mg/ml

echogenic needle

Device

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

Primary outcomes

  1. morphine consumption

    Time frame: 24 hours after the end of operation

    Millie gram

Secondary outcomes

  1. Ease of performance.

    Time frame: during performance of the block

    time required to perform the block in minutes .

  2. Bowel injury

    Time frame: 24hours after operation

    yes or no

  3. intra vascular injection

    Time frame: 24hours after operation

    yes or no

  4. Hematoma formation

    Time frame: 24hours after operation

    yes or no

  5. Pruritus

    Time frame: 24hours after operation

    yes or no

  6. Nausea

    Time frame: 24hours after operation

    yes or no

  7. vomiting

    Time frame: 24hours after operation

    yes or no

  8. patient satisfaction

    Time frame: 24 hours after operation

    According to a satisfaction score (poor = zero; fair = one; good = two; excellent= 3).

Other outcomes

  1. time of first using of analgesic

    Time frame: 24 hours

    The time of first use of morphine in hours

  2. Visual Analogue Score immediately .

    Time frame: 1 minute post operative

    measuring post operative pain level using Visual Analogue Score (VAS) range from (0) no pain to (10) sever pain immediately post operatively

  3. Visual Analogue Score at (4)

    Time frame: 4 hour post operative

    measuring post operative pain level using Visual Analogue Score (VAS)at(4)hours post operatively

  4. Visual Analogue Score at (8)

    Time frame: 8 hours post operative

    measuring post operative pain level using Visual Analogue Score (VAS)at(8)hours post operatively

  5. Visual Analogue Score at (12)

    Time frame: 12 hours post operative

    measuring post operative pain level using Visual Analogue Score at(VAS)(12)hours post operatively

  6. Visual Analogue Score at ( 24)

    Time frame: 24 hours post operative

    measuring post operative pain level using Visual Analogue Score (VAS)at(24)hours post operatively

  7. Age

    Time frame: 1 hour before operation

    in years

  8. Weight

    Time frame: 1 hour before operation

    in kg

  9. height

    Time frame: 1 hour before operation

    meter

  10. BMI

    Time frame: 1 hour before operation

    kg/m2

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 1, 2022
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.