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Lower Abdominal SurgeryNCT05524038

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

A study testing Bupivacaine Hydrochloride, Ultrasound device and Dexamethasone in people with Lower Abdominal Surgery, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lower Abdominal Surgery
What is being tested?
Bupivacaine Hydrochloride, Ultrasound device and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteEgypt
Study dates
1 Sep 2021to 1 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients age 18-60 years old.
  • Patients scheduled for elective abdominal surgeries
  • ASA classification I, II.
  • Ability to sign the consent.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University hospital

    Al Fayyum, Fayoum Governorate, 63514

Other trials in Egypt

About this study

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

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

Read the 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.

Being tested
Bupivacaine Hydrochloride, Ultrasound device, Dexamethasone, echogenic needle
Keywords
Quadratus Lumborum, Erecto Spinae plane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine HydrochlorideDrug

    Also called Marcaine 0.25%

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

  • Ultrasound deviceDevice

    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 .

  • DexamethasoneDrug

    Also called Dexamethasone 4mg/ml

    injection of 4mg dexamethasone in each block

  • echogenic needleDevice

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

Study groups in NCT05524038
Study groupRoleWhat they receive
(QL) groupActive comparatorIn (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone
Receives: Drug: Bupivacaine Hydrochloride; Device: Ultrasound device; Drug: Dexamethasone; Device: echogenic needle
(ESB) groupActive comparatorIn (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone
Receives: Drug: Bupivacaine Hydrochloride; Device: Ultrasound device; Drug: Dexamethasone; Device: echogenic needle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. morphine consumption

    Millie gram

    Measured: 24 hours after the end of operation

Secondary outcomes (8)
  1. Ease of performance.

    time required to perform the block in minutes .

    Measured: during performance of the block

  2. Bowel injury

    yes or no

    Measured: 24hours after operation

  3. intra vascular injection

    yes or no

    Measured: 24hours after operation

  4. Hematoma formation

    yes or no

    Measured: 24hours after operation

  5. Pruritus

    yes or no

    Measured: 24hours after operation

  6. Nausea

    yes or no

    Measured: 24hours after operation

  7. vomiting

    yes or no

    Measured: 24hours after operation

  8. patient satisfaction

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

    Measured: 24 hours after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start1 Sep 2021
  3. Primary completion1 May 2024
  4. Study completion1 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1. (QL) QLB group 2. (ESB) group
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05524038
Sponsor's protocol ID
D237
Status last verified
Feb 2025
First submitted
29 Aug 2022
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 27501016
  • 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.

    PubMed 28188611

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine Hydrochloride, Ultrasound device and Dexamethasone in people with Lower Abdominal Surgery, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

morphine consumption (time frame: 24 hours after the end of operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05524038, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.

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