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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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.
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.
- Conditions
- Lower Abdominal Surgery
- 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 group | Role | What they receive |
|---|---|---|
| (QL) group | Active comparator | In (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) group | Active comparator | In (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.
morphine consumption
Millie gram
Measured: 24 hours after the end of operation
Secondary outcomes (8)
Ease of performance.
time required to perform the block in minutes .
Measured: during performance of the block
Bowel injury
yes or no
Measured: 24hours after operation
intra vascular injection
yes or no
Measured: 24hours after operation
Hematoma formation
yes or no
Measured: 24hours after operation
Pruritus
yes or no
Measured: 24hours after operation
Nausea
yes or no
Measured: 24hours after operation
vomiting
yes or no
Measured: 24hours after operation
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.
- First posted1 Sep 2022
- Study start1 Sep 2021
- Primary completion1 May 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Ahmed Abdelghaffar, Fayoum University Hospital
- Investigators
- rana A. Abdelghaffar, MD, Principal investigator, faculty of medicine ,Fayum university
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 27501016El-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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05524038
- Acronym / sponsor ID
- D237
- Conditions
- Lower Abdominal Surgery
- Keywords
- Quadratus Lumborum, Erecto Spinae plane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 1. (QL) QLB group 2. (ESB) group
| Arm | Type | Receives |
|---|---|---|
| (QL) group | Active comparator | Drug: Bupivacaine Hydrochloride, Device: Ultrasound device, Drug: Dexamethasone, Device: echogenic needleIn (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone |
| (ESB) group | Active comparator | Drug: Bupivacaine Hydrochloride, Device: Ultrasound device, Drug: Dexamethasone, Device: echogenic needleIn (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age 18-60 years old.
- Patients scheduled for elective abdominal surgeries
- ASA classification I, II.
- Ability to sign the consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine HydrochlorideAlso: Marcaine 0.25%20mg of Bupivacaine hydrochloride as local anesthetic will be used in (QL) group and (ESB) group | Drug | (ESB) group, (QL) group |
| Ultrasound devicehigh-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 . | Device | (ESB) group, (QL) group |
| DexamethasoneAlso: Dexamethasone 4mg/mlinjection of 4mg dexamethasone in each block | Drug | (ESB) group, (QL) group |
| echogenic needle22- gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) for performing the blocks . | Device | (ESB) group, (QL) group |
Primary outcome
morphine consumption
Time frame: 24 hours after the end of operation
Millie gram
8 secondary outcomes
Ease of performance.
Time frame: during performance of the block
Bowel injury
Time frame: 24hours after operation
intra vascular injection
Time frame: 24hours after operation
Hematoma formation
Time frame: 24hours after operation
Pruritus
Time frame: 24hours after operation
Nausea
Time frame: 24hours after operation
vomiting
Time frame: 24hours after operation
patient satisfaction
Time frame: 24 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Background: PubMed 27501016Forero 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.
- Background: PubMed 28188611El-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rana A. Abdelghaffar, MD principal investigator
faculty of medicine ,Fayum university
1 site in 1 country: see every site and its status.
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.