Pain, PostoperativeNCT04277611
Comaprison Between QLB and ESPB in Patients for PCNL Operation
A study testing Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block. in people with Pain, Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
comparing the subcostal oblique Quadratus Lumborum block and the Erector Spinae plane block in patients undergoing percutaneous nephrolithotomy operation to get the best and longest postoperative analgesic effect. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2021to 30 Jun 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both sex
- Age: 18-60
- ASA (American Society of Anesthesiologists) class I and II
- Elective surgery
- Patients undergoing PNL surgery
Who cannot join
- Patient's refusal
- Allergy or contraindications to drugs used in the study
- Emergency surgery
- Psychiatric disorders
- Severely co-morbid patients
- Inflammation or infection over injection site
Show all 15Show fewer
- Bleeding diathesis; INR more than 1.5 and Platelet count less than 100,000/mm3
- Peripheral neuropathy
- Obese patients BMI ≥35
- Patients on previous opioid therapy
- Pre-operative haemoglobin <10 mg/dl
- Inability to properly describe postoperative pain to investigators
- Coagulation abnormalities
- History of drug addiction or alcohol abuse
- History of Previous renal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Ultrasound Guided Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy
comparing the subcostal oblique Quadratus Lumborum block and the Erector Spinae plane block in patients undergoing percutaneous nephrolithotomy operation to get the best and longest postoperative analgesic effect.
Read the detailed description
Here the investigators are going to compare between the Anterior approach for the subcostal oblique Quadratus Lumborum block (QLB) and the Erector Spinae Plane Block (ESPB) to determine their level of spread and their value in controlling postoperative pain in patients scheduled for Percutaneous Nephrolithotomy surgery. We hypothesized that quadratus lumborum is not inferior regarding the duration of analgesia when compared to erector spinae in patients undergoing percutaneous nephrolithotomy under general anesthesia.
- Conditions
- Pain, Postoperative
- Being tested
- Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.
- Keywords
- pain management, Nephrolithotomy, QLB, ESPB, Erector Spinae, Quadratus Lumborum, Anesthesia, ultrasound, regional anethesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.Procedure or surgery
patients undergo general anesthesia,will be put in prone position.In case of Quadratus Lumborum block 1-3 mL of normal saline is injected to produce hydro-dissection and spread cranially between the QL and kidney. The corresponding ultrasonographic sign is a lunar-shaped hypo-echoic fluid collection observed between the long axis of the kidney and QL muscle. 20 ml Bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is administered. In case of the ESPB The location of the needle tip is confirmed by hydro-dissection and after visualizing the fluid spread lifting the Erector Spinae off the transverse process, 20 ml bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is injected.
| Study group | Role | What they receive |
|---|---|---|
| QLB | Active comparator | The patient is in the prone position, an ultrasound probe is placed in a transverse, oblique, and paramedian orientation approximately lateral to the posterior axillary line. The needle is then inserted in-plane from the medial side of the transducer and advanced laterally to enter the interfascial plane between the Quadratus Lumborum muscle and the kidney. We confirmed that the local anesthetic appeared to press down the kidney in the ultrasound image Receives: Procedure: Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block. |
| ESPB | Active comparator | Using aseptic technique, an ultrasound probe is placed at the T9 vertebral level. After identifying the ribs and sliding towards the midline in a longitudinal parasagittal orientation, the overlying Erector Spinae is identified by visualization of the transition between the rib and transverse apophysis a block needle is inserted in plane with ultrasound beam and is advanced in a cephalo-caudal direction until the tip contacted the transverse process. Receives: Procedure: Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia
Total opioid consumption during the first 48hours postoperatively.
Measured: 48 hours
Secondary outcomes (7)
Analgesia
first Analgesic request postoperatively.
Measured: 24 hours
episodes of nausea and vomiting
to investigate if there is or not.
Measured: within 24 hours postoperative
Pain Scores using Visual Analog Scale (VAS) Scores
VAS is a scale to determine the patient's pain level.
Measured: 24 hours postoperative.
ambulation time
time from the end of the surgery to the first time to out-of-bed activity
Measured: 5 days postoperative
time of recovery of bowl movement
time from the end of the surgery to the first time of bowl movement
Measured: 5 days postoperative
patient satisfaction with anesthesia
Patient satisfaction with anesthesia was assessed using a 5-point scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied)
Measured: 48 hours postoperative.
postoperative length of hospital stay
till time of discharge
Measured: within 2 weeks postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start20 Apr 2021
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Bassem Halim Gadelsyed, Assiut University
- Investigators
- Amr Thabet, Lecturer, Study director, Assiut UniversityAlaa Attia, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277611
- Sponsor's protocol ID
- QLB and ESPB comparison
- Status last verified
- Sep 2022
- First submitted
- 18 Feb 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT04277611
- Acronym / sponsor ID
- QLB and ESPB comparison
- Conditions
- Pain, Postoperative
- Keywords
- pain management, Nephrolithotomy, QLB, ESPB, Erector Spinae, Quadratus Lumborum, Anesthesia, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 Feb 2020 (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.
comparing the subcostal oblique Quadratus Lumborum block and the Erector Spinae plane block in patients undergoing percutaneous nephrolithotomy operation to get the best and longest postoperative analgesic effect.
Detailed description
Here the investigators are going to compare between the Anterior approach for the subcostal oblique Quadratus Lumborum block (QLB) and the Erector Spinae Plane Block (ESPB) to determine their level of spread and their value in controlling postoperative pain in patients scheduled for Percutaneous Nephrolithotomy surgery. We hypothesized that quadratus lumborum is not inferior regarding the duration of analgesia when compared to erector spinae in patients undergoing percutaneous nephrolithotomy under general anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLB | Active comparator | Procedure: Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.The patient is in the prone position, an ultrasound probe is placed in a transverse, oblique, and paramedian orientation approximately lateral to the posterior axillary line. The needle is then inserted in-plane from the medial side of the transducer and advanced laterally to enter the interfascial plane between the Quadratus Lumborum muscle and the kidney. We confirmed that the local anesthetic appeared to press down the kidney in the ultrasound image |
| ESPB | Active comparator | Procedure: Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.Using aseptic technique, an ultrasound probe is placed at the T9 vertebral level. After identifying the ribs and sliding towards the midline in a longitudinal parasagittal orientation, the overlying Erector Spinae is identified by visualization of the transition between the rib and transverse apophysis a block needle is inserted in plane with ultrasound beam and is advanced in a cephalo-caudal direction until the tip contacted the transverse process. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both sex
- Age: 18-60
- ASA (American Society of Anesthesiologists) class I and II
- Elective surgery
- Patients undergoing PNL surgery
Key exclusion criteria (15 listed)
- Patient's refusal
- Allergy or contraindications to drugs used in the study
- Emergency surgery
- Psychiatric disorders
- Severely co-morbid patients
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 |
|---|---|---|
| Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.patients undergo general anesthesia,will be put in prone position.In case of Quadratus Lumborum block 1-3 mL of normal saline is injected to produce hydro-dissection and spread cranially between the QL and kidney. The corresponding ultrasonographic sign is a lunar-shaped hypo-echoic fluid collection observed between the long axis of the kidney and QL muscle. 20 ml Bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is administered. In case of the ESPB The location of the needle tip is confirmed by hydro-dissection and after visualizing the fluid spread lifting the Erector Spinae off the transverse process, 20 ml bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is injected. | Procedure or surgery | ESPB, QLB |
Primary outcome
Analgesia
Time frame: 48 hours
Total opioid consumption during the first 48hours postoperatively.
7 secondary outcomes
Analgesia
Time frame: 24 hours
episodes of nausea and vomiting
Time frame: within 24 hours postoperative
Pain Scores using Visual Analog Scale (VAS) Scores
Time frame: 24 hours postoperative.
ambulation time
Time frame: 5 days postoperative
time of recovery of bowl movement
Time frame: 5 days postoperative
patient satisfaction with anesthesia
Time frame: 48 hours postoperative.
postoperative length of hospital stay
Time frame: within 2 weeks postoperative.
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 7 Sep 2022.
- 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.
Amr Thabet, Lecturer study director
Assiut University
Alaa Attia, Professor study chair
Assiut 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 Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block. in people with Pain, Postoperative, run by Assiut University 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 5 inclusion and 15 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 7 Sep 2022. 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?
Analgesia (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2022; AzTrials last refreshed its copy on 26 Oct 2026.