Quadratus Lumborum BlockNCT04852874
Quadratus Lumborum Block as an Anesthetic Method for Percutaneous Nephrolithotomy
A study testing Ultrasound-guided Quadratus Lumborum Block in people with Quadratus Lumborum Block and Percutaneous Nephrolithotomy, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The study aims to investigate the efficacy and safety of QLB, as an anaesthetic method, for patients undergoing PCNL. Adult patients who agree to participate in the study will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quadratus Lumborum Block, Percutaneous Nephrolithotomy, Local Anesthesia
- What is being tested?
- Ultrasound-guided Quadratus Lumborum Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2021to 1 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who will undergo an elective unilateral PCNL and agree to participate in the study will be included
Who cannot join
- Uncooperable patients
- Pregnant women
- Untreated urinary tract infection
- Uncorrected coagulation disorder
- Known allergy to study medications
- Local infection at the site of injection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology Department, Al-Azhar University Hospital
Cairo
Ahmed Fahim, MD, 002025107333, urologyhospital@gmail.com
Ahmed El-Garhi, MD
About this study
Official title: Is Quadratus Lumborum Block an Efficient and Safe Anesthetic Method for Percutaneous Nephrolithotomy? A Feasibility Study
The study aims to investigate the efficacy and safety of QLB, as an anaesthetic method, for patients undergoing PCNL. Adult patients who agree to participate in the study will be included. Uncooperable patients, pregnant woman, active urinary tract infection, uncorrectable coagulation disorder, and those with known allergy to study medication will be excluded. Low dose spinal anaesthesia and Ultrasound-guided QLB will be performed. The success of the procedure, procedure-related complications, Intra- and post-operative hemodynamics, pain score, overall surgeon and patient satisfaction will be evaluated and reported.
Read the detailed description
Percutaneous nephrolithotomy (PCNL) is used more frequently than open surgery in the treatment of kidney stones as it is performed through a smaller surgical incision. Postoperative complex pain resulting from the renal capsule dilation and nephrostomy-tube-related stress is reported to prolong the recovery time, reduce patient comfort, and increase complication rates. Opioids, which are used for controlling Intra and postoperative pain, have significant side effects. Multi-modal analgesia regimen and regional anaesthesia methods have been reported to decrease the side effects, in addition to providing effective postoperative pain control.
The use of an intraoperative local anaesthetic or peripheral blocks as an analgesic has been reported for pain control in PCNL but only as analgesia not anaesthesia except loco-regional like spinal and epidural anaesthesia with limitation of time or cardiopulmonary side effects that usually in favour of general anaesthesia that is usually considered the most convenient and prudent way for providing anaesthesia for this operation in spite of its drawbacks.
The quadratus lumborum muscle block (QLB) was first described by Blanco in 2007 as a local anaesthetic injection into the anterolateral junction of the quadratus lumborum muscle (QLB type 1). QLB does not only stop somatic pain but also it inhibits visceral pain due to the spread of the local anaesthetic to the paravertebral space.
Some modifications of this technique were subsequently introduced: injection into the posterior segment of the quadratus lumborum muscle (QLB type2), injection between the quadratus lumborum muscle and the fascia of the psoas muscle using the trans muscular approach (QLB type 3), and injection into the quadratus lumborum muscle (QLB type 4) itself. It is evident that this block is effective in providing analgesia from T7 to L1 dermatomes, it is not only providing analgesia from the anterior abdominal wall but also it can reduce visceral pain.
Although the efficacy of QLB in abdominal surgery has been demonstrated in the literature, its use as an anaesthesia technique not ever reported.
In this study, the investigators introduce a new protocol in providing anaesthesia mainly by fascial peripheral block. It is considered new as it is the first time to our knowledge to use a fascial block as a main component of anaesthesia for PCNL and the investigators think that it may be used as a solo anaesthesia. This will lead to decreasing patient stay in the hospital, decreasing time for patient ambulation and regaining vitality and hemostasis that will all be in line with early rehabilitation after surgery (ERAS) protocol that is the aim of all health care services in modern medicine. Also, it will be the base for further research in more risky patient groups that may decrease the detrimental effect of general anaesthesia in these patient group which already have associated comorbidities and for more operation especially if unilateral.
In this study, the investigators will evaluate the efficacy and safety of ultrasound-guided QLB as an anaesthetic method in patients undergoing PCNL.
Adult patients who will undergo elective unilateral PCNL will be included. Low dose spinal anaesthesia will be done at L3-4 lumbar vertebrae. Then, ultrasound-guided QLB (QL 1,2,3) will be performed on the ipsilateral surgical side, using a low-frequency convex transducer. The total volume of injectate will not exceed 0.4 ml /kg of (bupivacaine 0.5%).
The success of the procedure, procedure-related complications, Intra- and post-operative hemodynamics, pain score, overall surgeon and patient satisfaction will be evaluated.
- Being tested
- Ultrasound-guided Quadratus Lumborum Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Quadratus Lumborum BlockProcedure or surgery
Low dose spinal anesthesia will be done at L3-4 lumbar vertebrae with bupivacaine 2.5 mg (0.5 ml Marcaine 0.5%) and fentanyl 25 µgm (0.5 ml) of fentanyl amp (100 µgm/ 2ml) to be added to 1.5 - 2 ml of free water to form total volume of 2.5- 3ml according to the patient height aiming level of T6 sensory level.
Quadratus lumorum block:
After 4 to 5 minutes, ultrasound guided quadratus lumborum block (QL 1,2,3) will be done unilaterally, using low-frequency convex probe, taking into consideration the total volume of injectate not exceeding 0.4 ml /kg of (bupivacaine 0.5%) to avoid local anesthesia systemic toxicity. This is equal to 0.8 ml/kg of (bupivacaine 0.25%).
After confirming the correct position of the needle, 0.2-3 ml/kg of 0.25% bupivacaine plus 1.5 mg dexamethasone and magnesium sulphate of 100 mg will be injected in each site of the QL 1,2,3 using the lean body weight. The lean body weight will be calculated by omni lean body mass online calculator.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided Quadratus Lumborum Block | Experimental | Not described Receives: Procedure: Ultrasound-guided Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the QLB
Accomplishing of the PCNL procedure with no need of alteration to general anesthesia with neutral or more better levels of surgeon and patient satisfaction using a five-point scale of customer Satisfaction survey score of 5 points
Measured: At the end of PCNL procedure.
Secondary outcomes (11)
Blood pressure
Measured: Intra-operative
Pulse
Measured: Intra-operative
spo2
Measured: Intra-operative
Visual analogue scale
0-to-10 scale, where 0 (no pain) and 10 (worst imaginable pain).
Measured: Intra-operative, and post-operative at 0,1,2, 4, 8, 12,16,20,24 hours
Time for the 1st analgesic requirement.
The time from performance the block until the patient asked analgesia with visual analogue visual analogue pain scale ≥ 4
Measured: Intra- and post-operative up to 24 hours
QLB-related complications
e.g of hypotension related to block, defined as decreases in mean arterial blood pressure more than 20% of the basal BP
Measured: Intra- and post-operative up to 24 hours
Patient's satisfaction
A five-point scale will be used to asses satisfaction, where 1 is unsatisfied and 5 fully satisfied.
Measured: Intra- and post-operative, up to 24 hours
Surgeon's satisfaction
A five-point scale will be used to asses satisfaction, where 1 is unsatisfied and 5 fully satisfied.
Measured: Intra- and post-operative up to 24 hours
PCNL complications
Measured: up to 3 months
Need for ancillary procedure
Measured: up to 3 months
Stone free rate
stone-free status is defined as no stones or residual fragment less than 4 mm on NCCT
Measured: up to 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start3 Apr 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadratus Lumborum BlockStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, open-label, interventional study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul-fotouh Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852874
- Sponsor's protocol ID
- Uro_Azhar_8_021
- Status last verified
- Feb 2023
- First submitted
- 9 Apr 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Quadratus Lumborum Block an Efficient and Safe Anesthetic Method for Percutaneous Nephrolithotomy? A Feasibility Study
- ClinicalTrials.gov ID
- NCT04852874
- Acronym / sponsor ID
- Uro_Azhar_8_021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 21 Apr 2021 (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 study aims to investigate the efficacy and safety of QLB, as an anaesthetic method, for patients undergoing PCNL. Adult patients who agree to participate in the study will be included. Uncooperable patients, pregnant woman, active urinary tract infection, uncorrectable coagulation disorder, and those with known allergy to study medication will be excluded. Low dose spinal anaesthesia and Ultrasound-guided QLB will be performed. The success of the procedure, procedure-related complications, Intra- and post-operative hemodynamics, pain score, overall surgeon and patient satisfaction will be evaluated and reported.
Detailed description
Percutaneous nephrolithotomy (PCNL) is used more frequently than open surgery in the treatment of kidney stones as it is performed through a smaller surgical incision. Postoperative complex pain resulting from the renal capsule dilation and nephrostomy-tube-related stress is reported to prolong the recovery time, reduce patient comfort, and increase complication rates. Opioids, which are used for controlling Intra and postoperative pain, have significant side effects. Multi-modal analgesia regimen and regional anaesthesia methods have been reported to decrease the side effects, in addition to providing effective postoperative pain control.
The use of an intraoperative local anaesthetic or peripheral blocks as an analgesic has been reported for pain control in PCNL but only as analgesia not anaesthesia except loco-regional like spinal and epidural anaesthesia with limitation of time or cardiopulmonary side effects that usually in favour of general anaesthesia that is usually considered the most convenient and prudent way for providing anaesthesia for this operation in spite of its drawbacks.
The quadratus lumborum muscle block (QLB) was first described by Blanco in 2007 as a local anaesthetic injection into the anterolateral junction of the quadratus lumborum muscle (QLB type 1). QLB does not only stop somatic pain but also it inhibits visceral pain due to the spread of the local anaesthetic to the paravertebral space.
Some modifications of this technique were subsequently introduced: injection into the posterior segment of the quadratus lumborum muscle (QLB type2), injection between the quadratus lumborum muscle and the fascia of the psoas muscle using the trans muscular approach (QLB type 3), and injection into the quadratus lumborum muscle (QLB type 4) itself. It is evident that this block is effective in providing analgesia from T7 to L1 dermatomes, it is not only providing analgesia from the anterior abdominal wall but also it can reduce visceral pain.
Although the efficacy of QLB in abdominal surgery has been demonstrated in the literature, its use as an anaesthesia technique not ever reported.
In this study, the investigators introduce a new protocol in providing anaesthesia mainly by fascial peripheral block. It is considered new as it is the first time to our knowledge to use a fascial block as a main component of anaesthesia for PCNL and the investigators think that it may be used as a solo anaesthesia. This will lead to decreasing patient stay in the hospital, decreasing time for patient ambulation and regaining vitality and hemostasis that will all be in line with early rehabilitation after surgery (ERAS) protocol that is the aim of all health care services in modern medicine. Also, it will be the base for further research in more risky patient groups that may decrease the detrimental effect of general anaesthesia in these patient group which already have associated comorbidities and for more operation especially if unilateral.
In this study, the investigators will evaluate the efficacy and safety of ultrasound-guided QLB as an anaesthetic method in patients undergoing PCNL.
Adult patients who will undergo elective unilateral PCNL will be included. Low dose spinal anaesthesia will be done at L3-4 lumbar vertebrae. Then, ultrasound-guided QLB (QL 1,2,3) will be performed on the ipsilateral surgical side, using a low-frequency convex transducer. The total volume of injectate will not exceed 0.4 ml /kg of (bupivacaine 0.5%).
The success of the procedure, procedure-related complications, Intra- and post-operative hemodynamics, pain score, overall surgeon and patient satisfaction will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, open-label, interventional study
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided Quadratus Lumborum Block | Experimental | Procedure: Ultrasound-guided Quadratus Lumborum Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who will undergo an elective unilateral PCNL and agree to participate in the study will be included
Key exclusion criteria (6 listed)
- Uncooperable patients
- Pregnant women
- Untreated urinary tract infection
- Uncorrected coagulation disorder
- Known allergy to study medications
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 |
|---|---|---|
| Ultrasound-guided Quadratus Lumborum BlockLow dose spinal anesthesia will be done at L3-4 lumbar vertebrae with bupivacaine 2.5 mg (0.5 ml Marcaine 0.5%) and fentanyl 25 µgm (0.5 ml) of fentanyl amp (100 µgm/ 2ml) to be added to 1.5 - 2 ml of free water to form total volume of 2.5- 3ml according to the patient height aiming level of T6 sensory level. Quadratus lumorum block: After 4 to 5 minutes, ultrasound guided quadratus lumborum block (QL 1,2,3) will be done unilaterally, using low-frequency convex probe, taking into consideration the total volume of injectate not exceeding 0.4 ml /kg of (bupivacaine 0.5%) to avoid local anesthesia systemic toxicity. This is equal to 0.8 ml/kg of (bupivacaine 0.25%). After confirming the correct position of the needle, 0.2-3 ml/kg of 0.25% bupivacaine plus 1.5 mg dexamethasone and magnesium sulphate of 100 mg will be injected in each site of the QL 1,2,3 using the lean body weight. The lean body weight will be calculated by omni lean body mass online calculator. | Procedure or surgery | Ultrasound-guided Quadratus Lumborum Block |
Primary outcome
Success of the QLB
Time frame: At the end of PCNL procedure.
Accomplishing of the PCNL procedure with no need of alteration to general anesthesia with neutral or more better levels of surgeon and patient satisfaction using a five-point scale of customer Satisfaction survey score of 5 points
11 secondary outcomes
Blood pressure
Time frame: Intra-operative
Pulse
Time frame: Intra-operative
spo2
Time frame: Intra-operative
Visual analogue scale
Time frame: Intra-operative, and post-operative at 0,1,2, 4, 8, 12,16,20,24 hours
Time for the 1st analgesic requirement.
Time frame: Intra- and post-operative up to 24 hours
QLB-related complications
Time frame: Intra- and post-operative up to 24 hours
Patient's satisfaction
Time frame: Intra- and post-operative, up to 24 hours
Surgeon's satisfaction
Time frame: Intra- and post-operative up to 24 hours
PCNL complications
Time frame: up to 3 months
Need for ancillary procedure
Time frame: up to 3 months
Stone free rate
Time frame: up to 3 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Quadratus Lumborum Block in people with Quadratus Lumborum Block and Percutaneous Nephrolithotomy, run by Al-Azhar 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abul-fotouh Ahmed, MD (00201001066756, abulfotouhahmed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the QLB (time frame: At the end of PCNL procedure.). 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 14 Feb 2023.