Postoperative Pain, AcutePhase 4NCT05386121
Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children
A Phase 4 study testing Ultrasound-guided Erector Spinae Plane Block, Ultrasound-guided Quadratus Lumborum Block and Ultrasound Machine in people with Postoperative Pain, Acute, run by Cairo University.
Trial summary
Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery \& early discharge of patients. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Ultrasound-guided Erector Spinae Plane Block, Ultrasound-guided Quadratus Lumborum Block and Ultrasound Machine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2022to 15 Sep 2022
- Phase
- Phase 4
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American society of anesthesiologists (ASA) class I and II
- Children undergoing unilateral open renal surgeries
Who cannot join
- Parents refusal for the block
- Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
- Skin lesion, wounds or infection at the puncture site.
- Known allergy to local anesthetic drugs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery \& early discharge of patients. Side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use.
Pediatric regional anesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. Neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time \& hospital stay. Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. However, its major side effect is urinary retention and excessive motor block.
Read more
Considerable progress has been made in the practice of PRA over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks.
In this study, the investigators will compare the ultrasound guided quadratus lumborum block (QLB) with erector spinae plane block (ESPB), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. The study hypothesis is that QLB can provide a more superior postoperative pain relief to ESPB in children undergoing open renal surgeries.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Ultrasound-guided Erector Spinae Plane Block, Ultrasound-guided Quadratus Lumborum Block, Ultrasound Machine, Echogenic needle, Fentanyl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Erector Spinae Plane BlockProcedure or surgery
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane deep to erector spinae muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline and observing the fluid lifting the erector spinae muscle off the transverse process (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the spinous process on a parasagittal plane, to visualize the erector spinae muscle and transverse process, directing the needle craniocaudally using the in-plane technique. The spread of the injectate will be observed to distribute within this plane.
Ultrasound-guided Quadratus Lumborum BlockProcedure or surgery
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane between the quadratus lumborum and psoas major muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the L2 spinous process on an axial plane, to visualize the transverse process with psoas major muscle anterior, quadratus lumborum muscle lateral and erector spinae muscle posterior to it. The needle is inserted from the medial side of the probe and advanced laterally using the in-plane technique. The spread of the injectate will be observed to distribute within the target plane.
Ultrasound MachineDevice
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
Echogenic needleDevice
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
FentanylDrug
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
PethidineDrug
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6. Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block (ESPB) group | Active comparator | 30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125% Receives: Procedure: Ultrasound-guided Erector Spinae Plane Block; Device: Ultrasound Machine; Device: Echogenic needle; Drug: Fentanyl; Drug: Pethidine |
| Quadratus lumborum block (QLB) group | Active comparator | 30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125% Receives: Procedure: Ultrasound-guided Quadratus Lumborum Block; Device: Ultrasound Machine; Device: Echogenic needle; Drug: Fentanyl; Drug: Pethidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first postoperative rescue analgesia
Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
Measured: 12 hours
Secondary outcomes (5)
Total opioid analgesic consumption in the first 12 hours postoperative period
when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score ˃ 6 in the first 12 hours postoperatively. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
Measured: from time of patient transfer to the PACU, till 12 hours postoperatively
Intraoperative mean arterial blood pressure
measured from induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
Measured: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Intraoperative heart rate
measured before and after induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
Measured: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Postoperative pain score
measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery
Measured: from time of patient transfer to the PACU, till 12 hours postoperatively
Block performance time
Time to perform ultrasound guided nerve block
Measured: Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start20 May 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Mohammed Assem Nawwar, Cairo University
- Investigators
- Nevine M Gouda, Study chair, Cairo UniversitySherif M Soaida, Study chair, Cairo UniversityIsmail S Hammad, Study chair, Cairo UniversityAhmed T Bahnaswy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386121
- Sponsor's protocol ID
- md-13-2022
- Status last verified
- May 2022
- First submitted
- 8 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT05386121
- Acronym / sponsor ID
- md-13-2022
- Conditions
- Postoperative Pain, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 23 May 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.
Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery \& early discharge of patients. Side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use.
Pediatric regional anesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. Neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time \& hospital stay. Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. However, its major side effect is urinary retention and excessive motor block.
Considerable progress has been made in the practice of PRA over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks.
In this study, the investigators will compare the ultrasound guided quadratus lumborum block (QLB) with erector spinae plane block (ESPB), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. The study hypothesis is that QLB can provide a more superior postoperative pain relief to ESPB in children undergoing open renal surgeries.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block (ESPB) group | Active comparator | Procedure: Ultrasound-guided Erector Spinae Plane Block, Device: Ultrasound Machine, Device: Echogenic needle, Drug: Fentanyl, Drug: Pethidine30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125% |
| Quadratus lumborum block (QLB) group | Active comparator | Procedure: Ultrasound-guided Quadratus Lumborum Block, Device: Ultrasound Machine, Device: Echogenic needle, Drug: Fentanyl, Drug: Pethidine30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125% |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American society of anesthesiologists (ASA) class I and II
- Children undergoing unilateral open renal surgeries
Key exclusion criteria (4 listed)
- Parents refusal for the block
- Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
- Skin lesion, wounds or infection at the puncture site.
- Known allergy to local anesthetic drugs
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 Erector Spinae Plane BlockUsing a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane deep to erector spinae muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline and observing the fluid lifting the erector spinae muscle off the transverse process (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the spinous process on a parasagittal plane, to visualize the erector spinae muscle and transverse process, directing the needle craniocaudally using the in-plane technique. The spread of the injectate will be observed to distribute within this plane. | Procedure or surgery | Erector spinae plane block (ESPB) group |
| Ultrasound-guided Quadratus Lumborum BlockUsing a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane between the quadratus lumborum and psoas major muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the L2 spinous process on an axial plane, to visualize the transverse process with psoas major muscle anterior, quadratus lumborum muscle lateral and erector spinae muscle posterior to it. The needle is inserted from the medial side of the probe and advanced laterally using the in-plane technique. The spread of the injectate will be observed to distribute within the target plane. | Procedure or surgery | Quadratus lumborum block (QLB) group |
| Ultrasound MachineSonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer | Device | Erector spinae plane block (ESPB) group, Quadratus lumborum block (QLB) group |
| Echogenic needleA 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA) | Device | Erector spinae plane block (ESPB) group, Quadratus lumborum block (QLB) group |
| FentanylGiven intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes) | Drug | Erector spinae plane block (ESPB) group, Quadratus lumborum block (QLB) group |
| PethidineWill be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6. Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively. | Drug | Erector spinae plane block (ESPB) group, Quadratus lumborum block (QLB) group |
Primary outcome
Time to first postoperative rescue analgesia
Time frame: 12 hours
Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
5 secondary outcomes
Total opioid analgesic consumption in the first 12 hours postoperative period
Time frame: from time of patient transfer to the PACU, till 12 hours postoperatively
Intraoperative mean arterial blood pressure
Time frame: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Intraoperative heart rate
Time frame: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Postoperative pain score
Time frame: from time of patient transfer to the PACU, till 12 hours postoperatively
Block performance time
Time frame: Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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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.
Nevine M Gouda study chair
Cairo University
Sherif M Soaida study chair
Cairo University
Ismail S Hammad study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound-guided Erector Spinae Plane Block, Ultrasound-guided Quadratus Lumborum Block and Ultrasound Machine in people with Postoperative Pain, Acute, run by Cairo University.
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 2 inclusion and 4 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kareem MA Nawwar, M.D. (+201003878369, drknawwar@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first postoperative rescue analgesia (time frame: 12 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 23 May 2022.