Pain, PostoperativeNCT03646630
Quadratus Lumborum Block Versus Caudal Block for Pediatric Postoperative Analgesia
A study testing Quadratus Lumborum Block and Caudal Block in people with Pain, Postoperative, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
The aim of this study is to compare between two regional analgesic techniques; caudal block and ultrasound guided quadratus lumborum block as regard degree of pain relief, accuracy of block, effect on hemodynamic stability and incidence of complications. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Quadratus Lumborum Block and Caudal Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2019to 15 Oct 2020
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-7 years
- American Society of Anesthesiologists physical status I-II
- Lower abdominal surgery
Who cannot join
- History of developmental delay or mental retardation
- Parent refusal
- History of allergic reactions to local anesthetics
- Rash or infection at the injection site
- Anatomical abnormality
- Bleeding disorders.
- History of cardiac, neurological, renal, hepatic diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, 63514
About this study
Official title: Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block for Pain Relief in Children Undergoing Lower Abdominal Surgeries
The aim of this study is to compare between two regional analgesic techniques; caudal block and ultrasound guided quadratus lumborum block as regard degree of pain relief, accuracy of block, effect on hemodynamic stability and incidence of complications.
Read the detailed description
Regional anesthesia and analgesia techniques are commonly used during pediatric surgical practice to facilitate pain control, decrease parenteral opioid requirements and improve the quality of post-operative pain control and patient-parent satisfaction. The most commonly used technique is caudal anesthesia, which is generally indicated for urologic surgery, inguinal hernia repair and lower extremity surgery. The quadratus lumborum (QL) block is a recently introduced abdominal truncal block, used for somatic and visceral analgesia of both the upper and lower abdomen. It was first described by Blanco in 2007 . Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery . QL block allows the local anesthetics to spread between the posterior aspect of the quadratus lumborum muscle and the medial layer of the thoracolumbar fascia, which is close to the thoracic paravertebral space .
The ultrasound (US) has gained popularity among anesthesiologists performing regional anesthesia. Block success, and hence the efficacy would depend on the patient's anatomical variations and the anesthesiologist's skill level .
The use of ultrasound-guidance for peripheral nerve blocks (PNBs) offers many advantages. Direct visualization of the nervous and surrounding structures decreases the incidence of complications e.g. inadvertent intraneural or intravascular injection. Direct real-time observation of the local anesthetics spread ensures more accurate deposition .This leads to faster onset and longer duration of block, thus improves block quality. It also allows dose reduction of local anesthetics . It has been shown that when peripheral nerves are adequately imaged by ultrasound, the simultaneous use of the nerve stimulator offers no further advantages.
Following ethical committee approval of Anesthesia department, Fayoum University and obtaining informed consent from parents of each patient, fifty two patients will be randomized into 2 study groups. Each group contains 26 patients.
Methodology:
Preoperative Assessment:
All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications.
Operating Room Preparation \& Equipment:
The ultrasound used will be Sonosite M Turbo (USA), the scanning probe will be the linear multi-frequency 13-6 MHz transducer (L25x13-6 MHz linear array). The needle used will be the stimuplex D needles manufactured by B Braun (Germany).
Perioperative Management:
All patients will be premedicated with IM midazolam 0.2 mg/kg and atropine 0.02 mg/kg. Perioperative monitoring will include continuous ECG, pulse oximetry, non-invasive arterial blood pressure, and temperature monitoring.
Inhalational induction of general anesthesia (GA) will be performed with a face mask using sevoflurane 8% and 50% oxygen in air, and then an intravenous (IV) cannula will be inserted. Fentanyl will be administered intravenously at 1 μg/kg, and a laryngeal mask airway (Intavent - Orthofix, Maidenhead, United Kingdom) will be used to secure the upper airway, with the patient kept spontaneously breathing. Anesthesia will be maintained with Isoflurane and 50% oxygen in air.
Surgery will be allowed to begin 10 minutes after block application. At the end of surgery, acetaminophen 15 mg/kg IV will be administered to all patients. Any complications occurring during the procedure will be recorded.
After completion of surgical procedure and emergence from anesthesia the patient will be referred to PACU. Quality of analgesia will be assessed using a FLACC scale at 30 minutes and at 1, 2, 4, 6, 12, and 24 hours postoperatively. Diclofenac sodium 1 mg/kg rectally will be given as rescue analgesia for patients in all study groups in PACU if FLACC scale > 4. Parents will be informed about the pain evaluation, and when patients had pain at home, parents will be instructed to give oral paracetamol 30 mg/kg. The anesthesiologist will record data received from the parents over the phone.
Statistical Analysis Sample size was calculated using the G* Power software version 3.1.7 analysis program (Heinirch Heine University, Dusseldorf, Germany) before the study. Depending on previous similar research with calculated effect size (d) 0.85, two tails (two sided), type 1 error 0.05 and increasing power of study to 90%, it was determined that each group should include at least 26 subject to obtain significant statistical value.
Collected data will be computerized and analyzed using statistical package for social science (SPSS) version 16. The results will be expressed as number and percentages for qualitative variables, mean, standard deviation and range for continuous data, median and inter-quartile range for quantitative discrete variables and scores.
To compare between groups, the chi-square will be used for qualitative variables, student t rest for comparing quantitative continuous variables between 2 groups, Mann Whitney U test to compare scores between 2 groups. Probability (P) value of less than 0.05 will be considered statistically significant.
- Conditions
- Pain, Postoperative
- Being tested
- Quadratus Lumborum Block, Caudal Block
- Keywords
- lower abdominal surgeries, quadratus lumborum block, caudal block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum BlockProcedure or surgery
Posterior or QL block type 2 , a bolus of 0.5 ml/Kg bupivacaine 0.25%
Caudal BlockProcedure or surgery
caudal block with 1 ml/kg of bupivacaine 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block (QL) | Active comparator | Patients will be placed in the lateral position,The high-frequency linear probe will be placed on the lateral abdomen, slightly cephalic to the iliac crest. Once the QL muscle will be observed, the probe will be tilted slightly to the caudal direction, to show the largest slice of the QL muscle, to confirm its posterior aspect. A 22-G block needle (Stimuplex D, Braun, Hongo, Bunkyo-ku, and Tokyo) will be inserted in-plane, ~1 cm ventral to the probe. The needle tip will be advanced until it penetrates the posterior fascia of the QL muscle. A small amount of saline will be injected to confirm the correct position of the tip, between the QL muscle and the erector spinae and latissimus dorsi muscles (Posterior or QL block type 2), then a bolus of 0.5 ml/Kg bupivacaine 0.25% will be injected. Receives: Procedure: Quadratus Lumborum Block |
| Caudal block (C) | Active comparator | After induction of general anesthesia, a lateral position is obtained with the upper hip flexed 90⁰ and the lower one only 45⁰. A line is drawn to connect the posterior superior iliac spines bilaterally and used as one side of an equilateral triangle; then the location of the sacral hiatus should be approximated. By palpating the sacral cornua as 2 bony prominences, the sacral hiatus could be identified as a dimple in between. A 22 gauge needle is inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone is contacted. Children will receive caudal block with 1 ml/kg of bupivacaine 0.25%. Receives: Procedure: Caudal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time at which the first analgesia required
in hours
Measured: 24 hours after procedure
Secondary outcomes (23)
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Measured: 30 minutes after operation
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Measured: 1 hour after operation
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Measured: 2 hours after operation
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Measured: 4 hours after operation
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Measured: 6 hours after operation
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Measured: 12 hours after operation
Pain assessment by the aid of FLACC score
F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score
Measured: 24 hours after operation
number of analgesic doses for each patient
by oral paracetamol 30 mg/kg given by parents
Measured: 24 hours after operation
The general satisfaction score of parents
measured on a 5-point scale of 1.Extremely dissatisfied 2.Dissatisfied 3.Not satisfied, nor dissatisfied 4.Satisfied 5.Completely satisfied.
Measured: 24 hours after operation
Preoperative heart rate
in beat per minutes measured by electrocardiogram
Measured: 5 minutes before operation
Preoperative systolic blood pressure
in mm mercury measured by non-invasive blood pressure measurement
Measured: 5 minutes before operation
Preoperative diastolic blood pressure
in mm mercury measured by non-invasive blood pressure measurement
Measured: 5 minutes before operation
Intraoperative systolic blood pressure
in mm mercury measured by non-invasive blood pressure measurement
Measured: every 15 minutes till end of operation
Intraoperative diastolic blood pressure
in mm mercury measured by non-invasive blood pressure measurement
Measured: every 15 minutes till end of operation
Intraoperative heart rate
in beat per minutes measured by electrocardiogram
Measured: every 15 minutes till end of operation
Incidence of hypotension
drop of blood pressure more than 20 % of baseline blood pressure
Measured: within one hour of the intervention
Incidence of bradycardia
Heart rate below 50 beat per minute by electrocardiogram
Measured: Within one hour of the intervention
Incidence of vascular puncture
as signs of local anesthetics toxicity
Measured: Within one hour of the intervention
Incidence of convulsions
as signs of local anesthetics toxicity
Measured: Within one hour of the intervention
Incidence of arrhythmias
as signs of local anesthetics toxicity
Measured: Within one hour of the intervention
Incidence of paresthesia
as signs of local anesthetics toxicity
Measured: Within one hour of the intervention
Incidence of hematoma formation
Recorded under ultrasound guidance
Measured: Within one hour of the intervention
Incidence of injury to the underlying structures
Injury to the liver or a viscous
Measured: Within one hour of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start2 May 2019
- Primary completion1 Aug 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Doaa Lotfy, Fayoum University Hospital
- Investigators
- Kareem M Nawwar, MD, Study director, Kasr ElAini Hospital, Faculty Of Medicine, Cairo Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646630
- Sponsor's protocol ID
- D141
- Status last verified
- Sep 2022
- First submitted
- 1 Aug 2018
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
PubMed 11460814Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.
PubMed 22630613Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.
PubMed 25642956Liu SS, Ngeow J, John RS. Evidence basis for ultrasound-guided block characteristics: onset, quality, and duration. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S26-35. doi: 10.1097/AAP.0b013e3181d266f0.
PubMed 20216022Griffin J, Nicholls B. Ultrasound in regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:1-12. doi: 10.1111/j.1365-2044.2009.06200.x.
PubMed 20377542
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
- Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block for Pain Relief in Children Undergoing Lower Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT03646630
- Acronym / sponsor ID
- D141
- Conditions
- Pain, Postoperative
- Keywords
- lower abdominal surgeries, quadratus lumborum block, caudal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 2 May 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 24 Aug 2018 (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 aim of this study is to compare between two regional analgesic techniques; caudal block and ultrasound guided quadratus lumborum block as regard degree of pain relief, accuracy of block, effect on hemodynamic stability and incidence of complications.
Detailed description
Regional anesthesia and analgesia techniques are commonly used during pediatric surgical practice to facilitate pain control, decrease parenteral opioid requirements and improve the quality of post-operative pain control and patient-parent satisfaction. The most commonly used technique is caudal anesthesia, which is generally indicated for urologic surgery, inguinal hernia repair and lower extremity surgery. The quadratus lumborum (QL) block is a recently introduced abdominal truncal block, used for somatic and visceral analgesia of both the upper and lower abdomen. It was first described by Blanco in 2007 . Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery . QL block allows the local anesthetics to spread between the posterior aspect of the quadratus lumborum muscle and the medial layer of the thoracolumbar fascia, which is close to the thoracic paravertebral space .
The ultrasound (US) has gained popularity among anesthesiologists performing regional anesthesia. Block success, and hence the efficacy would depend on the patient's anatomical variations and the anesthesiologist's skill level .
The use of ultrasound-guidance for peripheral nerve blocks (PNBs) offers many advantages. Direct visualization of the nervous and surrounding structures decreases the incidence of complications e.g. inadvertent intraneural or intravascular injection. Direct real-time observation of the local anesthetics spread ensures more accurate deposition .This leads to faster onset and longer duration of block, thus improves block quality. It also allows dose reduction of local anesthetics . It has been shown that when peripheral nerves are adequately imaged by ultrasound, the simultaneous use of the nerve stimulator offers no further advantages.
Following ethical committee approval of Anesthesia department, Fayoum University and obtaining informed consent from parents of each patient, fifty two patients will be randomized into 2 study groups. Each group contains 26 patients.
Methodology:
Preoperative Assessment:
All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications.
Operating Room Preparation \& Equipment:
The ultrasound used will be Sonosite M Turbo (USA), the scanning probe will be the linear multi-frequency 13-6 MHz transducer (L25x13-6 MHz linear array). The needle used will be the stimuplex D needles manufactured by B Braun (Germany).
Perioperative Management:
All patients will be premedicated with IM midazolam 0.2 mg/kg and atropine 0.02 mg/kg. Perioperative monitoring will include continuous ECG, pulse oximetry, non-invasive arterial blood pressure, and temperature monitoring.
Inhalational induction of general anesthesia (GA) will be performed with a face mask using sevoflurane 8% and 50% oxygen in air, and then an intravenous (IV) cannula will be inserted. Fentanyl will be administered intravenously at 1 μg/kg, and a laryngeal mask airway (Intavent - Orthofix, Maidenhead, United Kingdom) will be used to secure the upper airway, with the patient kept spontaneously breathing. Anesthesia will be maintained with Isoflurane and 50% oxygen in air.
Surgery will be allowed to begin 10 minutes after block application. At the end of surgery, acetaminophen 15 mg/kg IV will be administered to all patients. Any complications occurring during the procedure will be recorded.
After completion of surgical procedure and emergence from anesthesia the patient will be referred to PACU. Quality of analgesia will be assessed using a FLACC scale at 30 minutes and at 1, 2, 4, 6, 12, and 24 hours postoperatively. Diclofenac sodium 1 mg/kg rectally will be given as rescue analgesia for patients in all study groups in PACU if FLACC scale > 4. Parents will be informed about the pain evaluation, and when patients had pain at home, parents will be instructed to give oral paracetamol 30 mg/kg. The anesthesiologist will record data received from the parents over the phone.
Statistical Analysis Sample size was calculated using the G* Power software version 3.1.7 analysis program (Heinirch Heine University, Dusseldorf, Germany) before the study. Depending on previous similar research with calculated effect size (d) 0.85, two tails (two sided), type 1 error 0.05 and increasing power of study to 90%, it was determined that each group should include at least 26 subject to obtain significant statistical value.
Collected data will be computerized and analyzed using statistical package for social science (SPSS) version 16. The results will be expressed as number and percentages for qualitative variables, mean, standard deviation and range for continuous data, median and inter-quartile range for quantitative discrete variables and scores.
To compare between groups, the chi-square will be used for qualitative variables, student t rest for comparing quantitative continuous variables between 2 groups, Mann Whitney U test to compare scores between 2 groups. Probability (P) value of less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block (QL) | Active comparator | Procedure: Quadratus Lumborum BlockPatients will be placed in the lateral position,The high-frequency linear probe will be placed on the lateral abdomen, slightly cephalic to the iliac crest. Once the QL muscle will be observed, the probe will be tilted slightly to the caudal direction, to show the largest slice of the QL muscle, to confirm its posterior aspect. A 22-G block needle (Stimuplex D, Braun, Hongo, Bunkyo-ku, and Tokyo) will be inserted in-plane, ~1 cm ventral to the probe. The needle tip will be advanced until it penetrates the posterior fascia of the QL muscle. A small amount of saline will be injected to confirm the correct position of the tip, between the QL muscle and the erector spinae and latissimus dorsi muscles (Posterior or QL block type 2), then a bolus of 0.5 ml/Kg bupivacaine 0.25% will be injected. |
| Caudal block (C) | Active comparator | Procedure: Caudal BlockAfter induction of general anesthesia, a lateral position is obtained with the upper hip flexed 90⁰ and the lower one only 45⁰. A line is drawn to connect the posterior superior iliac spines bilaterally and used as one side of an equilateral triangle; then the location of the sacral hiatus should be approximated. By palpating the sacral cornua as 2 bony prominences, the sacral hiatus could be identified as a dimple in between. A 22 gauge needle is inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone is contacted. Children will receive caudal block with 1 ml/kg of bupivacaine 0.25%. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1-7 years
- American Society of Anesthesiologists physical status I-II
- Lower abdominal surgery
Key exclusion criteria (7 listed)
- History of developmental delay or mental retardation
- Parent refusal
- History of allergic reactions to local anesthetics
- Rash or infection at the injection site
- Anatomical abnormality
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 |
|---|---|---|
| Quadratus Lumborum BlockPosterior or QL block type 2 , a bolus of 0.5 ml/Kg bupivacaine 0.25% | Procedure or surgery | Quadratus Lumborum Block (QL) |
| Caudal Blockcaudal block with 1 ml/kg of bupivacaine 0.25%. | Procedure or surgery | Caudal block (C) |
Primary outcome
Time at which the first analgesia required
Time frame: 24 hours after procedure
in hours
23 secondary outcomes
Pain assessment by the aid of FLACC score
Time frame: 30 minutes after operation
Pain assessment by the aid of FLACC score
Time frame: 1 hour after operation
Pain assessment by the aid of FLACC score
Time frame: 2 hours after operation
Pain assessment by the aid of FLACC score
Time frame: 4 hours after operation
Pain assessment by the aid of FLACC score
Time frame: 6 hours after operation
Pain assessment by the aid of FLACC score
Time frame: 12 hours after operation
Pain assessment by the aid of FLACC score
Time frame: 24 hours after operation
number of analgesic doses for each patient
Time frame: 24 hours after operation
The general satisfaction score of parents
Time frame: 24 hours after operation
Preoperative heart rate
Time frame: 5 minutes before operation
Preoperative systolic blood pressure
Time frame: 5 minutes before operation
Preoperative diastolic blood pressure
Time frame: 5 minutes before operation
Intraoperative systolic blood pressure
Time frame: every 15 minutes till end of operation
Intraoperative diastolic blood pressure
Time frame: every 15 minutes till end of operation
Intraoperative heart rate
Time frame: every 15 minutes till end of operation
Incidence of hypotension
Time frame: within one hour of the intervention
Incidence of bradycardia
Time frame: Within one hour of the intervention
Incidence of vascular puncture
Time frame: Within one hour of the intervention
Incidence of convulsions
Time frame: Within one hour of the intervention
Incidence of arrhythmias
Time frame: Within one hour of the intervention
Incidence of paresthesia
Time frame: Within one hour of the intervention
Incidence of hematoma formation
Time frame: Within one hour of the intervention
Incidence of injury to the underlying structures
Time frame: Within one hour of the intervention
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.
- Background: PubMed 11460814Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
- Background: PubMed 22630613Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.
- Background: PubMed 25642956Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.
- Background: PubMed 20216022Liu SS, Ngeow J, John RS. Evidence basis for ultrasound-guided block characteristics: onset, quality, and duration. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S26-35. doi: 10.1097/AAP.0b013e3181d266f0.
- Background: PubMed 20377542Griffin J, Nicholls B. Ultrasound in regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:1-12. doi: 10.1111/j.1365-2044.2009.06200.x.
- Individual participant dataSharing planned: Undecided
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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.
Kareem M Nawwar, MD study director
Kasr ElAini Hospital, Faculty Of Medicine, Cairo Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum Block and Caudal Block in people with Pain, Postoperative, 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 3 inclusion and 7 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?
Time at which the first analgesia required (time frame: 24 hours after procedure). 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 NCT03646630, which also lists 5 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 7 Sep 2022.