Pain, PostoperativeNCT03811392
Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block in Children
A study testing Hernioraphy/Caudal block and Hernioraphy/Quadratus Lumborum block in people with Pain, Postoperative, run by University of Alexandria at 1 site in Egypt.
Trial summary
To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing postoperative pain, opioid consumption, and recovery time following elective inguinal herniorraphy. The primary outcome: to compare between caudal block and ultrasound guided quadratus lamborum block. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Hernioraphy/Caudal block and Hernioraphy/Quadratus Lumborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 11 Dec 2019
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block for Inguinal Hernioraphy in Preschool Children.
To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing postoperative pain, opioid consumption, and recovery time following elective inguinal herniorraphy.
The primary outcome:
- to compare between caudal block and ultrasound guided quadratus lamborum block.
The secondary outcome:
- duration of postoperative analgesia.
- incidence of postoperative complications.
Read the detailed description
After approval of Ethics Committee of the Faculty of Medicine, and taking a written informed consent from the guardians of each patient, the present study will be carried out in Alexandria Main University Hospitals on 60 patients , aged 2 to 5 years and American Society of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective inguinal herniorraphy in a randomized double blinded study.
The sample size was calculated by High Institute of Public Health.
Exclusion Criteria:
Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal
The patients will be randomly divided by closed envelope technique into two groups:
Group I: 30 patients will receive a caudal block after induction of general anaesthesia.
Group II::Will receive ultrasound guided quadrates lumborum block (QL ) ( posterior transmuscular approach ) using 0.5 mL/kg 0.25% bupivacaine to be applied between the QL muscles and the thoracolumbar fascia. .
METHOD
Preoperative Assessment:
- History taking
- Clinical examination
- Routine laboratory investigations including complete blood picture, bleeding and clotting time, prothrombin time, partial thromboplastin time, blood urea, serum creatinine and fasting blood sugar will be done to every patient.
Pre anaesthetic preparation and premedication
- Nothing per mouth for 6 hours before surgery.
- A peripheral cannula (22 G) will be inserted in all patients.
- Administration 0f 10ml/kg. lactated Ringer's solution.
- All patients will be premedicated with atropine 0,1mg/kg. administered IM to all the patients 30 min prior to surgery.
A multi-channel monitor will be attached to the patient to display:
- Continuous lead II electro cardiogram (ECG) monitoring.
- Non-invasive blood pressure measurement (NIBP) mmHg.
- Arterial oxygen saturation by pulse oximeter (SpO2%).
- End-tidal capnogram (ETco2).
Induction of anesthesia General anesthesia will be induced with sevoflurane and 50% air in oxygen then IV access will be inserted . Fentanyl will be administered at 1 μg/kg, and a laryngeal mask airway will be used to secure the upper airway. Anaesthesia will be maintained with sevoflurane 2% and 50% air in oxygen.
- All procedures (Caudal , QL) will be performed by the same anaesthetist after placement of the LMA before surgery.
- The patients of both groups were admitted to the ward and receive standard postoperative analgesic regimen composed of regular paracetamol 15mg./kg. every 8hours.
According to the studied group, patients will receive after induction either Group I: caudal block. Group II: Quadratus lamborum block.
Technique:
-For the caudal block, the patients were first inducted by GA and then they were placed in the altered left lateral position. The block site, which was mainly at the sacral hiatus, was sterilized with betadine, and the sacral hiatus between the sacral conui was palpated. Then a 23-gage short needle injection was used with the bevel towards the abdomen to puncture the sacral surface at a 45-degree angle. When the sacrococcygeal ligament seemed to have punctured, the needle was tilted more towards the skin surface and the needle was inserted 2-3 mm deeper. The needle was aspired to check for blood and cerebral spinal fluid extravasations. The loss of resistance was confirmed with air-infusion. Then 0.25% bupivacaine 1 ml/kg was infused. (8,9).
In the QL block group, the probe will be placed anterior and superior to the iliac crest, and the 3 abdominal wall muscles will be visualized. The external abdominal oblique muscle will be followed posterolaterally until the posterior border of the muscle will be identified. When the probe is tilted to the attachment site of both the internal abdominal oblique muscle and the external abdominal oblique muscle over the QL, the midline of the thoracolumbar fascia will be seen as a bright hyperechogenic line. A 22-gauge 80-mm Quincke-type SonoPlex needle (Pajunk, Geisingen,Germany) will be inserted using an in-plane technique. The needle will be directed from anterolateral to posteromedial after making a negative aspiration test with 0.5 mL normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 0.5 mL/kg 0.25% bupivacaine will be applied between the QL muscles and the thoracolumbar fascia(10).
The operation will be planned to begin 7 to 10 minutes after the block is applied , and all patients will be operated on with a standardized technique.
Pain levels will be assessed using a FLACC(11) (Face, Legs, Activity, Cry, Consolability ) behavioral pain assessment scale postoperatively . When the FLACC score is 4 or greater ibuprofen 7mg/kg will be administered orally .
Any complications occurring during the procedure will be recorded and treated :
- Hypotension : In childhood, hypotension can be considered significant when there is 20-30% reduction from baseline in systolic blood pressure ( SBP ) (12) . Treated by administering fluid bolus(13) .
- Bradycardia : Defined as(14):
< 60 bpm in kids 3-7 years old . Treated by 0.01-0.02 mg/kg atropine .
- Nausea and vomiting treated with ondansetron 0.1mg/kg intravenously(15) .
MEASURMENTS:
The following parameters will be measured for all patients:
- Pain levels will be assessed using a FLACC (Face, Legs ,Activity, Cry, Consolability) behavioral pain assessment scale postoperatively after recovery at 30minutes and at 1, 2, 4, 6, 12, and24 hours by the nurses and a second anesthetist will be blinded to groupassignment in the recovery room and the surgical ward .
- Duration of analgesia measured by time from start of the block to the first request for analgesia .
- Total analgesic dose .
- Postoperative complications, such as hypotension, arrhythmia, bradycardia,, nausea, or vomiting .
- Parent satisfaction. Satisfaction levels of the parents will be given verbally as a level from 1 to 10, with the lowest level of satisfaction at a value of 1 and the highest level at 10(16).
A-Haemodynamics
- Heart rate (beats/minute) and rhythm.
- Non-invasive mean arterial blood pressure (MABP) in mm Hg. Timing
- Baseline: before the block.
- Just after the block.
- Every 5 min during surgery.
- Every 2 hour after surgery.
B-Need for intraoperative rescue analgesia:
Adequate intraoperative analgesia was defined by hemodynamic stability, as indicated by the absence of an increase in heart rate or systolic arterial pressure 15% compared with baseline values obtained just before surgical incision. An intraoperative increase in blood pressure (BP) or heart rate (HR) by 15% was defined as insufficient analgesia and was treated with a rescue opioid (fentanyl; 1mcg/kg).
C-Assessment of Postoperative analgesia For postoperative pain evaluation, the pain scores were measured and the facial pain scores were taken 10 min, 30 min and 60 min upon arriving into the PACU. The patients were moved to their wards after 90 min passed in the PACU. At 120 min. post-surgery, the last pain scores were taken. The pain scores were taken when the patient was not crying. If the pain score was over 0.6, then paracetamol 15 mg/kg was infused.
D-Analgesic requirements
- Total dose of analgesics postoperative will be recorded
- Time of first analgesic dose given. E-Incidence of postoperative complications: e.g.: nausea , vomiting and respiratory depression.
- Conditions
- Pain, Postoperative
- Being tested
- Hernioraphy/Caudal block, Hernioraphy/Quadratus Lumborum 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.
Hernioraphy/Caudal blockProcedure or surgery
30 patients will receive a caudal block after induction of general anaesthesia
Hernioraphy/Quadratus Lumborum blockProcedure or surgery
30 patients will receive ultrasound guided quadrates lumborum block
| Study group | Role | What they receive |
|---|---|---|
| Hernioraphy/Caudal block | Active comparator | patients will receive a caudal block after induction of general anaesthesia. Receives: Procedure: Hernioraphy/Caudal block |
| Hernioraphy/Quadratus Lumborum block | Active comparator | patients will receive ultrasound guided quadrates lumborum block (QL ) Receives: Procedure: Hernioraphy/Quadratus Lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain.
FLACC Scale from 0 to 10
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Oct 2019
- Primary completion10 Dec 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hazem I. Ahmad Sabry, University of Alexandria
- Investigators
- Mohammad Hazem I Ahmad Sabry, MB,ChB MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811392
- Sponsor's protocol ID
- 050108018(18/12/2018)
- Status last verified
- Dec 2019
- First submitted
- 17 Jan 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meier DE, OlaOlorun DA, Omodele RA, Nkor SK, Tarpley JL. Incidence of umbilical hernia in African children: redefinition of "normal" and reevaluation of indications for repair. World J Surg. 2001 May;25(5):645-8. doi: 10.1007/s002680020072.
PubMed 11369993Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.
PubMed 8867249Johr M. Practical pediatric regional anesthesia. Curr Opin Anaesthesiol. 2013 Jun;26(3):327-32. doi: 10.1097/ACO.0b013e3283606a1e.
PubMed 23614955Hadzic A, Karaca PE, Hobeika P, Unis G, Dermksian J, Yufa M, Claudio R, Vloka JD, Santos AC, Thys DM. Peripheral nerve blocks result in superior recovery profile compared with general anesthesia in outpatient knee arthroscopy. Anesth Analg. 2005 Apr;100(4):976-981. doi: 10.1213/01.ANE.0000150944.95158.B9.
PubMed 15781509Ecoffey C. Local anesthetics in pediatric anesthesia: an update. Minerva Anestesiol. 2005 Jun;71(6):357-60.
PubMed 15886601Willard 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 22630613Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
PubMed 24249997Waldman SD. Caudal epidural nerve block: prone position. In: Atlas of Interventional Pain Management, 2nd edn. Philadelphia: Saunders, 2004 ; 380-92
Machotta A, Risse A, Bercker S, Streich R, Pappert D. Comparison between instillation of bupivacaine versus caudal analgesia for postoperative analgesia following inguinal herniotomy in children. Paediatr Anaesth. 2003 Jun;13(5):397-402. doi: 10.1046/j.1460-9592.2003.01080.x.
PubMed 12791112Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
PubMed 28759502Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
PubMed 9220806Nafiu OO, Voepel-Lewis T, Morris M, Chimbira WT, Malviya S, Reynolds PI, Tremper KK. How do pediatric anesthesiologists define intraoperative hypotension? Paediatr Anaesth. 2009 Nov;19(11):1048-53. doi: 10.1111/j.1460-9592.2009.03140.x. Epub 2009 Oct 1.
PubMed 19796350Pawar D. Common post-operative complications in children. Indian J Anaesth. 2012 Sep;56(5):496-501. doi: 10.4103/0019-5049.103970.
PubMed 23293390Chiu SN, Lin LY, Wang JK, Lu CW, Chang CW, Lin MT, Hua YC, Lue HC, Wu MH. Long-term outcomes of pediatric sinus bradycardia. J Pediatr. 2013 Sep;163(3):885-9.e1. doi: 10.1016/j.jpeds.2013.03.054. Epub 2013 Apr 25.
PubMed 23623512Hohne C. Postoperative nausea and vomiting in pediatric anesthesia. Curr Opin Anaesthesiol. 2014 Jun;27(3):303-8. doi: 10.1097/ACO.0000000000000073.
PubMed 24722005
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block for Inguinal Hernioraphy in Preschool Children.
- ClinicalTrials.gov ID
- NCT03811392
- Acronym / sponsor ID
- 050108018(18/12/2018)
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 22 Jan 2019 (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.
To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing postoperative pain, opioid consumption, and recovery time following elective inguinal herniorraphy.
The primary outcome:
- to compare between caudal block and ultrasound guided quadratus lamborum block.
The secondary outcome:
- duration of postoperative analgesia.
- incidence of postoperative complications.
Detailed description
After approval of Ethics Committee of the Faculty of Medicine, and taking a written informed consent from the guardians of each patient, the present study will be carried out in Alexandria Main University Hospitals on 60 patients , aged 2 to 5 years and American Society of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective inguinal herniorraphy in a randomized double blinded study.
The sample size was calculated by High Institute of Public Health.
Exclusion Criteria:
Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal
The patients will be randomly divided by closed envelope technique into two groups:
Group I: 30 patients will receive a caudal block after induction of general anaesthesia.
Group II::Will receive ultrasound guided quadrates lumborum block (QL ) ( posterior transmuscular approach ) using 0.5 mL/kg 0.25% bupivacaine to be applied between the QL muscles and the thoracolumbar fascia. .
METHOD
Preoperative Assessment:
- History taking
- Clinical examination
- Routine laboratory investigations including complete blood picture, bleeding and clotting time, prothrombin time, partial thromboplastin time, blood urea, serum creatinine and fasting blood sugar will be done to every patient.
Pre anaesthetic preparation and premedication
- Nothing per mouth for 6 hours before surgery.
- A peripheral cannula (22 G) will be inserted in all patients.
- Administration 0f 10ml/kg. lactated Ringer's solution.
- All patients will be premedicated with atropine 0,1mg/kg. administered IM to all the patients 30 min prior to surgery.
A multi-channel monitor will be attached to the patient to display:
- Continuous lead II electro cardiogram (ECG) monitoring.
- Non-invasive blood pressure measurement (NIBP) mmHg.
- Arterial oxygen saturation by pulse oximeter (SpO2%).
- End-tidal capnogram (ETco2).
Induction of anesthesia General anesthesia will be induced with sevoflurane and 50% air in oxygen then IV access will be inserted . Fentanyl will be administered at 1 μg/kg, and a laryngeal mask airway will be used to secure the upper airway. Anaesthesia will be maintained with sevoflurane 2% and 50% air in oxygen.
- All procedures (Caudal , QL) will be performed by the same anaesthetist after placement of the LMA before surgery.
- The patients of both groups were admitted to the ward and receive standard postoperative analgesic regimen composed of regular paracetamol 15mg./kg. every 8hours.
According to the studied group, patients will receive after induction either Group I: caudal block. Group II: Quadratus lamborum block.
Technique:
-For the caudal block, the patients were first inducted by GA and then they were placed in the altered left lateral position. The block site, which was mainly at the sacral hiatus, was sterilized with betadine, and the sacral hiatus between the sacral conui was palpated. Then a 23-gage short needle injection was used with the bevel towards the abdomen to puncture the sacral surface at a 45-degree angle. When the sacrococcygeal ligament seemed to have punctured, the needle was tilted more towards the skin surface and the needle was inserted 2-3 mm deeper. The needle was aspired to check for blood and cerebral spinal fluid extravasations. The loss of resistance was confirmed with air-infusion. Then 0.25% bupivacaine 1 ml/kg was infused. (8,9).
In the QL block group, the probe will be placed anterior and superior to the iliac crest, and the 3 abdominal wall muscles will be visualized. The external abdominal oblique muscle will be followed posterolaterally until the posterior border of the muscle will be identified. When the probe is tilted to the attachment site of both the internal abdominal oblique muscle and the external abdominal oblique muscle over the QL, the midline of the thoracolumbar fascia will be seen as a bright hyperechogenic line. A 22-gauge 80-mm Quincke-type SonoPlex needle (Pajunk, Geisingen,Germany) will be inserted using an in-plane technique. The needle will be directed from anterolateral to posteromedial after making a negative aspiration test with 0.5 mL normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 0.5 mL/kg 0.25% bupivacaine will be applied between the QL muscles and the thoracolumbar fascia(10).
The operation will be planned to begin 7 to 10 minutes after the block is applied , and all patients will be operated on with a standardized technique.
Pain levels will be assessed using a FLACC(11) (Face, Legs, Activity, Cry, Consolability ) behavioral pain assessment scale postoperatively . When the FLACC score is 4 or greater ibuprofen 7mg/kg will be administered orally .
Any complications occurring during the procedure will be recorded and treated :
- Hypotension : In childhood, hypotension can be considered significant when there is 20-30% reduction from baseline in systolic blood pressure ( SBP ) (12) . Treated by administering fluid bolus(13) .
- Bradycardia : Defined as(14):
< 60 bpm in kids 3-7 years old . Treated by 0.01-0.02 mg/kg atropine .
- Nausea and vomiting treated with ondansetron 0.1mg/kg intravenously(15) .
MEASURMENTS:
The following parameters will be measured for all patients:
- Pain levels will be assessed using a FLACC (Face, Legs ,Activity, Cry, Consolability) behavioral pain assessment scale postoperatively after recovery at 30minutes and at 1, 2, 4, 6, 12, and24 hours by the nurses and a second anesthetist will be blinded to groupassignment in the recovery room and the surgical ward .
- Duration of analgesia measured by time from start of the block to the first request for analgesia .
- Total analgesic dose .
- Postoperative complications, such as hypotension, arrhythmia, bradycardia,, nausea, or vomiting .
- Parent satisfaction. Satisfaction levels of the parents will be given verbally as a level from 1 to 10, with the lowest level of satisfaction at a value of 1 and the highest level at 10(16).
A-Haemodynamics
- Heart rate (beats/minute) and rhythm.
- Non-invasive mean arterial blood pressure (MABP) in mm Hg. Timing
- Baseline: before the block.
- Just after the block.
- Every 5 min during surgery.
- Every 2 hour after surgery.
B-Need for intraoperative rescue analgesia:
Adequate intraoperative analgesia was defined by hemodynamic stability, as indicated by the absence of an increase in heart rate or systolic arterial pressure 15% compared with baseline values obtained just before surgical incision. An intraoperative increase in blood pressure (BP) or heart rate (HR) by 15% was defined as insufficient analgesia and was treated with a rescue opioid (fentanyl; 1mcg/kg).
C-Assessment of Postoperative analgesia For postoperative pain evaluation, the pain scores were measured and the facial pain scores were taken 10 min, 30 min and 60 min upon arriving into the PACU. The patients were moved to their wards after 90 min passed in the PACU. At 120 min. post-surgery, the last pain scores were taken. The pain scores were taken when the patient was not crying. If the pain score was over 0.6, then paracetamol 15 mg/kg was infused.
D-Analgesic requirements
- Total dose of analgesics postoperative will be recorded
- Time of first analgesic dose given. E-Incidence of postoperative complications: e.g.: nausea , vomiting and respiratory depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hernioraphy/Caudal block | Active comparator | Procedure: Hernioraphy/Caudal blockpatients will receive a caudal block after induction of general anaesthesia. |
| Hernioraphy/Quadratus Lumborum block | Active comparator | Procedure: Hernioraphy/Quadratus Lumborum blockpatients will receive ultrasound guided quadrates lumborum block (QL ) |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal
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 |
|---|---|---|
| Hernioraphy/Caudal block30 patients will receive a caudal block after induction of general anaesthesia | Procedure or surgery | Hernioraphy/Caudal block |
| Hernioraphy/Quadratus Lumborum block30 patients will receive ultrasound guided quadrates lumborum block | Procedure or surgery | Hernioraphy/Quadratus Lumborum block |
Primary outcome
Postoperative pain.
Time frame: 24 hours
FLACC Scale from 0 to 10
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 2 Jan 2020.
- Background: PubMed 11369993Meier DE, OlaOlorun DA, Omodele RA, Nkor SK, Tarpley JL. Incidence of umbilical hernia in African children: redefinition of "normal" and reevaluation of indications for repair. World J Surg. 2001 May;25(5):645-8. doi: 10.1007/s002680020072.
- Background: PubMed 8867249Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.
- Background: PubMed 23614955Johr M. Practical pediatric regional anesthesia. Curr Opin Anaesthesiol. 2013 Jun;26(3):327-32. doi: 10.1097/ACO.0b013e3283606a1e.
- Background: PubMed 15781509Hadzic A, Karaca PE, Hobeika P, Unis G, Dermksian J, Yufa M, Claudio R, Vloka JD, Santos AC, Thys DM. Peripheral nerve blocks result in superior recovery profile compared with general anesthesia in outpatient knee arthroscopy. Anesth Analg. 2005 Apr;100(4):976-981. doi: 10.1213/01.ANE.0000150944.95158.B9.
- Background: PubMed 15886601Ecoffey C. Local anesthetics in pediatric anesthesia: an update. Minerva Anestesiol. 2005 Jun;71(6):357-60.
- 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 24249997Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
- BackgroundWaldman SD. Caudal epidural nerve block: prone position. In: Atlas of Interventional Pain Management, 2nd edn. Philadelphia: Saunders, 2004 ; 380-92
- Background: PubMed 12791112Machotta A, Risse A, Bercker S, Streich R, Pappert D. Comparison between instillation of bupivacaine versus caudal analgesia for postoperative analgesia following inguinal herniotomy in children. Paediatr Anaesth. 2003 Jun;13(5):397-402. doi: 10.1046/j.1460-9592.2003.01080.x.
- Background: PubMed 28759502Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
- Background: PubMed 9220806Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Background: PubMed 19796350Nafiu OO, Voepel-Lewis T, Morris M, Chimbira WT, Malviya S, Reynolds PI, Tremper KK. How do pediatric anesthesiologists define intraoperative hypotension? Paediatr Anaesth. 2009 Nov;19(11):1048-53. doi: 10.1111/j.1460-9592.2009.03140.x. Epub 2009 Oct 1.
- Individual participant dataSharing planned: No
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Cesarean Section
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.
Mohammad Hazem I Ahmad Sabry, MB,ChB MD principal investigator
Alexandria 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 Hernioraphy/Caudal block and Hernioraphy/Quadratus Lumborum block in people with Pain, Postoperative, run by University of Alexandria 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 0 inclusion and 1 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 2 Jan 2020. 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?
Postoperative pain. (time frame: 24 hours). 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 NCT03811392, which also lists 16 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 2 Jan 2020.