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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Alexandria Faculty of Medicine

    Alexandria, 21111

Other trials in Egypt

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:

  1. History taking
  2. Clinical examination
  3. 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:

  1. Continuous lead II electro cardiogram (ECG) monitoring.
  2. Non-invasive blood pressure measurement (NIBP) mmHg.
  3. Arterial oxygen saturation by pulse oximeter (SpO2%).
  4. 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

  1. Heart rate (beats/minute) and rhythm.
  2. 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.
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 groups in NCT03811392
Study groupRoleWhat they receive
Hernioraphy/Caudal blockActive comparatorpatients will receive a caudal block after induction of general anaesthesia.
Receives: Procedure: Hernioraphy/Caudal block
Hernioraphy/Quadratus Lumborum blockActive comparatorpatients 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.

  1. 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.

  1. First posted22 Jan 2019
  2. Study start1 Oct 2019
  3. Primary completion10 Dec 2019
  4. Study completion11 Dec 2019

Resources

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)
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 11369993
  • Finley 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 8867249
  • Johr M. Practical pediatric regional anesthesia. Curr Opin Anaesthesiol. 2013 Jun;26(3):327-32. doi: 10.1097/ACO.0b013e3283606a1e.

    PubMed 23614955
  • Hadzic 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 15781509
  • Ecoffey C. Local anesthetics in pediatric anesthesia: an update. Minerva Anestesiol. 2005 Jun;71(6):357-60.

    PubMed 15886601
  • Willard 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 22630613
  • Kadam 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 24249997
  • Waldman 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 12791112
  • Oksuz 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 28759502
  • Merkel 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 9220806
  • Nafiu 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 19796350
  • Pawar D. Common post-operative complications in children. Indian J Anaesth. 2012 Sep;56(5):496-501. doi: 10.4103/0019-5049.103970.

    PubMed 23293390
  • Chiu 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 23623512
  • Hohne C. Postoperative nausea and vomiting in pediatric anesthesia. Curr Opin Anaesthesiol. 2014 Jun;27(3):303-8. doi: 10.1097/ACO.0000000000000073.

    PubMed 24722005

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.

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