Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05442905 |
| Other study ID # |
35565/6/22 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
July 2022 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Multimodal analgesia (MMA) is the current standard practice to provide
postoperative analgesia. The aim of this study is to compare the analgesic efficacy of
quadratus lumborum (QL) block versus transversus abdominis plane (TAP) block versus caudal
block as an adjunct to MMA.
Methods: In a prospective, randomized, controlled study, 180 children of age 2 8 years and
ASA grade Ӏ and ӀӀ, undergoing elective inguinal hernia surgery will be randomly allocated
into 3 groups: Group Q (n = 60) will receive USG guided QL block with 0.7mL/kg of 0.25%
bupivacaine and Group C (n = 60) will receive caudal block with 1mL/kg of 0.25% bupivacaine
and Group T (n = 60) will receive USG guided TAP block with 0.5mL/kg of 0.25% bupivacaine.
Postoperatively, all the subjects will be assessed at 2, 4, 6, 8, 12, 18, and 24 hours. The
primary outcome will be the time to first analgesic request. The secondary outcomes will be
the pain scores during rest and movement, number of doses of morphine, variation in
hemodynamic parameters and adverse effects, if any.
Description:
This prospective, randomized, comparative study will be conducted at Tanta University
Hospitals from August 2022 to March 2023. Total 180 patients of ASA physical status Ӏ ӀӀ,
aged 2-8 years, scheduled for inguinal hernia surgery will be randomized into three groups of
60 patients each, using a computer generated random number table. Exclusion criteria will
include lack of consent by parents, blood coagulopathies, local infection, vertebral
deformity, and allergy to drugs.
Group Q: will receive quadratus lumborum block the patient will be placed in lateral
position, the probe will be placed on the crista iliaca anterior superior. After the external
oblique, internal oblique, and transversus abdominis muscles will be seen, the probe will be
moved to the posterior and the quadratus lumborum muscle will be observed. A 22-gauge, 80 mm
insulated Quince-type needle (Uniplex; Pajunk, Geisingen, Germany) will be moved from the
anterolateral plane to the posteromedial plane, and confirmation will be made using 0.5 mL/kg
saline; after a negative aspiration, 0.7 mL/kg (0.25%) bupivacaine will be applied to the
posterior of the quadratus lumborum muscle and the thoracolumbar fascia in between the
quadratus lumborum and latissimus dorsi muscles.
Patients in: Group T: will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US
guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in
the mid axillary line between the iliac crest and the costal margin. The three layers of
muscles, the external oblique, the internal oblique, and the transversus abdominis will be
identified. Using the in-plane technique, needle will be inserted (from anterior to posterior
direction) until the tip of the needle will reach between the internal oblique and the
transversus abdominis. Hydro dissection with 1-2 mL saline will be done to separate the
fascial layers. After the correct localization, 20 mL of the drug will beinjected with
repeated aspiration to avoid the accidental intravascular injection.
Group C: will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left
lateral position. with all aseptic measures caudal block will be performed using 25 G needle
in left lateral decubitus position. Needle position will be confirmed by the pop felt during
penetration of the sacrococcygeal ligament, further ensured by doing whoosh test using 0.5 mL
of air injection 0.25% bupivacaine 1mL/kg will be administered after negative aspiration of
blood and CSF. Intraoperative hemodynamic parameters will be recorded throughout the surgery
at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).
All patients will be visited 1 day prior to surgery and will be explained about the
anesthesia technique and perioperative course. Each patient will undergo a thorough pre
anesthetic check. On arrival in OT, multipara monitoring of ECG, SpO2, NIBP will be
established. Base line parameters (SpO2 , pulse rate, SBP, DBP) will be recorded. Patient
will be pre medicated with glycopyrrolate 0.005mg/kg, midazolam 0.05mg/kg, and fentanyl
2µg/kg intravenously (IV) through already secured IV line, and ringer lactate infusion will
be started. After pre oxygenation with 100% O2 , anesthesia will be induced with propofol
2-3mg/kg and atracurium 0.6mg/kg; endotracheal intubation will be done using appropriate size
endotracheal tube. Anesthesia will be maintained with O2 :N2 O ratio 40:60 and
sevoflurane(1%-2%) and atracurium 0.15mg/kg SOS. In Group T, patients will be placed in
supine position and the abdomen exposed, skin and transducer will be aseptically prepared.
The abdominal wall will be scanned using a linear array transducer probe(6-13 MHz) in the
multibeam mode, connected to a portable ultrasound unit (S Nerve® SonoSite, Bothell, WA,
USA). Probe will be placed in midline over the rectus abdominis muscle at umbilicus level and
will be traced laterally to region above the iliac crest to the petit triangle. A 22 G short
beveled block needle will be inserted in plane with transducer, in anterior posterior
direction. After visualization of needle tip in between internal oblique and transversus
abdominis fascial sheath, local anesthetic 0.7mL/kg of bupivacaine 0.25% will be deposited.
Correct local anesthetic drug placement will be indicated by hypoechoic elliptical fluid
pocket between these two muscles.
To maintain blinding, postoperative evaluation of pain scores will be done by an
anesthesiologist, who will be not involved in administering block. Postoperative pain will be
assessed by CHEOPS score in which six parameters (cry, facial expression, child verbal,
torso, touch, and leg movements) are included. Duration of postoperative analgesia, total
number of rescue analgesic requirement and total dose of rescue analgesic required in 24h and
any side effects (hypotension, bradycardia, respiratory depression, urinary retention,
postoperative nausea and vomiting) will be recorded. Pain scores ≥ 6 for rescue analgesia in
form of syrup paracetamol 10mg/kg orally will be administered.
