Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05466500 |
| Other study ID # |
N-53-2022 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 26, 2022 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Kasr El Aini Hospital |
| Contact |
Ahmed nabih, lecturer |
| Phone |
01002773488 |
| Email |
nabihomar100[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Postoperative pain is a common manifestation in orthopedic patients, mainly due to
intraoperative tissue damage , inadequate intraoperative pain assessment and management.
Axillary nerve block provides motor and sensory block with the distribution of the median,
radial, ulnar and musculocutaneous branches so it can be conducted with upper limb orthopedic
surgery in hand, rest and elbow surgery distal to the cubital fossa.Sensory blockade of the
brachial plexus for perioperative analgesia leads to stable haemodynamics intraoperatively,
smoother emergence from general anaesthesia and decreased need for supplemental analgesics or
suppositories in the Post-operative period Intravenous (IV) dexamethasone has been used as an
additive to local anesthetic for peripheral nerve blocks (PNBs) in adults with variable
efficacy.To the best of our knowledge the efficacy of intravenous dexamethasone as adjuvant
to bupivacaine in ultrasound guided axillary brachial plexus block in pediatrics has not been
investigated
In this study the investigators will assess the analgesic effect of adding intravenous
dexamethasone to bupivacaine in ultrasound guided axillary block in children undergoing upper
limb orthopedic surgeries.
Objectives:
- To determine the effect of adding intravenous dexamethasone on the duration of analgesia
.
- To determine the effect of adding intravenousdexamethasone on quality of analgesia
Description:
This a randomized control trial is designed to include (60) patients ASA physical statusI-II
patients ranging from(4) to(14)years old scheduled for upper limb orthopaedic surgery in the
hand, wrist, and elbow distal to the cubital fossa.
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group A :Axillary block with 2 mg/kg of 0.25% bupivacaine. (n=30) Group B: Axillary block
with 2 mg/kg of 0.25% bupivacaine plus 0.1mg/kg dexamethasone intravenous:(n=30)
All children will be anaesthetized in accordance with the local policy of the Abu El-Reesh
pediatric hospital-Cairo university's pediatric anaesthetic unit. Except for oral clear
liquids intake 2 hours before surgery, all children will fast for 6 hours. Patients will
attend in the preparation room one hour before the operation to get a preoperative checkup,
as well as their age and body weight will be recorded. Pre medicated by intramuscular
injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg before insertion of intravenous
(I.V) cannula.On arriving the operating room, heart rate (HR) ,oxygen saturation and
non-invasive blood pressure will be continuously recorded, using standard monitor (Dräger
infinity vista XL).
All patients will be induced with propofol 2 mg / kg , atracurium 0.5mg/kg and fentanyl
1μg/kg, then the patients will be intubated by appropriate size of endotracheal tube volume
control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2
levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine.
Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, with the goal of
keeping the BIS measurement between (40-60), and atracurium top-ups of 0.1mg/kg will be given
every 30 minutes for neuromuscular blockade.Then the block will be conducted after general
anesthesia by an expert anesthesiologist who is different from the anesthesiologist who
provided anesthesia to the patient.
Axillary block
Axillary nerve block will be induced with patient in supine under GA with ultrasound SonoSite
M Turbo (USA), the scanning probe will be the linear multi-frequency 6-13 MHz transducer (L25
x 6-13 MHz linear array).The probe will be protected with sterile cover, antiseptic betadine
will be applied to the site of block injection , the operating arm will be abducted by 70
externally rotated, and the elbow will be flexed to ~90. Within the axillary crease the probe
position will be placed sagittal where bounded by the pectoralis major antero-medially and
the latissimus dorsi and teres major posteromedial.
The probe will be placed parallel to the anterior axillary fold at the axilla to identify the
axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation
to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral
side of the forearm had to be blocked also. It is found between the biceps brachii and
coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and
directed toward the posterior aspect of the axillary artery. All four nerves in the axillary
region will be blocked. The block will be applied by 50-mm block needle 22 gauge at cephalic
side of the probe. The same volume of local anesthetic will be used in each group with 2
mg/kg of 0.25% bupivacaine. Group A will receive 2ml of saline solution i.v after completing
the block,Group B will receive 0.1mg/kg dexamethasone i.v after completing the block.
The time passed between the entrance of the needle into the skin and the injection's
completion is referred to as axillary block performance time.The end of the local anesthetic
solution injection will be considered the time zero to assess the blockade effectiveness. The
surgical procedure will be start after 15-20 min.
If there is an increase in heart rate or mean arterial blood pressure of more than 20% of the
baseline value after skin incision then it will be considered asblock failure and these
patients will be excluded from the study. 1-2ug/kg intravenous fentanyl will be given to
failed block. At the end of surgery,residual neuromuscular block will be antagonized with IV
neostigmine 0.05 mg/kg and atropine 0.02mg/kg. All patients will receive 15mg/kg paracetamol
IV every 6 hours.
Postoperative
1. The postoperative pain assessment in the PACU and the wardwill be performed using a
(FLACC score)(APPENDIX 1)(10).Patients will be assessed immediately postoperatively and
then at 1st, 4th, 8th, 12th , 24 hour post-operatively.Patients with pain score more
than 3\10 ,Pethidine I.V will be given as rescue analgesic (1 mg/kg) when needed.The
time to first request of postoperative analgesic is defined as( the time interval from
LA injection to first dose of pethidine adminstration) will be recorded. The total
amount of pethidine in the first postoperative 24 hours will be calculated in both
groups.
2. Block related complications will be recorded such as failed block, local anaesthetic
toxicity, vascular puncture, paresthesia.
Measurement tools
1. Patients demographic data will be collected; age, gender, height,weight , type and
duration of surgery
2. Block time duration, Surgical procedure , duration and Axillary block performance time.
3. Intraoperative haemodynamic (Heart rate ,systolic and diastolic blood
pressure)pre-induction , post-intubation , post-block , immediate post skin incision ,
every 15 minutes.
4. Postoperative pain assessments using(FLACC score)at at 0 point 1hr, 4hr, 8hr ,12 hr, and
at 24 hr
5. Time to first request of rescue postoperative analgesic
6. Total opioid consumption in 24h postoperative
7. Tourniquet whether used or not and if used time and pressure will be recorded
