Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02984800 |
| Other study ID # |
3122016 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
April 2022 |
Study information
| Verified date |
January 2022 |
| Source |
Makassed General Hospital |
| Contact |
Zoher Naja, MD |
| Email |
zouhnaja[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Paravertebral block (PVB) might be a technique of choice for hernia surgery due to its
unilateral segmental anesthesia of the operative site, good muscle relaxation and prolonged
postoperative analgesia. Despite PVB effectiveness, a continuing search for a reliable,
timely and effective technique generates the investigation of a single PVB injection for
children undergoing unilateral inguinal hernia repair. Two theoretical concepts were behind
this investigation. First, possible spread of single PVB injection in the lumbar area over
dermatomes corresponding to the inguinal hernia region in children likewise the spread over
multiple adjacent segments from a single thoracic PVB injection. Second, as the inguinal
region receives innervation from the ilioinguinal, iliohypogastric and genitofemoral nerves,
all three arising from L1-L2 level; thus, a single PVB injection at this level could provide
unilateral segmental anesthesia.
Description:
The study will be conducted prospectively, using a randomized double-blinded design. Male
patients scheduled for elective unilateral herniorrhaphy will be included in the study.
Patients will be randomly allocated into two groups using the sealed envelope technique. All
patients will have inhaled induction of anesthesia by facemask using oxygen and 8%
sevoflurane for 2 to 4 minutes followed by placement of an IV cannula. After performing PVB
injections, the sevoflurane concentration will be decreased to 0.4% to 0.8% and maintained
until completion of surgery.
Then, group I will receive one PVB injection at L1-L2 and placebo PVB injections at T12-L1
and L2-L3. Group III will receive three PVB injections at T12-L1, L1-L2 and L2-L3.
Paravertebral block technique After induction of anesthesia and placement of regular
anesthetic monitors, three unilateral PVBs will be performed with the child lying in the
lateral position with the operative side uppermost. The needle insertion sites will be
1.5-2.0 cm lateral to the midline depending on the age and the body mass index of the child.
After aseptic preparation of the skin, a nerve stimulator (Stimuplex, B Braun AG, Melsungen,
Germany) is used to identify an evoked muscular contraction appropriate for the levels. A 50
mm 21G insulated needle (Stimuplex A, B Braun AG) will be introduced perpendicular to the
skin using 5 mA and 1 Hz. Then, the stimulating needle is gently manipulated to allow for
adequate muscle response with a stimulating current of 0.4-0.6 mA.
In order to preserve the double-blindness of this trial, an independent nurse will prepare
three syringes. Each syringe is labeled with the corresponding level of injection i.e,
T12-L1, L1-L2 and L2-L3. The T12-L1 and L2-L3 syringes that will be used for group I will
contain 0.45 ml placebo (0.9% normal saline) per syringe. The syringe labeled L1-L2 will
contain 0.45 ml local anesthesia. On the other hand, the three syringes that will be used for
group III will contain 0.15 ml local anesthesia and 0.3 ml placebo. Consequently, all
patients will receive a total of 0.45 ml anesthesia and 0.9 ml placebo.
Data collection Demographic data such as age, weight and height will be collected.
Non-invasive mean arterial blood pressure and heart rate will be recorded preoperatively
(baseline), intraoperatively (incision of skin, dissection of hernia, traction over the sac
and closure of incision) and immediately postoperatively. During the operation, any
hemodynamic changes in excess of 15% from baseline values will result in a step-wise increase
or decrease of the sevoflurane concentration. Intra-operative sevoflurane concentration will
be recorded.
Postoperative pain assessment and analgesia As for pain assessment, the Face, Legs, Activity,
Cry, Consolability (FLACC) scale will be used to measure postoperative pain (0 indicating no
pain and 10 maximum possible pain).
Patients with pain score greater than 4 are given 1-2 mg/kg Tramadol hydrochloride (Tramal
drops, Laboratoire Grunenthal, Aachen, Germany) A 350 mg paracetamol suppository (Tylenol
CILAG SA, Schaffhouse, Switzerland) will be prescribed in pain score is less than 5.
During hospitalization trained nurses, blinded to the randomization, will collect the pain
scores. Following hospital discharge, pain scores will be assessed by parents through phone
calls made by the same nurses during the first postoperative day at predetermined time
intervals (0h, 6h, 12h, 24h).
