Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05617482 |
| Other study ID # |
35633/8/22 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
November 2022 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To compare between Ultrasound guided ilioinguinal, iliohypogastric nerve blocks, TAP block
and Quadratus lumborum block in patients scheduled for lower segment ceserian sections.
Description:
One hundred and fifty patients belonging to the American Society of Anesthesiologists
physical status 1 and 2, aged between 18 and 45 years and will be scheduled for emergency or
elective lower segment cesarean section (LSCS) under general anesthesia will be selected
between (December 2022 to March 2023, written informed consent will be obtained from all
participants.
Inclusion criteria: ASA 1& 2, Age between 18 and 45 years , scheduled for emergency or
elective CS under spinal anesthesia; While exclusion criteria:pregnant women who will refuse
to participate, known allergy to local anesthetic, infection at the block site.
Patients who will not willing to give consent, known allergy to local anesthetic or infection
at the block site will be excluded from the study.
All patients will receive standard premedication according to institute protocol with
ranitidine and metoclopramide intravenously immediately before shifting the patient into the
operating room for emergency LSCS or 2 h before by oral route in case of elective LSCS.
Inside the operating room under all aseptic precautions, spinal anesthesia will be
administered using 1.8 ml of 0.5% of heavy bupivacaine without any adjuvant in L3-L4 space
using Quincke's needle by the attending anesthesiologist. The case will be managed by the
same person without any narcotics intraoperatively. At the end of the procedure just before
the skin closure, 1 g of injection paracetamol will be administered intravenously over a
period of 20 min as a part of multimodal analgesia. At the end of the surgery, patients will
be randomized into ILIH (50 patients) , TAP block group (35 patients) or quadratus lumborum
group (50 patients) by choosing a closed envelope, which will contain a standard data
collection sheet and an allocation card. All the blocks were performed by the principle
investigator under aseptic precautions and ultrasound guidance using high frequency linear
probe resonating at 12 MHz in the multi-beam mode. In TAP block group, the probe will be
placed perpendicular to the mid-axillary line between the iliac crest and the subcostal
margin and the three abdominal muscle layers will be identified, and the transverses
abdominis plane will be located between the internal oblique and the transverse abdominis
muscle. The TAP will be approached through in-plane technique using a 23-gauge Quincke spinal
needle attached to a 20 ml syringe of 0.25% bupivacaine will be injected and the drug spread
in the plane will be observed. The same procedure will be repeated on the other side of the
abdomen.
In ILIH group, the probe will be placed medial to the lateral one-third of the line joining
the umbilicus and the anterior superior iliac spine (ASIS), with part of the probe sitting on
the ASIS. The ASIS, iliacus muscle, internal oblique, transverses abdominis, and the ILIH
nerves between them will be identified. After appreciating the sonoanatomy, the ILIH nerve
will be approached with the 23-gauge Quincke spinal needle through in-plane technique and 10
ml of 0.25% bupivacaine will be injected all around and the drug spread will be appreciated.
The same procedure will be repeated on the other side.
For the QLB, the transducer will be placed at the level of the anterosuperior iliac spine and
will move cranially until the 3 abdominal wall muscles will be clearly identified. The
external oblique muscle will be followed posterolaterally until its posterior border was
visualized (hook sign), leaving underneath the internal oblique muscle, like a roof over the
quadratus lumborum muscle. The probe will be tilted down to identify a bright hyperechoic
line that corresponded with the middle layer of he thoracolumbar fascia. The needle (21
gauge) will be inserted in plane from anterolateral to posteromedial. The optimal point of
injection for the QL block will be determined over the lumbar interfacial triangle using
hydrodissection.
At the end of the procedure, patients will be shifted to the postanesthesia recovery room and
later to the postoperative ward after establishing the block.
The sensory assessment following the TAP, ILIH, and QLB block will be done after confirming
the spinal regression below the level of L2 dermatome. The block will be considered
"Successful" when the patient will not be able to perceive the cold sensation at L1 dermatome
(inguinal region) on both sides. The block will be considered "Partial" when patient
perceives cold sensation on any one of the side.
The block will be considered "Failure" when the patient perceives cold sensation on both
sides at L1 dermatome. Patients suffering partial and failed block will be excluded from the
study for further analysis but will receive standard postoperative analgesics as any other
patients. In the postoperative ward, whenever, the patient complained of pain, nurse
in-charge will note the numerical rating scale (NRS) score, and will administered a single
dose of injection diclofenac sodium of 50 mg as slow intravenous infusion over a period of 15
min and will note the time as time of first analgesia. Subsequently, whenever patient
complain of pain, injection tramadol 50 mg will be given intravenously for the remaining 24
h.
A blinded observer who will not be aware of the group allocation will visit the patient at 2,
4, 6, 10, 12, and 24 h postoperative intervals and analyz the study parameters and record in
the common standard data nalogue scale for pain (ranging from 0 to 10 with 0 no pain, 10
being severe pain, and the patients will be asked to mark the pain score on the scale) during
rest as well as on movement (turning lateral to any one side). Duration of analgesia will be
taken as time interval between the block time and the time of first analgesia.
The 24 h requirement of rescue analgesics injection diclofenac sodium and injection tramadol
and complications such as nausea, vomiting, transient femoral nerve palsy, any signs, and
symptoms of bowel perforation will be noted.
