Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06419556 |
| Other study ID # |
MS-425-2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 5, 2023 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Cairo University |
| Contact |
Nagy malak |
| Phone |
01552480258 |
| Email |
nagymalak[@]kasralainy.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to investigate the analgesic efficacy of Intermediate Cervical Plexus Block
combined with GA using two bupivacaine concentrations in patients undergoing neck surgeries
(total thyroidectomy or total laryngectomy)
Description:
This randomized comparative study was conducted in Cairo University hospitals after the
approval of the institutional research and ethics committee. Informed consent was obtained
from all participants. The Consolidated Standards of Reporting Trials (CONSORT) Guidelines
were followed.
The patients were randomly allocated into two groups (H & L) using computer generated random
numbers that were concealed in opaque envelopes. Group H received 20 ml 0.25 % bupivacaine
and Group L received 20 ml 0.125% bupivacaine bilaterally.
- On arrival to the operating room, an 18G cannula was inserted with the infusion of 500
ml Ringer solution. Controloc 40 mg, ondansetron 8 mg, and dexamethasone 8 mg were
administered as premedication. The diaphragmatic motion was assessed by a 3.5 MHz
curvilinear transducer, siemens ACUSON X300 ultrasound. Each hemidiaphragm was first
visualized by B-mode then M-mode was used to evaluate diaphragmatic excursion. For the
right hemidiaphragm, the transducer was placed perpendicularly over the right subcostal
margin in the anterior axillary line, the prob was then directed cephalad and dorsally
to reach the posterior one-third of the diaphragm. Diaphragmatic excursions were
measured and recorded in millimeters using the liver as an acoustic window during quiet
breathing. The left hemidiaphragm was assessed in the same way using the spleen as an
acoustic window.
- All patients connected to an electrocardiograph (ECG), pulse oximeter, and non-invasive
blood pressure (NIBP), and baseline values of HR and MAP were measured and recorded.
Additional monitoring in the form of a capnogram, invasive blood pressure (IBP) through
a radial artery cannula, peripheral nerve stimulator (PNS), Bispectral index (BIS), and
urine output were connected after induction of GA. Anesthesia was induced by intravenous
fentanyl 2µg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg. When the TOF count showed
the disappearance of T1 (0/4), an appropriate-size endotracheal tube was inserted and
secured. Under complete aseptic conditions, ultrasound guided bilateral ICPB was
performed by a single staff anesthetist who is skilled in carrying out regional
anesthesia.
- ICPB technique: The patient's head was rested on a pillow and turned to the opposite
side. A linear probe with higher frequencies was placed transversely over the midpoint
of the SCM muscle. The carotid artery was identified and traced upwards to its
bifurcation. the probe was then moved laterally to identify the tapering posterolateral
end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced
underneath the investing fascia of SCM muscle and above the interscalene groove until
the "pop" on piercing the investing fascia was felt. The patient was then randomly
allocated into two groups (H & L) using computer generated random numbers that were
concealed in opaque envelopes. Group H received 20 ml 0.25 % bupivacaine and Group L
received 20 ml 0.125% bupivacaine. The technique was repeated on the opposite side.
- During the intraoperative period, anesthesia was maintained with isoflurane 1.2-1.5 vol%
to keep BIS value at 40-60 and atracurium 0.1mg/kg guided by PNS. Additional doses of
fentanyl 0.05 µg/kg were administered when HR or MAP increased > 20% of the baseline
values. MAP and HR were measured after the skin incision, and then every 30 minutes till
the end of surgery. The failed block was considered when ≥ four additional doses of
fentanyl were required to manage the increased MAP or HR after skin incision. At the end
of the surgery, one gram of paracetamol plus 30 mg of ketorolac were administered.
- During the postoperative period, regular analgesia in the form of intravenous
paracetamol one gram/8hr was prescribed. Pain severity was assessed by using the visual
analog scale (VAS) (0= no pain and 100mm= worst pain) at 2, 4, 6, 8, 12, 18, and 24 hr
postoperatively. Rescue analgesia in the form of intravenous morphine 0.05 mg/kg was
given on the patient's complaint or when VAS ≥ 40 mm and repeated every 15-20 minutes
until VAS < 40 mm with a maximum morphine dose of 40 mg per 24 hours. The duration of
analgesia was calculated as the time elapsed from the end of the ICPB block procedure
till VAS ≥ 40mm. The total postoperative morphine consumption over 24 hours was
calculated. The measurement of diaphragmatic excursions was repeated as mentioned above,
hemi-diaphragmatic paresis was divided into three grades, depending on the percentage of
diaphragm movement compared with baseline to be: none (> 75%), partial paresis (25-75%),
and complete paresis (< 25%)
