Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06168903 |
| Other study ID # |
N-402-2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 5, 2023 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Cairo University |
| Contact |
Nagy malak |
| Phone |
01552480258 |
| Email |
nagymalak12345[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to compare a single shot of bilateral ultrasound-guided EOI block and ESPB in
terms of intraoperative opioid consumption, postoperative pain control in the first 24 hours,
and the need for rescue analgesics.
Description:
The study is randomized, controlled, double blinded trial and conducted in Cairo university
hospital after approval of departmental and institutional research ethics committee. Written
informed consent will be obtained from all participants. Randomization will be achieved using
a computer-generated sequence. Concealment will be achieved using opaque envelopes.
On arrival of the patients to operating room, patients will be secured with 20 gauge
intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure
(NIBP), and pulse oximetry (SpO2). Before receiving general anesthesia, patients will be
randomly assigned into one of the two study groups; EOI block Group and ESPB Group.
Induction of general anesthesia will be induced with patients in ramped position and after
adequate preoxygenation using 1 µg/kg fentanyl (based on lean body weight), 2 mg/kg propofol
(based on total body weight), and 0.5 mg/kg atracurium (based on the ideal body weight), in
addition to 8mg IV dexamethasone for prevention of postoperative nausea & vomiting.
Endotracheal intubation will be established. Anesthesia will be maintained by 1.2% MAC of
isoflurane with oxygen (50%) in air and 0.1 mg/kg of atracurium will be administered every 20
minutes as maintenance anesthetic drugs. Volume-controlled ventilation will be maintained
with a tidal volume of 6 mL/kg of ideal body weight and the respiratory rate will be adapted
to maintain ET CO2 between 30 and 40 mmHg, and a 10 cmH2O positive end-expiratory pressure
(PEEP) will be applied in all patients. Monitoring through ECG, NIBP, pulse oximetry and
capnography (ETCO2) continued throughout the surgeries.
US (Siemens ACUSON X300 Ultrasound System) guided blocks will be administered immediately
after the induction of anesthesia and prior to surgical incision by consultant
anesthesiologists who had experience in regional anesthesia and were familiar with the EOI
and ESPB blocks.
EOI block Group (n=25): this group will receive bilateral ultrasound-guided external oblique
intercostal block.
The technique of ultrasound-guided EOI block will be performed with the patient in supine
position. A linear ultrasound probe (4-12MHz) will be placed paramedian sagittal orientation
between the midclavicular and anterior axillary lines at the level of sixth rib, visualizing
the external oblique and intercostal muscles. Local anesthetics inject the under the external
oblique muscle.
A 22-gauge needle will be advanced in-plane superomedial-to-inferolateral direction, into the
fascial plane between the external oblique and intercostal muscles at the caudal end of the
sixth rib and between the sixth and seventh ribs. The location of the needle tip will be
confirmed by hydrodissection of inter-fascial planes by 3 ml of normal saline. After negative
aspiration, a total of 20 mL bupivacaine 0.25% will be injected in the fascial plane
incrementally, aspirating every 5 ml and the block will be repeated on the other side.
ESPB Group (n=25): this group will receive bilateral ultrasound-guided erector spinae plane
block The technique of ultrasound-guided ESPB will be performed with the patient in lateral
position. A curvilinear ultrasound probe (5-7 MHz) will be placed transversely to identify
tip of T9 transverse process 2.5-3 cm from midline then it will be rotated longitudinally to
get a parasagittal view visualizing the transverse process as a hyperechoic curvilinear
structure with prominent finger-like acoustic shadowing beneath (the trident sign), with
lamina (sawtooth pattern), spinous process, and costochondral junction medially and
laterally. The erector spinae muscles are identified superficial to the tip of the T9
transverse process. A 22-gauge needle will be advanced in-plane craniocaudally into the
fascial plane deep to erector spinae muscle. The location of the needle tip will be confirmed
by hydrodissection of erector spinae muscle from tip of transverse process by 3 ml of normal
saline. After negative aspiration, a total of 20 mL bupivacaine 0.25% will be injected under
the fascial plane incrementally, aspirating every 5 ml and the block will be repeated on the
other side.
To achieve double blinding, patients will receive the block with 40 mL bupivacaine (0.25%) by
the anesthetist. Another doctor not involved in the block procedure will evaluate the
patients intraoperative and postoperative.
Intraoperative inadequate analgesia, indicated by increase of HR or MAP more than 20% above
preinduction baseline values, will be managed using incremental 50 microgram doses of
fentanyl. Intraoperative fentanyl consumption will be calculated. All patients will receive
10 minutes before the end of surgery 1 mg granisetron or 4 mg ondansetron IV for antiemetic
prophylaxis and ketorolac 30mg IV and paracetamol 1g for postoperative analgesia. At the end
of surgery, muscle relaxant will be reversed using neostigmine 0.05 mg/kg and atropine 0.02
mg/kg. Awake extubation will be established after adequate reversal of neuromuscular block.
Patients will be transported to PACU and placed in the semi-sitting position, and oxygen will
be given via a nonrebreathing facemask with a reservoir bag. Postoperative pain will be
assessed using VAS (where 0 corresponds to no pain and 100 mm to the worst pain) at 2, 4, 6,
12, 18, and 24 hours postoperatively.
Postoperatively, all patients will receive 1 g paracetamol every 6 h, 30 mg ketorolac every
12 h.
IV morphine titration will be carried out at patient wake-up to achieve pain control (VAS ≤
30mm) by an attending anesthesiologist blinded to group allocation. Patients with a VAS score
of ≥ 40mm and patients who will request rescue analgesia will be treated with IV morphine in
2 mg increments every 5 minutes with no upper limit for the total administered dose and total
morphine consumption will be recorded. If the patient appeared sedated (Ramsay sedation scale
> 2), and/or severe morphine-related side effects are encountered including respiratory
depression (Spo2 < 95% and/or respiratory rate < 12 breaths/min), allergic reaction,
hypotension, or severe pruritus, morphine titration will be stopped and the patient will be
excluded from the study.
