Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06274814 |
| Other study ID # |
AP23.501.038 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
National Cancer Institute, Egypt |
| Contact |
ahmed soliman |
| Phone |
00201286979695 |
| Email |
ams21787arif[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined
with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer
Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine
consumption in the first 24 h postoperative.
Description:
Patients will be randomly allocated into three groups based on a computerized randomization
table with specific ID for each patient (23 per group). Each patient will be prepared in
Preoperative Holding Area with sedation with midazolam 0.05mg/kg patients allotted to the RIB
group were positioned in the lateral decubitus position with the breast on the operating side
lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula
laterally. The RISS was performed after application of antiseptic solution. A high-frequency
using a 6-13 MHz linear ultrasound probe set to B mode (SonoSite M-turbo ultrasound machine)
was placed medial to the medial border of the scapula in the oblique sagittal plane. The
landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and
lung, were identified in the ultrasound. Under aseptic conditions, a 100-mm 21-gauge needle
was inserted at the level of T5-6 in the ultrasound view. A single dose of 20-mL 0.25%
bupivacaine was injected in the interfascial plane between the rhomboid major and intercostal
muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized
by ultrasonography. Thereafter, the ultrasound probe was moved caudally and laterally to
identify the tissue plane between the serratus anterior and external intercostal muscles for
the sub-serratus block at the T8-9 level. The needle was advanced from its previous position,
and an additional 20 mL of 0.25% bupivacaine was injected. All block procedures were
performed by the same anesthesiologist who had administered the RIB and RISS blocks in more
than 30 cases before this study. In control group (Group C), no block intervention was
performed.
After disinfection, using 30 mL of levobupivacaine 0.25% (10 mL between pectoralis minor
muscle and pectoralis major muscle, and 20 mL between the pectoralis major muscle and
serratus muscle). With the patient in supine position. (Group B) After shifting to the
operative area, all patients underwent conventional monitoring procedures including
electrocardiography, noninvasive monitoring of blood pressure, and peripheral oxygen
saturation measurements. Intravenous access was gained using a 22-gauge intravenous needle,
and isotonic saline was infused at a rate of 15 mL kg-1 h-1. Anesthetic management was in
accordance with a standard protocol. Anesthesia was induced with pre-oxygenation for 3 min
followed by intravenous injection of midazolam (0.05 mg/kg), fentanyl (0.1 µg/kg), propofol
(1-2 mg/kg), and atracurium (0.5 mg/kg). An endotracheal tube was used for positive-pressure
ventilation to maintain the end-tidal carbon dioxide level of 35-40 mmHg.
Anesthesia was maintained using 2% sevoflurane with 50% oxygen, fentanyl (0.1 µg kg-1 min-1),
and propofol (100 µg kg-1 min-1). Additionally, atracurium (0. 1 mg/kg) was administered
according to the surgical protocol. Surgery (Unilateral conservative mastectomy) was started.
The anesthetic dose was adjusted to maintain blood pressure within 20% of the baseline value.
An additional dose of intravenous fentanyl (0.1 µg kg-1 min-1) was injected as needed. If the
blood pressure decreased by > 20% from the baseline value, 250 mL of 0.9% (physiologic)
saline and ephedrine (0.1 mg/kg) were administered. If the heart rate decreased to less than
50 bpm, atropine (0.5 mg/kg) was administered. At the end of the surgery, the effect of
atracurium was reversed using neostigmine and atropine as needed. After the surgery, the
endotracheal tube was removed when the patient fulfills criteria of extubation. Then the
patient will be transferred to the PACU.
Data will be collected:
A. Intraoperative assessment: (readings will be taken just after induction and every 15 min
throughout surgery)
1. Heart rate intraoperative.
2. Mean arterial blood pressure intraoperative.
3. Analgesic consumption: recorded during intraoperative period to maintain maximum 20%
change of basal vital signs after exclusion of other causes. (Intraoperative fentanyl
consumption)
B. Postoperative:
1. Recovery time: the time taken to be fully awake and responding to commands.
2. Pain score: VAS score at 0, 3, 6, 9,24h post-operative.
3. Hemodynamic: pulse, B.P (systolic, diastolic, and mean blood pressure) at 0,3,6,9,24h
postoperative.
4. Side effects (nausea, vomiting, hematoma, hypotension, bradycardia).
5. Rescue analgesia plane will be given for VAS≥4 using non-steroidal anti-inflammatory
analgesic (ketorolac 30 mg) and VAS≥6 using opioid (3mg morphine). Time of the first
rescue analgesia together with frequency and total dose of the given drug through the 24
hours will be recorded.
6. Hospital discharge.
Primary outcome:
1. Total morphine consumption in first 24 hours post operative.
2. VAS score postoperative.
Secondary outcome:
1. Heart rate intraoperative.
2. Mean arterial blood pressure intraoperative.
3. Timing of first rescue analgesia.
4. Intraoperative fentanyl consumption.
5. Side effects (nausea, vomiting, hematoma, hypotension, bradycardia).
6. Body mass index (BMI).
