Premixed, Sequential, Manually Mixed, Intrathecal, Fentanyl, Bupivacaine, Cesarean Section
Conditions
Brief summary
This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section.
Detailed description
Cesarean section (CS) is a lifesaving procedure when there is both maternal and fetal problems. The rate of CS increases dramatically from time to time. Regional anesthesia techniques are highly preferred for CS compared to general anesthesia. Coadministration of intrathecal opioids and local anesthetics (LAs) have been found to produce a potent intra and postoperative analgesic synergism without further depression of efferent sympathetic activity, hence results in less adverse hemodynamic effects, even with sub-therapeutic doses of LAs. Fentanyl has been considered the intrathecal LAs adjuvant of choice owing to its potency, fast onset and short duration of action, and lower incidence of respiratory depression.
Interventions
Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 40 years. * Height between 150 to175 cm. * Body mass index (BMI) between 18.5 and 30 kg/m2. * American Society of Anesthesiology (ASA) physical status II. * Scheduled for cesarean section under spinal anesthesia.
Exclusion criteria
* Pre-operation hypotension and bradycardia. * Preeclampsia. * Multiple pregnancy and macrosomia. * Complete or partial failed spinal. * Patients with skin infections at the site of injection. * Patients with coagulation disorders. * Patients with spinal deformities. * Patients having regional nerve block other than spinal anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the 1st rescue analgesia | 24 hours postoperatively | Time to the first request for the rescue analgesia (time from end of surgery to first dose of pethidine administrated). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 24 hours postoperatively | The degree of pain will be assessed using the numerical rating scale (NRS). NRS (0 represents no pain while 10 represents the worst pain imaginable). NRS will be assessed at 0, 2, 4, 6, 8, 12, 18, and 24h postoperatively. |
| Onset of motor block | Intraoperatively | onset of motor block (defined as the time from giving spinal anesthesia until a modified Bromage score of 3 was reached). The modified Bromage scale \[0: No motor block, 1: Unable to raise an extended leg (able to flex the knee), 2: Unable to flex the knee (able to move the foot only), 3: Unable to flex the ankle (unable to move the foot or knee)\] |
| Duration of motor block | Intraoperatively | Duration of motor block (defined as the time from the onset of motor blockade until complete recovery, indicated by a Bromage score of 0) will be recorded |
| Total analgesic consumption | 24 hours postoperatively | The total amount of analgesic the patient will be given within 24 h after spinal anesthesia |
| Duration of sensory block | Intraoperatively | Duration of sensory block (The time till achieving T10 sensory level in addition to the maximum block height) will be noted and recorded. |
| Incidence of complications | 24 hours postoperatively | Incidence of complications such as bradycardia, hypotension, nausea, Pruritus, shivering, respiratory depression, or any other complication will be recorded. |
| Onset of sensory block | Intraoperatively | Onset of sensory block (time elapsed from the end of spinal injection to absence of pinprick sensation at T10 dermatome). |
Countries
Egypt
Outcome results
None listed