This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.
Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.
Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe.
Tanta University
Tanta, El-Gharbia, Egypt
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to first dose of pethidine administrated).
Time frame: 24 hours postoperatively
Total analgesic consumption
The total amount of analgesic the patient will be given within 24 h after spinal anesthesia
Time frame: 24 hours postoperatively
Degree of pain
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.
Time frame: 24 hours postoperatively
Onset of motor block
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 \[0: No motor block, 1: Unable to raise an extended leg (able to flex the knee), 2: Unable to flex the knee (able to move the foot only), 3: Unable to flex the ankle (unable to move the foot or knee)\]
Time frame: Intraoperatively
Duration of motor block
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
Time frame: Intraoperatively
Onset of sensory block
Onset of sensory block (time elapsed from the end of spinal injection to absence of pinprick sensation at T10 dermatome).
Time frame: Intraoperatively
Duration of sensory block
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Duration of sensory block (The time till achieving T10 sensory level in addition to the maximum block height) will be noted and recorded.
Time frame: Intraoperatively
Incidence of complications
Incidence of complications such as bradycardia, hypotension, nausea, Pruritus, shivering, respiratory depression, or any other complication will be recorded.
Time frame: 24 hours postoperatively