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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premixed group | Experimental | Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe. |
|
| Sequential group | Experimental | Patients will receive intrathecal fentanyl and bupivacaine in separate syringes. |
|
| Manual mixed group | Active Comparator | Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl and Bupivacaine | Drug | Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total analgesic consumption | The total amount of analgesic the patient will be given within 24 h after spinal anesthesia | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women undergoing cesarean section
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Fentanyl and Bupivacaine | Drug | Patients will receive intrathecal fentanyl and bupivacaine in separate syringes. |
|
| Fentanyl and Bupivacaine | Drug | Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe. |
|
| 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)] | 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 | 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). | Intraoperatively |
| Duration of sensory block | Duration of sensory block (The time till achieving T10 sensory level in addition to the maximum block height) will be noted and recorded. | Intraoperatively |
| Incidence of complications | Incidence of complications such as bradycardia, hypotension, nausea, Pruritus, shivering, respiratory depression, or any other complication will be recorded. | 24 hours postoperatively |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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