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Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery
In the study intervention group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 %, morphine sulfate 100 mcg and an added randomized dose of 10 or 20 mcg IT fentanyl. The spinal anesthetic will be administered with a 27 gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. The fentanyl doses will be prepared by an anesthesiologist who will not be involved in the study or the patient's treatment. For 24 hours following surgery, each patient would receive intravenous patient-controlled morphine analgesia. In the control group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 % and morphine sulfate 100 mcg. The spinal anesthetic will be administered with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. For 24 hours following surgery, each patient would receive intravenous patient- controlled morphine analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Spinal anesthesia with no fentanyl |
|
| Experimental 1 | Experimental | Spinal anesthesia with 10 mcg of fentanyl |
|
| Experimental 2 | Experimental | Spinal anesthesia with 20 mcg of fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl 1 | Procedure | Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and no fentanyl |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Controlled Analgesia morphine consumption | Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours | Day 1 after cesarean section |
| obstetric quality of recovery score | obstetric quality of recovery score (ObsQoR-11) | Day 1 after cesarean section |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | pain scores after surgery (Visual Analogue Scale -VAS- where 0 is the minimum value and 10 is the maximum value. The higher is the score the worse is pain control) at 4, 12 e 24 h. | Day 1 after cesarean section |
| pruritus |
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Inclusion Criteria:
Exclusion Criteria:
the study involves pregnant patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Dossi | Contact | 0918119341 | roberto.dossi@eoc.ch | |
| Alessandra Lauretta | Contact | 0918118182 | alessandra.lauretta@eoc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Regionale di Bellinzona, San Giovanni | Recruiting | Bellinzona | Switzerland |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C030592 | 3-methylfentanyl |
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Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups
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Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program. The identification code will be present on the data collection form (where the patient's name, surname or date of birth will not appear to ensure blinding of the study).
Personnel not directly involved with patient care, present during the randomization process, will sterilely prepare anesthesia solution while maintaining a total volume of 3,1 ml. This will allow blinding of patients, care providers and data collectors. The procedure will take place as a common clinical practice in our center. When performing spinal anesthesia, sterility is of fundamental importance, so it will not be possible to have the syringe used tagged. In the kit all materials will be sterile
| Fentanyl2 | Procedure | Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 10 mcg of of fentanyl |
|
| Fentanyl 3 | Procedure | Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 20 mcg of fentanyl |
|
Intraoperative and postoperative pruritus (rating 0-10 The higher is the score the worse is pruritus)
| Day 1 after cesarean section (and day 0 for intraoperative pruritus) |
| nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity | intraoperative and postoperative nausea and vomiting | Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting) |
| intraoperative hypotension | intraoperative hypotension | during the cesarean section |
| intraoperative opioids | intraoperative opioids in morphine equivalents | during the cesarean section |
| satisfaction rate | satisfaction rate (0-100, where 0 is the minimum value and 100 is the maximum value. The higher is the score the better is the satisfaction rate) | Day 1 after cesarean section |
| intraoperative pain | intraoperative pain Visual Analogue Scale (Visual Analogue Scale -VAS- where 0 is the minimum value and 10 is the maximum value. The higher is the score the worse is pain control) | during the surgery |