Ospedale Regionale di Bellinzona, San Giovanni
Bellinzona, Switzerland
Location status: Recruiting
NCT Number: NCT06355271
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
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Bellinzona, Switzerland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: Day 1 after cesarean section
Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours
Time frame: Day 1 after cesarean section
obstetric quality of recovery score (ObsQoR-11)
Time frame: Day 1 after cesarean section
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.
Time frame: Day 1 after cesarean section (and day 0 for intraoperative pruritus)
Intraoperative and postoperative pruritus (rating 0-10 The higher is the score the worse is pruritus)
Time frame: Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting)
intraoperative and postoperative nausea and vomiting
Time frame: during the cesarean section
intraoperative hypotension
Time frame: during the cesarean section
intraoperative opioids in morphine equivalents
Time frame: Day 1 after cesarean section
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)
Time frame: during the surgery
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)
Contact information is provided by the study sponsor or research team.
Alessandra Lauretta
CONTACT
Roberto Dossi
CONTACT
Ente Ospedaliero Cantonale, Bellinzona
Other
Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery Adding Different Doses of Intrathecal Fentanyl to Spinal Anesthesia With Bupivacaine and Intrathecal Morphine. A Single Center, Randomized, Multiple Blinded, Controlled Trial
Acronym: MoFe
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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