An interventional study of Fentanyl 1 and Fentanyl2 in Obstetric Pain, sponsored by Ente Ospedaliero Cantonale, Bellinzona. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Ente Ospedaliero Cantonale, Bellinzona · Not applicable, Interventional, and Treatment
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.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's planned enrollment of 63 is below the median of 100 across 325 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Ente Ospedaliero Cantonale, Bellinzona is the lead sponsor of 37 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Spinal anesthesia with no fentanyl
Procedure: Fentanyl 1
Spinal anesthesia with 10 mcg of fentanyl
Procedure: Fentanyl2
Spinal anesthesia with 20 mcg of fentanyl
Procedure: Fentanyl 3
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
Patient Controlled Analgesia morphine consumption
Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours
Time frame: Day 1 after cesarean section
obstetric quality of recovery score
obstetric quality of recovery score (ObsQoR-11)
Time frame: Day 1 after cesarean section
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.
Time frame: Day 1 after cesarean section
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 pruritus)
nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity
intraoperative and postoperative nausea and vomiting
Time frame: Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting)
intraoperative hypotension
intraoperative hypotension
Time frame: during the cesarean section
intraoperative opioids
intraoperative opioids in morphine equivalents
Time frame: 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)
Time frame: 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)
Time frame: during the surgery
Plan to share: No
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Ente Ospedaliero Cantonale, Bellinzona