NCT06355271

Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Ente Ospedaliero Cantonale, Bellinzona · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Obstetric Pain

Interventions

Type	Name	Description
PROCEDURE	Fentanyl 1	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
PROCEDURE	Fentanyl2	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
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 20 mcg of fentanyl

Timeline

• Start date: 2024-06-12
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-04-09
• Last updated: 2026-03-16

Locations

1 site across 1 country: Switzerland