Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery (MoFe)

Ente Ospedaliero Cantonale, Bellinzona

Status: Enrolling

Conditions: Obstetric Pain

Treatments: Procedure: Fentanyl2; Procedure: Fentanyl 1; Procedure: Fentanyl 3

Study type: Interventional

Funder types: Other

Identifiers

NCT06355271

2024-00019

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over 18 year of age
• height over 160 cm
• American Society Anesthesiologists physical status I and II
• term singleton parturients
• scheduled for elective cesarean delivery during spinal anesthesia at Ospedale Regionale Bellinzona Valli

Exclusion criteria

• patients with inability to consent
• patient refusal
• contraindication to spinal anesthesia (eg, hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis)
• emergency cesarean delivery
• preeclampsia/eclampsia
• allergy to drugs used in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 3 patient groups

Control

Active Comparator group

Description:

Spinal anesthesia with no fentanyl

Treatment:

Procedure: Fentanyl 1

Experimental 1

Experimental group

Description:

Spinal anesthesia with 10 mcg of fentanyl

Treatment:

Procedure: Fentanyl2

Experimental 2

Experimental group

Description:

Spinal anesthesia with 20 mcg of fentanyl

Treatment:

Procedure: Fentanyl 3