Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery

Last updated: September 2, 2024
Sponsor: Ente Ospedaliero Cantonale, Bellinzona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Pain

Treatment

Fentanyl 1

Fentanyl 3

Fentanyl2

Clinical Study ID

NCT06355271
2024-00019
  • Ages > 18
  • Female

Study 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

Eligibility Criteria

Inclusion

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 OspedaleRegionale Bellinzona Valli

Exclusion

Exclusion Criteria:

  • patients with inability to consent

  • patient refusal

  • contraindication to spinal anesthesia (eg, hemodynamic instability, infection at thesurgery site, and neurologic defects such as transverse myelitis)

  • emergency cesarean delivery

  • preeclampsia/eclampsia

  • allergy to drugs used in the protocol

Study Design

Total Participants: 63
Treatment Group(s): 3
Primary Treatment: Fentanyl 1
Phase:
Study Start date:
June 12, 2024
Estimated Completion Date:
September 01, 2025

Study 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.

Connect with a study center

  • Ospedale Regionale di Bellinzona, San Giovanni

    Bellinzona,
    Switzerland

    Site Not Available

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