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NCT Number: NCT06355271

Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Regionale di Bellinzona, San Giovanni

Bellinzona, Switzerland

Location status: Recruiting

Location contact

Roberto Dossi, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl 1

Procedure

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

Fentanyl2

Procedure

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

Fentanyl 3

Procedure

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

Primary outcomes

  1. Patient Controlled Analgesia morphine consumption

    Time frame: Day 1 after cesarean section

    Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours

  2. obstetric quality of recovery score

    Time frame: Day 1 after cesarean section

    obstetric quality of recovery score (ObsQoR-11)

Secondary outcomes

  1. Visual Analogue Scale

    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.

  2. pruritus

    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)

  3. nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity

    Time frame: Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting)

    intraoperative and postoperative nausea and vomiting

  4. intraoperative hypotension

    Time frame: during the cesarean section

    intraoperative hypotension

  5. intraoperative opioids

    Time frame: during the cesarean section

    intraoperative opioids in morphine equivalents

  6. satisfaction rate

    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)

  7. intraoperative pain

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Lauretta

CONTACT

[email protected]

0918118182

Roberto Dossi

CONTACT

[email protected]

0918119341

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2024
Registry last updated
Mar 16, 2026

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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