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Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery

ConditionObstetric Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEnte Ospedaliero Cantonale, Bellinzona

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

patients over 18 year of age

height over 160 cm

American Society Anesthesiologists physical status I and II

term singleton parturients

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fentanyl 1

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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

Treatment groups

63 Participants
are divided into 3 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Experimental 1Experimental treatment 1 intervention
Group C: Experimental 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient Controlled Analgesia morphine consumption

Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours

Time frame
Day 1 after cesarean section
2

obstetric quality of recovery score

obstetric quality of recovery score (ObsQoR-11)

Time frame
Day 1 after cesarean section

Secondary outcomes

1

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
2

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)
3

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)
4

intraoperative hypotension

intraoperative hypotension

Time frame
during the cesarean section

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ente Ospedaliero Cantonale, Bellinzona

Lead sponsor

Source ClinicalTrials.gov
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