Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fentanyl 1, Fentanyl2, Fentanyl 3.
- Who it may be relevant to
- Registry conditions: Obstetric Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- 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
Primary outcome measures
- Patient Controlled Analgesia morphine consumption [Time frame: Day 1 after cesarean section]
- obstetric quality of recovery score [Time frame: Day 1 after cesarean section]
Secondary outcome measures (7)
- Visual Analogue Scale [Time frame: Day 1 after cesarean section]
- pruritus [Time frame: Day 1 after cesarean section (and day 0 for intraoperative pruritus)]
- 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 hypotension [Time frame: during the cesarean section]
- intraoperative opioids [Time frame: during the cesarean section]
- satisfaction rate [Time frame: Day 1 after cesarean section]
- intraoperative pain [Time frame: during the surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Ospedale Regionale di Bellinzona, San Giovanni — Bellinzona
Identifiers
NCT: NCT06355271 · 2024-00019