Clinical trial NCT06355271: Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstetric Pain
Keywords: Cesarean section
Fentanyl
Functional Recovery
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: Patient Controlled Analgesia morphine consumption
timeFrame: Day 1 after cesarean section
measure: obstetric quality of recovery score
timeFrame: Day 1 after cesarean section
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Day 1 after cesarean section
measure: pruritus
timeFrame: Day 1 after cesarean section (and day 0 for intraoperative pruritus)
measure: nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity
timeFrame: Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting)
measure: intraoperative hypotension
timeFrame: during the cesarean section
measure: intraoperative opioids
timeFrame: during the cesarean section
measure: satisfaction rate
timeFrame: Day 1 after cesarean section
measure: intraoperative pain
timeFrame: during the surgery
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale di Bellinzona, San Giovanni
Study officials:
References: