Obstetric Pain
Conditions
Keywords
Cesarean section, Fentanyl, Functional Recovery
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.
Interventions
PROCEDUREFentanyl 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
PROCEDUREFentanyl2
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
PROCEDUREFentanyl 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
Sponsors
Ente Ospedaliero Cantonale, Bellinzona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program. The identification code will be present on the data collection form (where the patient's name, surname or date of birth will not appear to ensure blinding of the study). Personnel not directly involved with patient care, present during the randomization process, will sterilely prepare anesthesia solution while maintaining a total volume of 3,1 ml. This will allow blinding of patients, care providers and data collectors. The procedure will take place as a common clinical practice in our center. When performing spinal anesthesia, sterility is of fundamental importance, so it will not be possible to have the syringe used tagged. In the kit all materials will be sterile
Intervention model description
Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Controlled Analgesia morphine consumption | Day 1 after cesarean section | Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours |
| obstetric quality of recovery score | Day 1 after cesarean section | obstetric quality of recovery score (ObsQoR-11) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pruritus | 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) |
| nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity | Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting) | intraoperative and postoperative nausea and vomiting |
| intraoperative hypotension | during the cesarean section | intraoperative hypotension |
| intraoperative opioids | during the cesarean section | intraoperative opioids in morphine equivalents |
| intraoperative pain | 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) |
| satisfaction rate | 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) |
| Visual Analogue Scale | 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. |
Countries
Switzerland
Contacts
CONTACTRoberto Dossi
CONTACTAlessandra Lauretta
Outcome results
None listed