Analgesia, Analgesia, Obstetrical, Analgesics, Non-Narcotic, Analgesics, Opioid, Anesthesia, Obstetrical, Anesthesia, Spinal, Dexmedetomidine
Conditions
Brief summary
The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section. The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.
Detailed description
52 patients will be recruted for this study, and will be randomized in two equal groups. All the interventions carried out will be standardized. Medical care for patients will be the same as usual care, except for administration of dexmedetomidine or intrathecal narcotics. In the test group, bupivacaine (12 mg, 1.6 ml) will be injected with 3 mcg of dexemedetomidine. In the second group, bupivacaine (12 mg, 1.6 ml) will be injected with 100 mcg of morphine and 15 mcg of fentanyl with 0.25 ml of normal saline, which corresponds to the standard treatment. The patients will receive standard analgesia, described in the protocol, post-operatively and will also have access to anti-nausea and anti-pruritics. The patient will then be seen the day after surgery to collect her validated self-assessment scales for pain, nausea and vomiting, pruritus, chills and complete her QoR15 questionnaire. This will be collected to establish preliminary data for a second study of non-inferiority for analgesia and gradation of side effects.
Interventions
DRUGDexmedetomidine 0.004 MG/ML [Precedex]
Injection of 3 mcg of dexmedetomidine and 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.
DRUGOpioids
Injection of 100 mcg of morphine, 15 mcg of fentanyl and 0.25 ml of normal salin (sterile) with 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Pilot study for a phase 3 study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient will receive an elective c-section under spinal anesthesia * Gestational age \> 37 weeks
Exclusion criteria
* ASA score ≥ 3 * Allergy or contraindication to receiving opioids (morphine or fentanyl) * Allergy or contraindication to receiving anti-inflammatory drugs (ketorolac, Naprosyn) * Allergy or contraindication to receiving acetaminophen * Height \<152 cm or\> 183 cm * Weight \<50 or\> 110 kg * Contraindication to spinal anesthesia * Conversion to general anesthesia * Combined spinal-epidural anesthesia * Inability to give informed consent, either secondary to a mental or physical disability or a significant language barrier (Inability to understand English or French) * Need for transfusion or other major complication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 3 study feasability | 3 months | The primary outcome will be to evaluate the phase 3 study feasability through recrutement rates and time needed to recrut a total of 52 patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioids consumption | 24 hours post-operatively | Total morphine equivalent consumed by the patient |
| Pruritus | 2, 6, 12 and 24 hours after surgery | Self-assessed validated numerical pruritus scale (NPS). Scale between 0 and 10, 10 being the worst symptoms the patient can imagine. |
| Nausea | 2, 6, 12 and 24 hours after surgery | Absence or presence of nausea / vomiting at 2, 6, 12 and 24 hours after surgery |
| Pain level | 2, 6, 12 and 24 hours after surgery | Self-assessed validated numerical pain scale (NPS).Scale between 0 and 10, 10 being the worst symptoms the patient can imagine. |
| Quality of recovery and patient's satisfaction | 24 hours after surgery | Satisfaction according to the QoR15 questionnaire. Questionnaire containing 15 question to evaluate the quality of recovery in patients after a surgery. |
Countries
Canada
Outcome results
None listed