Cesarean Section Complications
Conditions
Brief summary
This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia.
Interventions
PROCEDUREErector Spinae Plane Block
A nerve block that injects local anesthetic in the Erector Spinae Plane
DRUGIntrathecal morphine
Intrathecal morphine at the time of spinal anesthesia
Sponsors
Thammasat University
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing scheduled Cesarean delivery
Exclusion criteria
* Patients with an ASA score greater than 3 * Allergies to study medications * Contraindications to neuraxial analgesia * Patients with chronic pain * Patients unable to communicate in the study language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour area under the curve pain scores | First 24 hour | It will be measured at 3 6 12 18 and 24 hours after the end of the cesarean delivery. This pain will be assessed by asking the patient to go from lying to sitting (or use incentive spirometry) and rated using a linear 10 cm visual analogue scale (VAS). The 24 hour pain VAS area under the curve (AUC) will be calculated using the trapezoid rule. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of quality of recovery after cesarean delivery | First 24 hours | At 24 hours the ObsQoR11, a validated instrument to measure the quality of recovery after cesarean delivery, will be administered to the patient |
| Nausea and vomiting | First 24 hours | The incidence of nausea and vomiting will be rated on a 10 cm VAS |
| Analgesic usage | First 24 hours | The cumulative use of opioids, expressed as morphine equivalents will be recorded at 24 hours. |
| Pruritus | First 24 hours | The incidence of pruritus will be rated on a 10 cm VAS |
| Incidente of persistent surgical pain | Three months | Patients will be contacted by telephone 3 months after the cesarean to assess the presence of chronic pain. This will be done using a modification of the brief pain inventory |
Countries
Canada
Contacts
Primary ContactAlbert Moore, MD
Outcome results
None listed