Cesarean Section
Conditions
Keywords
transversus abdominis plane block, morphine, fentanyl, spinal anesthesia, cesarean section, postoperative analgesia
Brief summary
This noninferiority study aims to determine whether transversus abdominis plane (TAP) block with intrathecal fentanyl could provide a noninferior analgesia compared with intrathecal morphine after cesarean delivery under spinal anesthesia.
Detailed description
Healthy mothers scheduled to undergo elective cesarean delivery under spinal anesthesia will be randomly allocated to receive either TAP block plus intrathecal fentanyl (Group TF) or intrathecal morphine (Group M). Primary outcome is pain score with movement at postoperative 24 hours.
Interventions
DRUGfentanyl
Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.
DRUGmorphine
Morphine 75 mcg will be injected intrathecally during spinal anesthesia.
PROCEDURETransversus abdominis plane block
Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.
PROCEDURESham block
Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult full-term parturients scheduled to undergo elective cesarean delivery under spinal anesthesia
Exclusion criteria
* Contraindication to spinal anesthesia * Any chronic pain unrelated pregnancy * current opioid medication use * BMI more than 40 kg m-2 * History of drug allergy or hypersensitivity to fentanyl, morphine, ropivacaine, acetaminophen, NSAIDs, bupivacaine, ramosetron, ondansetron, nalbuphine, Naloxone, metoclopramide * infection of abdominal wall * Pregnancy-induced hypertension * known cardiovascular disease * Known fetal anomaly * Any sign of onset of labor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score with movement at 24 hours after delivery | at 24 hours after delivery | Pain score with movement at 24hr after delivery, using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score at rest | at 6, 12, 18, 24, 48 hours after delivery | Pain score at rest using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable) |
| Pain score with movement | at 6, 12, 18, 48 hours after delivery | Pain score with movement using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable) |
| time to first opioid request | during hospital stay, an average of 3 days | time to first intravenous fentanyl administration from delivery |
| number of patients requiring rescue analgesics | During the first 48 hour-period after delivery | number of patients requiring rescue analgesics |
| Incidence of nausea | During the first 48 hour-period after delivery | Proportion of patients who experienced nausea |
| Incidence of vomiting | During the first 48 hour-period after delivery | Proportion of patients who experienced vomiting |
| Incidence of pruritus | During the first 48 hour-period after delivery | Proportion of patients who experienced pruritus |
| Incidence of sedation | During the first 48 hour-period after delivery | Proportion of patients who experienced sedation |
| Intravenous fentanyl consumption | at 6, 12, 18, 24, 48 hours after delivery | cumulative fentanyl consumption via intravenous patient-controlled analgesia |
| Nausea severity | During the first 48 hour-period after delivery | Nausea severity using 4-point scale with 0=none, 1=mild, 2=moderate, or 3=severe |
| Pruritus severity | During the first 48 hour-period after delivery | Pruritus severity using 4-point scale with 0=none, 1=mild, 2=moderate, or 3=severe |
| Patient satisfaction for overall postoperative managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied) | During the first 48 hour-period after delivery | Patient satisfaction score for overall postoperative pain managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied) |
| Hospital length of stay | From admission to hospital discharge, an average of 3 days | Hospital length of stay (day) |
| Apgar Score | at 1 minute, at 5 minutes | Apgar Score of fetus |
| Umbilical arterial pH | immediately after delivery | Umbilical arterial pH |
| Umbilical arterial PO2 | immediately after delivery | Umbilical arterial PO2 |
| Umbilical arterial PCO2 | immediately after delivery | Umbilical arterial PCO2 |
| Incidence of respiratory depression | During the first 48 hour-period after delivery | Proportion of patients who experienced respiratory depression |
Countries
South Korea
Outcome results
None listed