Cesarean Section, Multimodal Analgesia
Conditions
Keywords
dexmedetomidine, transversus abdominis plane block
Brief summary
To evaluate the effect of dexmedetomidine as an adjuvant of ropivacaine in the TAP block on cesarean section parturients under multimodal analgesia, optimize the multimodal analgesia program for cesarean section, and guide perioperative analgesia managemen。This is a single center, double-blind, randomized clinical trial.
Interventions
DRUGDexmedetomidine
each side dexmedetomidine 0.5ug/kg TAP block
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1\) 37-42 weeks of gestation 2\) Plan cesarean section 3\) Receiving patient controlled intravenous analgesia 4\) Age\>18 years 5\) ASA（American Society of Anesthesiologists) grade I-III 6\) Voluntary participation and informed consent
Exclusion criteria
* 1)The anesthesia method for cesarean section is general anesthesia or intraspinal anesthesia, and epidural administration is used 2\) Combined with other opioids during operation 3\) High risk pregnancy (multiple pregnancy, in vitro pregnancy, etc.) or pregnancy related complications (hypertension, preeclampsia, chorioamnionitis, etc.) 4\) Times of previous cesarean section ≥ 3 5\) BMI ≥ 50kg/m2 is not suitable for TAP block 6\) Allergies or contraindications to the drugs involved in the study 7\) Combined with operations other than tubal ligation and ovariectomy 8\) Severe renal function impairment (SCR\>176 µ mol/L and/or blood urea nitrogen\>17.9 mmol/L), severe liver function impairment (ALT and/or aspartate aminotransferase exceed 3 times the upper limit of normal value) 9\) Increased risk of coagulation dysfunction or bleeding (PLT\<80 × 109/L or international normalized ratio\> 1.5) 10\) History of chronic pain or opiate abuse 11\) Other clinical trials in the last three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of hydromorphone | 48 hours after surgery | Consumption of hydromorphone 48 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of hydromorphone | 24 hours after surgery | Consumption of hydromorphone 24 hours after surgery |
| First time to press bolus | 48 hours after surgery | Time between end of surgery and first time to press bolus |
| Attempts of pressing bolus | 48 hours after surgery | Attempts of pressing bolus at 4 hours, 12 hours, 24 hours and 48 hours after surgery respectively |
| Postoperative satisfaction | 48 hours after surgery | Self-planned satisfaction with postoperative analgesia 0 point: dissatisfied, persistent pain, unable to sleep; 1. point: satisfied, slight pain, pain when breathing deeply or coughing; 2. points: very satisfied, painless when breathing deeply or coughing, quiet to sleep |
| Postoperative Ramsay score | 48 hours after surgery | It divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. Level 1 sober: the patient is anxious, restless or irritable; Level 2 sober: the patient is cooperative, has good orientation or is quiet; Level 3 sober: the patient only responds to commands; Level 4 sleep: the patient responds quickly to light tapping between the eyebrows or strong sound stimulation; Grade 5 sleep: the patient is slow to respond to light tapping between the eyebrows or strong sound stimulation; Grade 6 sleep: the patient has no response to light tapping between the eyebrows or strong sound stimulation. |
| Numeric Rating Scale | 48 hours after surgery | Numeric rating scale sores at rest , ambulation and uterine contraction. Postoperative pain will be scored on a scale of 0 to 10 on the NRS, with nil (0) representing no pain and 10 representing the worst imaginable pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 48 hours after surgery | Incidence of adverse events after surgery, eg, pruritus, postoperative nausea and vomiting, dizziness, and respiratory depression |
| Incidence of rescue analgesia | 48 hours after surgery | Parturient women with the NRS at rest\>3 points or the NRS with movement\>6 points will be given hydromorphone 0.3-0.5mg for rescue analgesia |
Countries
China
Outcome results
None listed