Cesarean Section Clinical Trial
Official title:
Effect of Dexmedetomidine Combined With Ropivacaine Transverse Abdominal Plane Block (TAP) on Opioid Dosage After Cesarean Section Under Multimodal Analgesia
Verified date | November 2022 |
Source | Xijing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Huang Nie | Xi'an | |
China | The Fourth military medical university, Xijing Hospital | Xi'an | Shannxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of adverse events | Incidence of adverse events after surgery, eg, pruritus, postoperative nausea and vomiting, dizziness, and respiratory depression | 48 hours after surgery | |
Other | Incidence of rescue analgesia | 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 | 48 hours after surgery | |
Primary | Consumption of hydromorphone | Consumption of hydromorphone 48 hours after surgery | 48 hours after surgery | |
Secondary | Consumption of hydromorphone | Consumption of hydromorphone 24 hours after surgery | 24 hours after surgery | |
Secondary | First time to press bolus | Time between end of surgery and first time to press bolus | 48 hours after surgery | |
Secondary | Attempts of pressing bolus | Attempts of pressing bolus at 4 hours, 12 hours, 24 hours and 48 hours after surgery respectively | 48 hours after surgery | |
Secondary | Numeric Rating Scale | 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. | 48 hours after surgery | |
Secondary | Postoperative satisfaction | Self-planned satisfaction with postoperative analgesia 0 point: dissatisfied, persistent pain, unable to sleep;
point: satisfied, slight pain, pain when breathing deeply or coughing; points: very satisfied, painless when breathing deeply or coughing, quiet to sleep |
48 hours after surgery | |
Secondary | Postoperative Ramsay score | 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. | 48 hours after surgery |
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