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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05700045
Other study ID # KY-20222263-F-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2023
Est. completion date September 30, 2023

Study information

Verified date November 2022
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
each side dexmedetomidine 0.5ug/kg TAP block

Locations

Country Name City State
China Huang Nie Xi'an
China The Fourth military medical university, Xijing Hospital Xi'an Shannxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

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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