Clinical trial NCT05700045: TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia
Official title: Effect of Dexmedetomidine Combined With Ropivacaine Transverse Abdominal Plane Block (TAP) on Opioid Dosage After Cesarean Section Under Multimodal Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimodal Analgesia
Cesarean Section
Keywords: dexmedetomidine
transversus abdominis plane block
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Consumption of hydromorphone
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Consumption of hydromorphone
timeFrame: 24 hours after surgery
measure: First time to press bolus
timeFrame: 48 hours after surgery
measure: Attempts of pressing bolus
timeFrame: 48 hours after surgery
measure: Numeric Rating Scale
timeFrame: 48 hours after surgery
measure: Postoperative satisfaction
timeFrame: 48 hours after surgery
measure: Postoperative Ramsay score
timeFrame: 48 hours after surgery
Other outcomes:
measure: Incidence of adverse events
timeFrame: 48 hours after surgery
measure: Incidence of rescue analgesia
timeFrame: 48 hours after surgery
Locations:
city: Xi'an
country: China
facility: The Fourth military medical university, Xijing Hospital
state: Shannxi
city: Xi'an
country: China
facility: Huang Nie
Study officials:
References: