TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia

NCT05700045 | Completed

• 1 other identifier: KY-20222263-F-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Multimodal Analgesia; Cesarean Section

Keywords

dexmedetomidine; transversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

• Consumption of hydromorphone

  Consumption of hydromorphone 48 hours after surgery

  48 hours after surgery

Secondary Outcomes (6)

• Consumption of hydromorphone

  24 hours after surgery

• First time to press bolus

  48 hours after surgery

• Attempts of pressing bolus

  48 hours after surgery

• Numeric Rating Scale

  48 hours after surgery

• Postoperative satisfaction

  48 hours after surgery

Other Outcomes (2)

• Incidence of adverse events

  48 hours after surgery

• Incidence of rescue analgesia

  48 hours after surgery

Study Arms (2)

dexmedetomidine + ropivacaine

EXPERIMENTAL

each side dexmedetomidine 0.5ug/kg+0.25% ropivacaine 20ml TAP block

Drug: Dexmedetomidine

ropivacaine

NO INTERVENTION

each side 0.25% ropivacaine 20ml TAP block

Interventions

Dexmedetomidine DRUG

each side dexmedetomidine 0.5ug/kg TAP block

dexmedetomidine + ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 37-42 weeks of gestation
• \) Plan cesarean section
• \) Receiving patient controlled intravenous analgesia
• \) Age\>18 years
• \) ASA（American Society of Anesthesiologists) grade I-III
• \) Voluntary participation and informed consent

You may not qualify if:

• )The anesthesia method for cesarean section is general anesthesia or intraspinal anesthesia, and epidural administration is used
• \) Combined with other opioids during operation
• \) High risk pregnancy (multiple pregnancy, in vitro pregnancy, etc.) or pregnancy related complications (hypertension, preeclampsia, chorioamnionitis, etc.)
• \) Times of previous cesarean section ≥ 3
• \) BMI ≥ 50kg/m2 is not suitable for TAP block
• \) Allergies or contraindications to the drugs involved in the study
• \) Combined with operations other than tubal ligation and ovariectomy
• \) 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)
• \) Increased risk of coagulation dysfunction or bleeding (PLT\<80 × 109/L or international normalized ratio\> 1.5)
• \) History of chronic pain or opiate abuse
• \) Other clinical trials in the last three months

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (2)

The Fourth military medical university, Xijing Hospital

Xi'an, Shannxi, 710032, China

Location

Huang Nie

Xi'an, 710032, China

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 26, 2023
• Study Start: May 31, 2023
• Primary Completion: September 28, 2023
• Study Completion: September 30, 2023
• Last Updated: October 11, 2023

Record last verified: 2022-11

Locations

CN (2)