TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05700045
• Other study ID #: KY-20222263-F-1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cesarean Section
• Multimodal Analgesia

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