TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia

Not Applicable

Completed

• Conditions: Multimodal Analgesia; Cesarean Section
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT05700045
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-26
• Study Start: 2023-05-31
• Primary Completion: 2023-09-28
• Study Completion: 2023-09-30
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine + ropivacaine	Dexmedetomidine	each side dexmedetomidine 0.5ug/kg+0.25% ropivacaine 20ml TAP block

Primary Outcome Measures

Name	Time	Method
Consumption of hydromorphone	48 hours after surgery	Consumption of hydromorphone 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Consumption of hydromorphone	24 hours after surgery	Consumption of hydromorphone 24 hours after surgery
Postoperative Ramsay score	48 hours after surgery	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.
Numeric Rating Scale	48 hours after surgery	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.
Postoperative satisfaction	48 hours after surgery	Self-planned satisfaction with postoperative analgesia 0 point: dissatisfied, persistent pain, unable to sleep; 1. point: satisfied, slight pain, pain when breathing deeply or coughing; 2. points: very satisfied, painless when breathing deeply or coughing, quiet to sleep
First time to press bolus	48 hours after surgery	Time between end of surgery and first time to press bolus
Attempts of pressing bolus	48 hours after surgery	Attempts of pressing bolus at 4 hours, 12 hours, 24 hours and 48 hours after surgery respectively

Trial Locations

Locations (2)

Huang Nie; 🇨🇳 Xi'an, China

The Fourth military medical university, Xijing Hospital; 🇨🇳 Xi'an, Shannxi, China