TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia

Effect of Dexmedetomidine Combined With Ropivacaine Transverse Abdominal Plane Block (TAP) on Opioid Dosage After Cesarean Section Under Multimodal Analgesia

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Multimodal Analgesia
• Intervention / Treatment: Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xi'an, China, 710032
    • Huang Nie
  • Shannxi
    • Xi'an, Shannxi, China, 710032
      • The Fourth Military Medical University, Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dexmedetomidine + ropivacaine; each side dexmedetomidine 0.5ug/kg+0.25% ropivacaine 20ml TAP block	Drug: Dexmedetomidine; each side dexmedetomidine 0.5ug/kg TAP block
No Intervention: ropivacaine; each side 0.25% ropivacaine 20ml TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of hydromorphone	Consumption of hydromorphone 48 hours after surgery	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of hydromorphone	Consumption of hydromorphone 24 hours after surgery	24 hours after surgery
First time to press bolus	Time between end of surgery and first time to press bolus	48 hours after surgery
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Incidence of adverse events after surgery, eg, pruritus, postoperative nausea and vomiting, dizziness, and respiratory depression	48 hours after surgery
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

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: dexmedetomidine; transversus abdominis plane block
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: KY-20222263-F-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No