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TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia

Sponsor
Xijing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05700045
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
9.3
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Effect of Dexmedetomidine Combined With Ropivacaine Transverse Abdominal Plane Block (TAP) on Opioid Dosage After Cesarean Section Under Multimodal Analgesia
Anticipated Study Start Date :
Jan 20, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Consumption of hydromorphone [48 hours after surgery]

    Consumption of hydromorphone 48 hours after surgery

Secondary Outcome Measures

  1. Consumption of hydromorphone [24 hours after surgery]

    Consumption of hydromorphone 24 hours after surgery

  2. First time to press bolus [48 hours after surgery]

    Time between end of surgery and first time to press bolus

  3. 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

  4. 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.

  5. Postoperative satisfaction [48 hours after surgery]

    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

  6. 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.

Other Outcome Measures

  1. Incidence of adverse events [48 hours after surgery]

    Incidence of adverse events after surgery, eg, pruritus, postoperative nausea and vomiting, dizziness, and respiratory depression

  2. Incidence of rescue analgesia [48 hours after surgery]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. 37-42 weeks of gestation

  1. Plan cesarean section

  2. Receiving patient controlled intravenous analgesia

  3. Age>18 years

  4. ASA（American Society of Anesthesiologists) grade I-III

  5. 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

  1. Combined with other opioids during operation

  2. High risk pregnancy (multiple pregnancy, in vitro pregnancy, etc.) or pregnancy related complications (hypertension, preeclampsia, chorioamnionitis, etc.)

  3. Times of previous cesarean section ≥ 3

  4. BMI ≥ 50kg/m2 is not suitable for TAP block

  5. Allergies or contraindications to the drugs involved in the study

  6. Combined with operations other than tubal ligation and ovariectomy

  7. 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)

  8. Increased risk of coagulation dysfunction or bleeding (PLT<80 × 109/L or international normalized ratio> 1.5)

  9. History of chronic pain or opiate abuse

  10. Other clinical trials in the last three months

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affilated Hospital of Fourth Military Medical University Xi'an Shaanxi China

Sponsors and Collaborators

  • Xijing Hospital

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT05700045
Other Study ID Numbers:
  • KY-20222263-F-1
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xijing Hospital
dexmedetomidine
transversus abdominis plane block
Additional relevant MeSH terms:
Agnosia
Dexmedetomidine

Study Results

No Results Posted as of Jan 26, 2023