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NCT Number: NCT05700045

TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section 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.

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Key information

Conditions

Multimodal Analgesia Cesarean Section

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) 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

Exclusion criteria

  • 1)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

Treatment and study plan

Dexmedetomidine

Drug

each side dexmedetomidine 0.5ug/kg TAP block

Primary outcomes

  1. Consumption of hydromorphone

    Time frame: 48 hours after surgery

    Consumption of hydromorphone 48 hours after surgery

Secondary outcomes

  1. Consumption of hydromorphone

    Time frame: 24 hours after surgery

    Consumption of hydromorphone 24 hours after surgery

  2. First time to press bolus

    Time frame: 48 hours after surgery

    Time between end of surgery and first time to press bolus

  3. Attempts of pressing bolus

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Incidence of adverse events

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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