Back to resultsTAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia
Primary Purpose
Multimodal Analgesia, Cesarean Section
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Multimodal Analgesia focused on measuring dexmedetomidine, transversus abdominis plane block
Eligibility Criteria
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
Sites / Locations
- The Fourth military medical university, Xijing Hospital
- Huang Nie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
dexmedetomidine + ropivacaine
ropivacaine
Arm Description
each side dexmedetomidine 0.5ug/kg+0.25% ropivacaine 20ml TAP block
each side 0.25% ropivacaine 20ml TAP block
Outcomes
Primary Outcome Measures
Consumption of hydromorphone
Consumption of hydromorphone 48 hours after surgery
Secondary Outcome Measures
Consumption of hydromorphone
Consumption of hydromorphone 24 hours after surgery
First time to press bolus
Time between end of surgery and first time to press bolus
Attempts of pressing bolus
Attempts of pressing bolus at 4 hours, 12 hours, 24 hours and 48 hours after surgery respectively
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05700045
Brief Title
TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia
Official Title
Effect of Dexmedetomidine Combined With Ropivacaine Transverse Abdominal Plane Block (TAP) on Opioid Dosage After Cesarean Section Under Multimodal Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
September 28, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multimodal Analgesia, Cesarean Section
Keywords
dexmedetomidine, transversus abdominis plane block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine + ropivacaine
Arm Type
Experimental
Arm Description
each side dexmedetomidine 0.5ug/kg+0.25% ropivacaine 20ml TAP block
Arm Title
ropivacaine
Arm Type
No Intervention
Arm Description
each side 0.25% ropivacaine 20ml TAP block
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
each side dexmedetomidine 0.5ug/kg TAP block
Primary Outcome Measure Information:
Title
Consumption of hydromorphone
Description
Consumption of hydromorphone 48 hours after surgery
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
Consumption of hydromorphone
Description
Consumption of hydromorphone 24 hours after surgery
Time Frame
24 hours after surgery
Title
First time to press bolus
Description
Time between end of surgery and first time to press bolus
Time Frame
48 hours after surgery
Title
Attempts of pressing bolus
Description
Attempts of pressing bolus at 4 hours, 12 hours, 24 hours and 48 hours after surgery respectively
Time Frame
48 hours after surgery
Title
Numeric Rating Scale
Description
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.
Time Frame
48 hours after surgery
Title
Postoperative satisfaction
Description
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
Time Frame
48 hours after surgery
Title
Postoperative Ramsay score
Description
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.
Time Frame
48 hours after surgery
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events
Description
Incidence of adverse events after surgery, eg, pruritus, postoperative nausea and vomiting, dizziness, and respiratory depression
Time Frame
48 hours after surgery
Title
Incidence of rescue analgesia
Description
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
Time Frame
48 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Fourth military medical university, Xijing Hospital
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710032
Country
China
Facility Name
Huang Nie
City
Xi'an
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
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TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia
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