TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia

NCT ID: NCT05700045

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2023-09-30

Brief Summary

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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

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Conditions

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Multimodal Analgesia Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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dexmedetomidine + ropivacaine

each side dexmedetomidine 0.5ug/kg+0.25% ropivacaine 20ml TAP block

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

each side dexmedetomidine 0.5ug/kg TAP block

ropivacaine

each side 0.25% ropivacaine 20ml TAP block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexmedetomidine

each side dexmedetomidine 0.5ug/kg TAP block

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Fourth military medical university, Xijing Hospital

Xi'an, Shannxi, China

Site Status

Huang Nie

Xi'an, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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KY-20222263-F-1

Identifier Type: -

Identifier Source: org_study_id

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