TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia

Xijing Hospital90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Multimodal Analgesia Cesarean Section

Interventions

DexmedetomidineDRUG

each side dexmedetomidine 0.5ug/kg TAP block

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

The Fourth military medical university, Xijing Hospital

Xi'an, Shannxi, China

Huang Nie

Xi'an, China

Outcomes

Primary Outcomes

Consumption of hydromorphone

Consumption of hydromorphone 48 hours after surgery

Time frame: 48 hours after surgery

Secondary Outcomes

Consumption of hydromorphone

Consumption of hydromorphone 24 hours after surgery

Time frame: 24 hours after surgery

First time to press bolus

Time between end of surgery and first time to press bolus

Time frame: 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

Time frame: 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.

Time frame: 48 hours after surgery

Postoperative satisfaction

Self-planned satisfaction with postoperative analgesia 0 point: dissatisfied, persistent pain, unable to sleep; 1. point: satisfied, slight pain, pain when breathing deeply or coughing; 2. points: very satisfied, painless when breathing deeply or coughing, quiet to sleep

Time frame: 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.

Data from ClinicalTrials.gov

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