Analgesia Effects of Nalbuphine vs Sulfentanil

Study Overview
=================
Brief Summary
-----------------
Cesarean section may result in great trauma and postoperative pain. Besides incision pain, uterine contraction pain is another source of postoperative pain after cesarean section. In clinical practice, a large amount of uterine contraction agent is routinely applied after cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage, which also causes great uterine contraction pain. Acute pain is the risk factor of chronic pain, and may postpone the recovery from labour and influence the quality of life of parturient. Though various analgesia modules have been attempted, more than 20% parturients still experience severe postoperative pain, and pain management after cesarean section remains a challenge to anesthesiologists. This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on patient-controlled intravenous analgesia after cesarean section.

Detailed Description
-----------------
Cesarean section may result in great trauma and postoperative pain. Besides incision pain, uterine contraction pain is another source of postoperative pain after cesarean section. In clinical practice, a large amount of uterine contraction agent is routinely applied after cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage, which also causes great uterine contraction pain. Acute pain is the risk factor of chronic pain, and may postpone the recovery from labour and influence the quality of life of parturient. Though various analgesia modules have been attempted, more than 20% parturients still experience severe postoperative pain, and pain management after cesarean section remains a challenge to anesthesiologists. Opiate drugs constitute the baseline medication for postoperative analgesia. However, pure μ opioid receptor agonist like morphine and fentanyl may induce adverse effects such as nausea, vomiting, dizziness, drowsiness and respiratory depression. Nalbuphine hydrochloride is an opiate-like substance structure-related oxymorphone, which is a κ receptor agonist/μ receptor partial antagonistic type analgesia drug. Specific κ receptor agonist and gene knockout experiment reveals that κ receptor agonist depresses the visceral pain induced by chemical stimulation, the effect of which outperforms pure μ opioid receptor agonist. Studies have discovered that some κ receptor agonists can reduce or inhibit the side effects of μ receptor agonist such as tolerance or dependence. The adverse effects of μ receptor agonist such as pruritus, nausea, vomiting, delayed gastric emptying are caused by the drug on peripheral opioid receptor, and can be relieved by opioid receptor agonist. The structure of nalbuphine hydrochloride is related to naloxone, an opioid receptor antagonist, therefore, the incidence of adverse effects of nalbuphine hydrochloride is lower than that of μ receptor agonist. In recent years, nalbuphine hydrochloride has become more and more popular in postoperative analgesia. There has been reports on intrathecal administration of nalbuphine hydrochloride for analgesia after cesarean section, while the effect of intravenous administration of nalbuphine hydrochloride on analgesia after cesarean section remains undetermined. This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on patient-controlled intravenous analgesia after cesarean section.

Official Title
-----------------
Analgesia Effects of Nalbuphine vs Sulfentanil in Patient-controlled Intravenous Analgesia After Cesarean Section

Conditions
-----------------
C.Delivery; Surgery (Previous), Gynecological

Intervention / Treatment
-----------------
* Drug: Nalbuphine
* Drug: Sufentanil
* Drug: flurbiprofen axetil
* Drug: ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For primipara with selective cesarean section Exclusion Criteria: Severe preeclampsia, pregnancy complicated with diabetes mellitus pregnancy complicated with cardiac disease, gestation age<37W recently use of opiate drugs or nonsteroidal antiinflammatory drugs within 48 h before operation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nalbuphine<br>Nalbuphine group: nalbuphine 100 mg, ramosetron 0.3mg, background dose 1ml/h,patient-controlled analgesia(PCA) 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation. | Drug: Nalbuphine<br>* patient-controlled intravenous analgesia<br>* Other names: nalbuphine 100 mg;Drug: flurbiprofen axetil<br>* patient-controlled intravenous analgesia<br>* Other names: flurbiprofen axetil 50mg;Drug: ramosetron<br>* patient-controlled intravenous analgesia<br>* Other names: ramosetron 0.3mg;|
| Experimental: Sufentanil<br>Sufentanil group: sufentanil 100ug, ramosetron 0.3mg, background dose 1ml/h, PCA 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation. | Drug: Sufentanil<br>* patient-controlled intravenous analgesia<br>* Other names: sufentanil 100ug;Drug: flurbiprofen axetil<br>* patient-controlled intravenous analgesia<br>* Other names: flurbiprofen axetil 50mg;Drug: ramosetron<br>* patient-controlled intravenous analgesia<br>* Other names: ramosetron 0.3mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores of nalbuphine group |  | up to 24 months | 
| Pain scores of sufentanil group |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of nalbuphine of nalbuphine group |  | up to 24 months | 
| Usage of sufentanil of sufentanil group |  | up to 24 months |